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Takeda Pharmaceuticals

125 💼 Takeda Pharmaceuticals Jobs / Employment

Manager, Clinical Data Solutions - Cambridge

newabout 5 hours ago
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Job DescriptionAre you looking for a patient-focused company that will inspire you and support your career If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Clinical Data Solutions in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Clinical Data Solutions team, you will be empowered to support the Takeda portfolio and participate in oversight activities, and a typical day will include: POSITION OBJECTIVES: Responsible for timely and high quality data management deliverables supporting the Takeda portfolio. Confirms asset and study level strategies and services are being implemented at the study level, including the application of standards. Conducts oversight of data management activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda s obligations described in ICH-GCP and Takeda s business objectives. Activities include from protocol synopsis through database release and submissionContributes to the management of vendor partnerships to verify contractual assumptions in the study SOWs including the verification of monthly invoices. Acts as a first point of contact for CRO partners seeking sponsor input on study level problem solving and decision making. Serves as an expert for clinical data management best practices and acts as an ambassador on CDISC standards. POSITION ACCOUNTABILITIES: Participates in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions. Serves as a first point of contact for CROs partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality. Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. Acts as a process expert for operational and oversight models. Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models. May prepare metrics to support the function s KPIs. Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones. Confirms archival and inspection readiness of all Data Management Trial Master File (TMF) documentsVerifies external Data Management SOWs and timelines to ensure accuracy of invoices, investigates variances and supports forecasting. Participates in preparing function for submission readiness and may represent function in a formal inspection or audit. Other duties as assignedEDUCATION, EXPERIENCE AND SKILLS: BS/BA required preferably in a health-related, life science area and with a minimum of 6 years data management and/or drug development experience. Proven track record of strong project management skills and experience managing data management activities for large drug development programsExperience with all phases of development and at least 2 therapeutic areas. Ability to handle multiple development programs simultaneously. NDA/CTD Experience. Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials. Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance. Good understanding of CDISC standards, and experience implementing standards. Strong knowledge of clinical study reporting requirements including SAS programming. Advanced knowledge of office software (Microsoft Office). Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles. Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools. Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes. Demonstrated strong matrix leadership and communication skillsAble to influence without authorityExcellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skillsEntrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quoPragmatic and support changeIs comfortable with ambiguityPHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ability to sit and stand for long periods of time. Carrying, handling and reaching for objects. Manual dexterity to operate office equipment i. e. computers, phones, etc. TRAVEL REQUIREMENTS: Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution PlanTuition reimbursementCompany match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs

Regulatory Tech & IM Manager

newabout 16 hours ago
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Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification has been filed by Takeda Human Genetic Therapies Inc. for the following job opportunity: JOB LOCATION: Cambridge, MA POSITION: Regulatory Tech & IM Manager POSITION DESCRIPTION: Takeda Human Genetic Therapies Inc. is seeking a Regulatory Tech & IM Manager with the following duties: provide technical and business support to the Global R&D users that are using the Global Regulatory Systems and Applications; ensure that GRA requirements are incorporated and supported by both new systems and also upgraded to existing systems, in partnership with R&D IT; provide recommendations in formulating new technology and guidance; Provide Business User support and recommendations on the structure and preparation of electronic regulatory specifications and submissions and the ability of publishing tools and systems to support them; represent Global Regulatory Affairs (GRA) as a Subject Matter Expert, providing both business and technical solutions for GRA systems, developing and maintaining supporting information related to the use of GRA systems, e.g. system job aid/ help guide; collaborate with the respective R&D Information Technology teams to drive the development and update of Global Regulatory requirements, processes and standards; establish, update and implement Regulatory required formats, templates, policies, standards, and procedures for regulatory submissions; maintain up-to-date knowledge of global standards and procedures for regulatory submissions, including eCTD, IDMP; publish standards and analyze new and revised guidance, advice regulatory management of new requirements, and recommend course of action; provide recommendations on the approach for the application of expert knowledge of global regulatory; ensure budgets, schedules and performance requirements are met; act as subject matter expert (SME) for GRA System; provide technical and business support for R&D systems; manage support, troubleshooting and communicate with business; act as key contact from IT for business; identify solutions for critical business needs; perform process development methodologies specific to Pharma and validated systems. REQUIREMENTS: Bachelor's degree in Engineering, Computer Science or related field plus 6 years related experience. Will accept any level of experience in the following required skills: act as subject matter expert (SME) for GRA System; provide technical and business support for R&D systems; manage support, troubleshooting and communicate with business; act as key contact from IT for business; identify solutions for critical business needs; perform process development methodologies specific to Pharma and validated systems. Full time. $108,000.00 - $146,000.00/year. Competitive compensation and benefits. Qualified applicants can apply directly to the Takeda careers page at: https://jobs.Takeda.com. Please reference job R0029182. EOE Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Foreign Labor Certification National Processing Center, Harris Tower, 233 Peachtree Street, Suite 410, Atlanta, GA 30303.

jobs byAdzuna

Product Medical Lead

newabout 16 hours ago
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Responsibilities % of Time 20% Support development of US medical strategy and plans with alignment with Global Medical Team Work with GMTL and Global Franchise and Product Leads to develop US medical plans that include tactics to support key strategic imperatives for the disease area / brand(s) in both pre- and post- launch setting. Support development of the in-year medical tactical plan and budget for US initiatives and where applicable, collaborate with Global initiatives As delegated by the GMTL functional (e.g. publications, medical communications, medical information and medical training) plans supporting US medical strategy with alignment with Global where applicable. As delegated by the GMTL, collaborate with relevant business partners to ensure aligned and medically appropriate brand strategy, planning and execution As delegated by US,GMTL, participate in product development strategy and provide medical affairs and R&D inputs 40 Implementation in-year of US medical strategy with global alignment As delegated by the GMTL and IMM Franchise Head, directly implement plans in the US and collaborate with Global Franchise and Product Leads, potentially including: Development and implementation of medical pre- and post- launch plans for late-stage pipeline products or product label expansions for US Providing medical leadership for scientific communications, including core scientific statements, standard responses, Phase IV plans, and publications Planning, designing and managing or participating in local, regional, national and global medical Advisory Boards including working with vendor(s) to ensure timely submission and approval in RnD select Providing medical review of Investigator Initiated Research (IIR) proposals and other grants through the grant approval process as designated GMTL Managing design and execution of clinical studies (phase IIIb/IV, disease registries, HEOR studies, outcomes surveys, etc.) in close collaboration with Global Franchise and Product Leads, Scientific Affairs, Shared Medical Excellence and Clinical Operations Managing completion of regulatory obligations (e.g. medical affairs input in safety review teams (SRTs). Monitoring and communicating progress against medical plan; propose and initiate initiatives as need to adjust to disease area requirements Conducting and ensuring timely medical review and approval of promotional and meeting materials as required per SOP Serving as US Medical representative on standing and project-based cross-functional teams Serving as Global Medical representative on standing and project-based cross-functional teams 30 Effective compliant collaborations with internal stakeholders (R&D, commercial, marketing, regulatory, legal, and compliance) and scientific exchanges with external stakeholders (KOLs and HCPs) in alignment with customer needs and medical strategy Act as a company medical representative to engage external scientific leaders, policy makers, patient advocacy groups and/or regulatory authorities Per medical strategy, establish and/or enhance partnerships with key academic institutions and develop relationships with key thought leaders Per medical strategy, establish appropriate partnerships with KOLs in areas of scientific interest. Represent Medical Affairs at internal and external meetings Present data on product / disease area at internal and external meetings 10 Maintenance of knowledge base Serve as a key medical resource on the disease area and on specific product Maintain a high level of expertise on the disease area Develop and maintain knowledge of US and International pharmaceutical regulations, guidelines codes of practices and Takeda policies related to all medical activities As directed by the GMTL and Global Franchise,, Product Leads will develop, conduct, or participate in therapeutic training programs for Takeda internal department Education and Experience Requirements A Doctor Degree in Medicine (MD), PhD, or PharmD is required. At least 5 years of related work experience in industry, clinical or research institution, preferably in genetics, metabolic, pulmonary, hematology or AATD related experiences Experience in medical affairs particularly rare disease is preferred Experience in supporting brands or disease area levels in country, regional or global organizations is preferred Experience in other relevant disease areas of interest through clinical experience, biopharmaceutical experience or education may be considered Other Job Requirements Availability to travel domestically and internationally as needed for approximately 20-30% of time Some activities may call for early or late meetings and attendances at scientific meetings on holidays and weekends

jobs byAdzuna

Lead, Human Factors Engineering

newabout 16 hours ago
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To Be Completed by Hiring Manager Primary Duties Provide a brief summary describing the major role, responsibility and purpose of the job. Summarize key areas of accountability and budget responsibility, if applicable. The Lead, Human Factors Engineering will lead human factors work to support the development of devices and combination products for delivery of Takeda’s wide portfolio of drugs and biologics. As part of human factors work, the Lead will also be responsible for planning and executing early stage user research, focusing on unmet user needs, to inform development. Responsibilities Describe the essential daily job functions and include % of time spent on each. % of Time Job Function and Description 25% Work with external human factors consultants to plan, conduct and report out early stage user research, including developing proposals for user research for different products 25% With little direction, responsible for leading all activities needed to support human factors deliverables for a device or combination product development project 15% Build an internal understanding of Takeda product users through synthesis of user research outputs. This includes creating tools to organize and reference user research outputs for device and combination product development 15% Actively participate on device and combination product development teams to ensure human factors engineering and user research inputs are considered and implemented at appropriate points in the development process 10% Create and communicate project plans, tasks and deliverables. This includes reporting information at key milestones through clear written and verbal communications 10% Lead efforts to develop processes and procedures that align to company initiatives and relevant human factors engineering standards Education and Experience Requirements B.S. in Human Factors Engineering, or equivalent. A minimum or 12 years of human factors engineering experience – OR – M.S. in Human Factors Engineering, or equivalent. A minimum of 8 years of human factors engineering experience – OR – Ph. D. in Human Factors Engineering, or equivalent. A minimum of 4 years of human factors engineering experience Key Skills, Abilities, and Competencies Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Demonstrated ability to provide technical leadership for human factors engineering aspects of device and combination product development Understanding of user-centered design, heuristic evaluations, design of experiments, usability testing and statistical analysis Experience in the design and conduct of user research (e.g., discussion guide development, session moderation) Experience implementing HFE standards and guidances Ability to draw conclusions and make recommendation based on technical inputs from multiple sources Ability to be collaborative and flexible in approach to solving human factors challenges Strong communication skills and ability to perform within a cross-functional team environment Understanding of Quality System Regulations Experience with operating in a regulated environment (e.g., FDA) with an understanding of associated implications for design of medical devices and combination products a plus Experience interacting with regulatory agencies via written responses and/or live meetings a plus Complexity and Problem Solving Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent’s authority to make as well as those decisions that must be referred to a higher level. Responsible for determining approach for human factors work, including tailoring HF deliverables based on risk associated with the product (i.e., use-related risk, regulatory risk, business risk, etc.). This includes determining the scale and timing of required user research, formative and summative human factors evaluations. Internal and External Contacts List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and provide examples. This role interacts extensively with a wide variety of internal contacts, most notably individuals in engineering, quality, clinical & medical affairs, regulatory affairs, commercial, legal and purchasing. This role interacts extensively with external HF consultants. The Lead will be responsible for selecting consultants to perform HF research and studies, and managing the work of consultants throughout the engagements. Other Job Requirements List any other job requirements, including travel, physical abilities required, etc. Some travel, up to 25%

jobs byAdzuna

Manager, Clinical Data Solutions - Cambridge

newabout 24 hours ago
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Job DescriptionAre you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Clinical Data Solutions in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Clinical Data Solutions team, you will be empowered to support the Takeda portfolio and participate in oversight activities, and a typical day will include: POSITION OBJECTIVES: Responsible for timely and high quality data management deliverables supporting the Takeda portfolio. Confirms asset and study level strategies and services are being implemented at the study level, including the application of standards. Conducts oversight of data management activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda s obligations described in ICH-GCP and Takeda s business objectives. Activities include from protocol synopsis through database release and submissionContributes to the management of vendor partnerships to verify contractual assumptions in the study SOWs including the verification of monthly invoices. Acts as a first point of contact for CRO partners seeking sponsor input on study level problem solving and decision making. Serves as an expert for clinical data management best practices and acts as an ambassador on CDISC standards. POSITION ACCOUNTABILITIES: Participates in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions. Serves as a first point of contact for CROs partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality. Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. Acts as a process expert for operational and oversight models. Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models. May prepare metrics to support the function s KPIs. Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones. Confirms archival and inspection readiness of all Data Management Trial Master File (TMF) documentsVerifies external Data Management SOWs and timelines to ensure accuracy of invoices, investigates variances and supports forecasting. Participates in preparing function for submission readiness and may represent function in a formal inspection or audit. Other duties as assignedEDUCATION, EXPERIENCE AND SKILLS: BS/BA required preferably in a health-related, life science area and with a minimum of 6 years data management and/or drug development experience. Proven track record of strong project management skills and experience managing data management activities for large drug development programsExperience with all phases of development and at least 2 therapeutic areas. Ability to handle multiple development programs simultaneously. NDA/CTD Experience. Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials. Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance. Good understanding of CDISC standards, and experience implementing standards. Strong knowledge of clinical study reporting requirements including SAS programming. Advanced knowledge of office software (Microsoft Office). Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles. Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools. Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes. Demonstrated strong matrix leadership and communication skillsAble to influence without authorityExcellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skillsEntrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quoPragmatic and support changeIs comfortable with ambiguityPHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ability to sit and stand for long periods of time. Carrying, handling and reaching for objects. Manual dexterity to operate office equipment i. e. computers, phones, etc. TRAVEL REQUIREMENTS: Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution PlanTuition reimbursementCompany match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs

Manager, Clinical Data Solutions - Cambridge

new1 day ago
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Job DescriptionAre you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Clinical Data Solutions in our Cambridge office.Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Clinical Data Solutions team, you will be empowered to support the Takeda portfolio and participate in oversight activities, and a typical day will include:POSITION OBJECTIVES:Responsible for timely and high quality data management deliverables supporting the Takeda portfolio. Confirms asset and study level strategies and services are being implemented at the study level, including the application of standards. Conducts oversight of data management activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda s obligations described in ICH-GCP and Takeda s business objectives. Activities include from protocol synopsis through database release and submissionContributes to the management of vendor partnerships to verify contractual assumptions in the study SOWs including the verification of monthly invoices. Acts as a first point of contact for CRO partners seeking sponsor input on study level problem solving and decision making. Serves as an expert for clinical data management best practices and acts as an ambassador on CDISC standards. POSITION ACCOUNTABILITIES:Participates in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions. Serves as a first point of contact for CROs partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality. Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. Acts as a process expert for operational and oversight models. Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models. May prepare metrics to support the function s KPIs. Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones. Confirms archival and inspection readiness of all Data Management Trial Master File (TMF) documentsVerifies external Data Management SOWs and timelines to ensure accuracy of invoices, investigates variances and supports forecasting. Participates in preparing function for submission readiness and may represent function in a formal inspection or audit. Other duties as assignedEDUCATION, EXPERIENCE AND SKILLS:BS/BA required preferably in a health-related, life science area and with a minimum of 6 years data management and/or drug development experience. Proven track record of strong project management skills and experience managing data management activities for large drug development programsExperience with all phases of development and at least 2 therapeutic areas. Ability to handle multiple development programs simultaneously. NDA/CTD Experience. Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials. Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance. Good understanding of CDISC standards, and experience implementing standards. Strong knowledge of clinical study reporting requirements including SAS programming. Advanced knowledge of office software (Microsoft Office). Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles. Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools. Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes. Demonstrated strong matrix leadership and communication skillsAble to influence without authorityExcellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skillsEntrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quoPragmatic and support changeIs comfortable with ambiguityPHYSICAL DEMANDS:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Ability to sit and stand for long periods of time. Carrying, handling and reaching for objects. Manual dexterity to operate office equipment i. e. computers, phones, etc. TRAVEL REQUIREMENTS:Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. WHAT TAKEDA CAN OFFER YOU:401(k) with company match and Annual Retirement Contribution PlanTuition reimbursementCompany match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs

Associate Program Leader - Clinical Operations

new1 day ago
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Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Program Leader - Clinical Operations in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Program Leader working on the Clinical Operations team, you will be empowered to lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan, and a typical day will include: OBJECTIVES: In close collaboration with Clinical Operations Program Leads Responsible for oversight of the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Oversight of Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda s obligations described in ICH-GCP and Takeda s business objectives. The assigned clinical studies may be high complexity or high risk, e. g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned. ACCOUNTABILITIES: Accountable for planning and operational strategy for assigned clinical trialsProvides subject matter expertise and operational input into protocol synopsis and final protocol documentChallenges study team to ensure operational feasibility, inclusive of patient and site burdenValidates budget and ensures impacts are adequately addressedParticipates in country and site selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategyChallenges study team to ensure timelines meet the needs of the clinical development planWith Strategic Partner(s) and/or other CROs, support the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in placeProvide support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidlyResponsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s) , Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Leader(s) ; serve as escalation point for third party vendors managed by Strategic Partner and/or other CROsOversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted;Specific areas of sponsor oversight include, but are not limited to:Review and approval of key risk based monitoring documents/plans, periodic review of outputs, decisions and actions related to risk based monitoringReview and endorsement of Data Management Strategy and Operational Plan, a document which focuses on data concepts and data management principles at the study levelStudy team (SET/CTWG) meeting attendance when necessary; regular review of meeting agendas and minutesReview of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the studyDocumented review and monitoring of issues, risks and decisions at the study levelIn partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i. e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Education: Bachelor s Degree or international equivalent required, Life Sciences preferred. Skills: Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. Demonstrated excellence in project/program management and matrix leadershipExcellent teamwork, organizational, interpersonal, and problem solving skillsFluent business English (oral and written)Experience: 5 years experience in pharmaceutical industry and/or clinical research organization, sponsor preferred, including 3 years clinical study management preferred. Experience must include early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ability to sit and stand for long periods of time. Carrying, handling and reaching for objects. Manual dexterity to operate office equipment i. e. computers, phones, etc. TRAVEL REQUIREMENTS: Requires approximately 10-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution PlanTuition reimbursementCompany match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach ProgramsEmpowering Our People to Shine

jobs byAdzuna

Manager, Clinical Data Solutions

new1 day ago
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Job DescriptionAre you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Clinical Data Solutions in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Clinical Data Solutions team, you will be empowered to support the Takeda portfolio and participate in oversight activities, and a typical day will include: POSITION OBJECTIVES: Responsible for timely and high quality data management deliverables supporting the Takeda portfolio. Confirms asset and study level strategies and services are being implemented at the study level, including the application of standards. Conducts oversight of data management activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda s obligations described in ICH-GCP and Takeda s business objectives. Activities include from protocol synopsis through database release and submissionContributes to the management of vendor partnerships to verify contractual assumptions in the study SOWs including the verification of monthly invoices. Acts as a first point of contact for CRO partners seeking sponsor input on study level problem solving and decision making. Serves as an expert for clinical data management best practices and acts as an ambassador on CDISC standards. POSITION ACCOUNTABILITIES: Participates in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions. Serves as a first point of contact for CROs partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality. Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. Acts as a process expert for operational and oversight models. Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models. May prepare metrics to support the function s KPIs. Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones. Confirms archival and inspection readiness of all Data Management Trial Master File (TMF) documentsVerifies external Data Management SOWs and timelines to ensure accuracy of invoices, investigates variances and supports forecasting. Participates in preparing function for submission readiness and may represent function in a formal inspection or audit. Other duties as assignedEDUCATION, EXPERIENCE AND SKILLS: BS/BA required preferably in a health-related, life science area and with a minimum of 6 years data management and/or drug development experience. Proven track record of strong project management skills and experience managing data management activities for large drug development programsExperience with all phases of development and at least 2 therapeutic areas. Ability to handle multiple development programs simultaneously. NDA/CTD Experience. Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials. Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance. Good understanding of CDISC standards, and experience implementing standards. Strong knowledge of clinical study reporting requirements including SAS programming. Advanced knowledge of office software (Microsoft Office). Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles. Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools. Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes. Demonstrated strong matrix leadership and communication skillsAble to influence without authorityExcellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skillsEntrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quoPragmatic and support changeIs comfortable with ambiguityPHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ability to sit and stand for long periods of time. Carrying, handling and reaching for objects. Manual dexterity to operate office equipment i. e. computers, phones, etc. TRAVEL REQUIREMENTS: Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution PlanTuition reimbursementCompany match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs

jobs byAdzuna

Associate Program Leader - Clinical Operations

new2 days ago
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Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Program Leader - Clinical Operations in our Cambridge office.Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Program Leader working on the Clinical Operations team, you will be empowered to lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan, and a typical day will include:OBJECTIVES:In close collaboration with Clinical Operations Program LeadsResponsible for oversight of the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Oversight of Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda s obligations described in ICH-GCP and Takeda s business objectives. The assigned clinical studies may be high complexity or high risk, e. g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned.ACCOUNTABILITIES:Accountable for planning and operational strategy for assigned clinical trialsProvides subject matter expertise and operational input into protocol synopsis and final protocol documentChallenges study team to ensure operational feasibility, inclusive of patient and site burdenValidates budget and ensures impacts are adequately addressedParticipates in country and site selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategyChallenges study team to ensure timelines meet the needs of the clinical development planWith Strategic Partner(s) and/or other CROs, support the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in placeProvide support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidlyResponsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s) , Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Leader(s) ; serve as escalation point for third party vendors managed by Strategic Partner and/or other CROsOversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted;Specific areas of sponsor oversight include, but are not limited to:Review and approval of key risk based monitoring documents/plans, periodic review of outputs, decisions and actions related to risk based monitoringReview and endorsement of Data Management Strategy and Operational Plan, a document which focuses on data concepts and data management principles at the study levelStudy team (SET/CTWG) meeting attendance when necessary; regular review of meeting agendas and minutesReview of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the studyDocumented review and monitoring of issues, risks and decisions at the study levelIn partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i. e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Education: Bachelor s Degree or international equivalent required, Life Sciences preferred.Skills:Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. Demonstrated excellence in project/program management and matrix leadershipExcellent teamwork, organizational, interpersonal, and problem solving skillsFluent business English (oral and written)Experience: 5+ years experience in pharmaceutical industry and/or clinical research organization, sponsor preferred, including 3+ years clinical study management preferred. Experience must include early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.PHYSICAL DEMANDS:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Ability to sit and stand for long periods of time. Carrying, handling and reaching for objects. Manual dexterity to operate office equipment i. e. computers, phones, etc. TRAVEL REQUIREMENTS:Requires approximately 10-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.WHAT TAKEDA CAN OFFER YOU:401(k) with company match and Annual Retirement Contribution PlanTuition reimbursementCompany match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach ProgramsEmpowering Our People to Shine

Associate Director, Computational and Statistical Genetics

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Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Computational and Statistical Genetics, in our San Diego office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Computational and Statistical Genetics working on the Computational Biology team, you will be empowered to lead a team and perform computational and statistical analysis of human genetics data sets POSITION OBJECTIVES: The Associate Director will be part of a team focused on computational biology support of discovery research and translational science. S/he will lead a group of experts in computational and statistical genetics to generate insights from big human data to support reverse and forward translation across multiple therapeutic areas of interest of Takeda. The Associate Director will apply expertise in statistical genetics, computational biology and genomics to analyze biobank, population scale molecular profiling and phenotype data for the identification and characterization of genes, networks and pathways involved in normal and perturbed physiology. This information will be used to understand the molecular basis of disease pathology and the mechanism of action of drugs, and ultimately be used for selection and progression of drug targets and assets. POSITION ACCOUNTABILITIES: Sets strategic direction, develops tactical plans, motivates, develops and leads team to execute projects effectively Applies statistical genetics analyses to large scale internal and external genetics and genomics data to support or falsify target hypotheses and support patient and indication selection and biomarker development. Performs computational analysis of WES, RNA-seq, other OMICS and real-world data from internal, collaboration and public sources. Applies unsupervised and supervised machine learning and other advanced algorithms to extract novel biologically meaningful information. Integrates genomics, genetics, epigenetics, proteomics and literature data to strengthen understanding of diseases and treatment perturbations. Interact with the external scientific community to bring cutting-edge statistical and computational methods to bear on drug development. Provides analysis and interpretation of data, specifically for the selection of new drug targets and indications Writes study reports and presents data effectively in all settings and with participants of all levels of the organization. EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS: PhD or equivalent in statistical genetics, computational biology or similar area with Post Doc and at least 8 years of working experience after post-doc Has a solid background in basic cellular and molecular biology with an understanding of a range of disease areas including neurobiology, gastroenterology, immunology and oncology. Exposure to a wide variety of therapeutic areas such as neuroscience, gastroenterology and oncology is a plus. Fluent in the use of R, Bioconductor, Python, and/or other languages commonly used for statistical genetics and computational genomics analysis. Must be expert in utilizing of various types of human genetic datasets (e.g. GWAS, CNVs, Rare variants, etc.) and has hands on experience in using public human genetics and epigenetics databases. Must be expert in statistical genetics with solid understanding in frequentist or Bayesian inference, Mendelian randomization and polygenetic risk score calculation. Must be expert in sequencing data analysis such as RNAseq, DNAseq, scRNA-seq, etc. Must have a proven track record in the analysis of large OMICS data Is able to develop creative methods for integration of human genetic, epigenetic, gene and protein expression data Must be expert and able to apply advanced machine learning methods such as Hidden Markov Chain, Elastic net, neural nets and deep learning algorithms. Must be able to apply methods of unsupervised machine learning algorithms such as WGCNA, K-means, Hierarchical, DBSCAN, and/or Spectral clustering Must be able to apply methods of dimensionality reduction algorithms such as Non-negative Matrix Factorization (NMF), Principal Component Analysis (PCA), Independent Component Analysis (ICA), Manifold Learning and similar techniques. Driving results is essential. Need to be able to motivate individuals in a cross-functional, matrixed organization and project team setting, to achieve and exceed goals by establishing accountabilities, clarifying performance expectations, agreeing to high standards and measures, monitoring and reviewing performance, and providing timely and relevant feedback. Demonstrated strategic thinker with an ability to create and drive a shared understanding of a long-term vision. Planning, priority setting, and time management are essential. Accountability – takes responsibility for his or her own performance and accepts full ownership of issues, problems, and opportunities, regardless of the source. Comfort with initiating analyses without always having a clear direction planned in advance Demonstrated creativity and innovation, including ability for divergent thinking and the propensity to question to traditional methods, processes, and products, as well as build on others ideas. Excellent communication, interpersonal sensitivity, and negotiating skills PHYSICAL DEMANDS: Carrying, handling, and reaching for objects up to 25lbs Able to work in a lab environment TRAVEL REQUIREMENTS: Up to 20 % travel, both domestic and internally may be required

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Associate Director, Gastroenterology Computational Biology

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Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Computational Biology, Gastroenterology, in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Gastroenterology Computational Biology, working on the Computational Biology team, you will be empowered to set strategic direction, develop tactical plans, motivate, develop and lead teams to execute projects effectively POSITION OBJECTIVES: The Associate Director, Gastroenterology Computational Biology will be part of a team focused on computational biology support of discovery research and translational science. S/he will lead a group of three (3) experts in computational biology and bioinformatics to support Takeda’s discovery and development projects in gastroenterology area, focusing on generating insights from big data for reverse and forward translation in gastroenterology and microbiome. The Associate Director will apply expertise in computational biology and genomics to analyze molecular profiling and phenotype data for the identification and characterization of genes, networks and pathways involved in normal and perturbed physiology. This information will be used to understand the molecular basis of disease pathology and the mechanism of action of drugs, and ultimately be used for selection and progression of drug targets and assets. POSITION ACCOUNTABILITIES: Sets strategic direction, develop tactical plans, motivates, develops and leads team to execute projects effectively Performs computational analysis of RNA-seq, other OMICS and real-world data from internal, collaboration and public sources. Applies unsupervised and supervised machine learning and other advanced algorithms to extract novel biologically meaningful information and to support or falsify target hypotheses and support patient and indication selection and biomarker development. Integrates genomics, genetics, epigenetics, proteomics and literature data to strengthen understanding of diseases and treatment perturbations. Interact with the external scientific community to bring cutting-edge computational methods to bear on drug development. Provides analysis and interpretation of data, specifically for the selection of new drug targets and indications Writes study reports and presents data effectively in all settings and with participants of all levels of the organization. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: PhD or equivalent in computational biology, bioinformatics or similar area with Post Doc and at least 8 years of working experience after post-doc Excellent communication, interpersonal sensitivity, and negotiating skills. Being able to effectively collaborate with key stake holders to serve projects’ needs. Has a solid background in basic cellular and molecular biology with an understanding of a range of disease areas in gastroenterology such as liver fibrosis, IBD and motility disorders, microbiome dysbiosis and immunology. Exposure to a wide variety of therapeutic areas such as neuroscience, gastroenterology and oncology is a plus. Fluent in the use of R (Bioconductor), Python, and/or other languages commonly used for computational biology analysis. Must be expert in applying major bioinformatics tools such as OmicsSoft, IPA, etc. Must be expert in utilizing of various types of human genetic datasets (e.g. GWAS, CNVs, Rare variants, etc.) and has hands on experience in using public human genetics and epigenetics databases. Must be expert in sequencing data analysis such as RNAseq, DNAseq, scRNA-seq, etc. Must be an expert in microbiome informatics and analysis of 16S, metagenomics, metatranscriptomics, meta-metabolomics and metaproteomics data Is able to develop creative methods for integration of human genetic, epigenetic, gene and protein expression data Must be expert and able to apply advanced machine learning methods such as Hidden Markov Chain, Support Vector Machines, neural nets and deep learning algorithms. Must be able to apply methods of unsupervised machine learning algorithms such as WGCNA, K-means, Hierarchical, DBSCAN, and/or Spectral clustering Must be able to apply methods of dimensionality reduction algorithms such as Non-negative Matrix Factorization (NMF), Principal Component Analysis (PCA), Independent Component Analysis (ICA), Manifold Learning and similar techniques. Must be familiar with network modeling algorithms Familiarity with text mining algorithms is a plus Driving results is essential. Need to be able to motivate individuals in a cross-functional, matrixed organization and project team setting, to achieve and exceed goals by establishing accountabilities, clarifying performance expectations, agreeing to high standards and measures, monitoring and reviewing performance, and providing timely and relevant feedback. Demonstrated strategic thinker with an ability to create and drive a shared understanding of a long-term vision. Planning, priority setting, and time management are essential. Accountability – takes responsibility for his or her own performance and accepts full ownership of issues, problems, and opportunities, regardless of the source. Comfort with initiating analyses without always having a clear direction planned in advance. Demonstrated creativity and innovation, including ability for divergent thinking and the propensity to question to traditional methods, processes, and products, as well as build on others ideas. PHYSICAL DEMANDS: Carrying, handling and reaching for objects up to 25 lbs. Able to work in a lab environment

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Director Pharmacovigilance Compliance

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Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Medical Director, Head of Medical Review in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director working on the Global Compliance team, you will be empowered to Innovate and Collaborate. A typical day will include: OBJECTIVE: Inter-acting across R&D, the incumbent will serve as the primary interface within Global PV accountable for establishing, reviewing and coordinating the Global PV compliance strategy with the support of the Head, Global Patient Safety Evaluation (GPSE) Global PV Compliance, Standards and Training and Business Partners Relations. The incumbent will coordinate and work alongside associates accountable for PV compliance strategy worldwide including the US, EU and Japan territories. Principal responsibilities include: Ensuring the compliance activities related to PV inspection/audit readiness for Global PV, coordinating with the US, EU and Japan Compliance leads and partnering with QA to determine internal PV audit areas of focus. Ensuring the oversight of the coordination of PV activities, PV SMEs, and PV deliverables during inspections and audits in coordination with the Head, PV EU PV and Affiliate Compliance, EU QPPV and Head, Compliance, Japan PV as applicable Develop and propose recommendations based on findings from external and internal inspections and audits worldwide to focus GPSE global Compliance more towards preventive actions to sustain our culture of “zero tolerance for late cases”(except for Japan and EU/EEA territories). Collaborating with QA to ensure timely audit and inspection responses for the PV function and appropriate ownership of corrective and preventative action plans (CAPAs) by PV subject matter experts (SMEs) worldwide (except for Japan and EU territories). Collaborating with the Global PV functions to ensure compliance tracking processes and inspections and audit procedures/processes are in place that reflect alignment with various regulatory authorities’ regulations worldwide Ensuring that adequate processes are in place to maintain current knowledge of and adherence to Compliance and relevant PV regulations, including evolving changes in the regulations that may impact compliance. Participating in talent management strategies such as annual reviews, performance management, succession planning and employee development and retention. ACCOUNTABILITIES: Lead the global pharmacovigilance compliance group. Compliance Leads the development of PV compliance programs and quality tools to enhance global PV quality and adherence to SOPs and regulations audits in coordination with the Head, EU PV and Affiliate Compliance and Head, Compliance, Japan and US PV as applicable. Coordinates and collaborates with EU, Japan and US Compliance to ensure Harmonized Global PV compliance processes Support for inspections at LOC sites execution of PV focused and related inspection/audit support globally. In conjunction with applicable Quality Assurance groups, ensure PV regulatory inspection and internal audit readiness for dedicated PV or GCP inspections/audits globally focused. Ensures that PV Compliance data is readily available for inspections and audit purposes. Ensures that all Global PV inspection and audit issues and findings are addressed adequately. Ensure appropriate identification of CAPA stakeholders owners within PV. Serve as the primary link to QA for escalation of PV CAPA compliance. Designs and implements appropriate mechanisms for maintaining and communicating compliance information across GPSE departments and R&D. Collaborates with QA and all relevant PV functions in the development and management of CAPA including assessment of root cause and establishment of timeframes. Directs and manages execution of compliance activities as defined in a PV quality plan including maintenance, collection, compilation and regular assessment of adequate PV compliance metrics related but not limited to expedited and periodic PV regulatory reporting to relevant regulatory authorities for case processing and aggregate safety reporting, and their timely and adequate distribution to LOCs and PV business partners. Develops and implements PV systems in compliance with PV regulatory requirements worldwide in collaboration with the GPSE Global PV Standards Collaborates with the GPSE Training group in the development of training strategies to ensure that GPSE processes meet PV compliance regulatory requirements worldwide. Escalates issues / problems related to PV compliance to senior management timely and as needed. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS Bachelors Required. Advance degree preferred. Minimum 10 years pharmaceutical or health care related industry experience required. Minimum 5 years PV experience with 2 years of additional experience with participation in pharmacovigilance and/or GCP audits/inspections Significant pharmaceutical or health care related industry experience required. Must have proven experience in global PV environment with additional demonstrable experience in leading support of pharmacovigilance and/or GCP audits/inspections In depth knowledge and comprehension of global pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions. Familiarity with inspections and audit procedures Works strategically to realise organizational goals Critical thinking and decision-making skills. Exercise independent judgment. Understanding Takeda business needs with global business perspective and professional attitude. Demonstrate integrity Motivate and empower others Work productively in a high-pressure environment Ability to identify proactively and anticipate risk of non-compliance in a complex environment Knowledge of compliance international Regulations and ICH environment foundations Good analytical/judgment capabilities to understand/analyze/synthesize and communicate Project Management abilities Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives Able to manage both time and priority constraints and to manage multiple priorities simultaneously Attention to details, computer literacy, knowledge of safety database Take initiative and autonomous action Able to lead teleconferences and meetings Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills TRAVEL REQUIREMENTS: Some domestic and international may be required on an infrequent basis

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Associate Medical Director, Translational Sciences

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OBJECTIVES: The Associate Medical Director will be joining the Takeda O-DDU Translational Sciences group with the objective of developing enhanced knowledge of the translational process of drug development, with practical working experience at the interface between discovery and development. This will be achieved through a focus on: (1) customized on-the-job training involving the development process as assets grow through discovery and transition into development; (2) priority participation in the Drug Development Curriculum pending renewal of the program for fall 2019 (3) focused leadership development and mentoring from both oncology discovery and development. The position will begin in discovery with a focus to the translational interface between pre-clinical studies moving into early clinical development. ACCOUNTABILITIES: Working on projects at the interface of discovery and development The individual will initially be based in the discovery translational sciences team but will work on projects moving towards the GPT structure involving clinical development, with planned opportunities to engage with development initiatives. The participant will be working with the Supervisor who is assigned from the relevant department to oversee and guide the work. This will initially be structured within the Translational Sciences team. Range of accountabilities in Translational Sciences can include a focus on biomarkers, PK/PD strategy, clinical mechanisms of action, enabling solutions, interfacing with bioinformatics and genomics pre-clinical and clinical data, and working in a matrix, cross-functional team with other line-functions across research and development in the GPT model including Clinical Development, Biostatistics, Regulatory, Clinical Operations, Project Management, and Commercial stakeholders. Participating in the Drug Development Curriculum The individual will have priority focus for participation in the Drug Development Curriculum beginning fall 2019, pending the decision to renew the course. The course entails participation in weekly/bi-weekly seminars and additional individual work with literature (reading and critical analysis). Working with Discovery and Development Mentors Discovery and Development Mentors will be assigned, allowing the individual to benefit from personalized coaching and mentorship from senior leaders able to provide feedback and expertise relevant to the translational interface between these departments. The participant is expected to establish and maintain a regular working relationship with mentors. The individual will also be offered the opportunity to participate in targeted development opportunities. The schedule for these will be agreed upon at the time of job commencement and will focus on combining mentoring/leadership as well as support for the transition to industry along with developing an industry-focused knowledge base focused on both discovery/pre-clinical/translational activities and early clinical development activities. Ongoing evaluation with individual on meeting career goals and development opportunities within discovery-development interface. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: MD or internationally recognized equivalent, board certified (pr internationally recognized equivalent) in internal medicine or a subspecialty Established record of research accomplishments (PhD or equivalent degree, list of publications, grants, research awards etc) Excellent oral and written communication skills, including writing, reviewing and editing scientific documents Superior interpersonal skills, diplomacy and positive influencing abilities Ability to work and drive decision-making within a multi-disciplinary, multi-regional, matrix teams Good fit with Takeda core values and leadership principles Right attitude (agile, curious, open-minded, “can-do” mindset) Superior therapeutic area knowledge and solid understanding of emerging research in designated therapeutic area (if applicable) LICENSES/CERTIFICATIONS: MD PhD (or internationally recognized equivalent) TRAVEL REQUIREMENTS: Ability to drive to or fly to various meetings or R&D sites including overnight trips Ability to spend longer period of time at a different R&D site (weeks or several months)

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Associate Director - In Vitro Pharmacology

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Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, In Vitro Pharmacology, in our San Diego, California office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, In Vitro Pharmacology, working on the CNS Drug Discovery Team, you will be empowered to contribute to development of new concepts in Neuroscience to aid in early CNS portfolio. OBJECTIVE: Individual independently determines novel methods and procedures for in vitro pharmacology study design according to project objectives; assists in formulating research goals; contributes to the development of new principles and concepts; and ensures the quality of in vitro assay data used to support CNS projects. He/she will supervise the daily activities of scientific staff, and work closely with scientists from other departments. The colleague is recognized as an expert and leader in CNS Drug Discovery and in vitro cellular assays internally and often externally. Proposes, initiates, and conducts research projects or research programs in collaboration with the Director of CNS Biology and the CNS Franchise. Supports the entire CNS Research effort and functions with considerable freedom. exercise independent judgment; handles multiple tasks simultaneously. ACCOUNTABILITIES: Assumes a scientific as well as a management leadership role for a research program Supervises and develops direct reports to their full scientific and career potential Designs, develops, and validates relevant cellular models for CNS programs Assumes team member representation at project teams Contributes to development of new concepts in Neuroscience to aid in early CNS portfolio Plans, implements and manages internal and external non-clinical activities and interactions to deliver key experimental studies to support CNS Research goals Identifies and applies novel technology and expertise Presents results both written and verbal and delivers completed reports within a multidisciplinary team environment Closely collaborate/interact with other scientists from global Takeda R&D Diligently performs assigned lab and company responsibilities Maintains concise, accurate, and comprehensible written records as per Takeda California policy EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Ph. D. with thesis and at least 8 years of research experience (Postdoctoral position may serve as experience) Demonstrated technical proficiency. Extensive, in-depth expertise in CNS pharmacology based assay development and screening including Cellular Assays. Has 5 years of drug discovery experience, preferably including experience in managing a cross-functional research group in the pharmaceutical/biotech industry Has demonstrated independent thought/creativity in science and success in coordinating and executing research to further corporate goals Strong background in CNS research and development, with thorough understanding of mechanism of action of targeted therapies (experience with psychiatric diseases preferred) Experience using a broad range of technologies; including cellular assay systems, and molecular techniques. Willingness to work in a dynamic and changing environment Demonstrated supervisory experience and project management skills High level of motivation and a proven record of accomplishment Excellent communication and interpersonal skills PHYSICAL DEMANDS: Manual dexterity required to operate office equipment (i.e. computers, phones, etc.). Carrying, handling and reaching for objects (up to 25 lbs.) Office, lab and vivarium environment TRAVEL REQUIREMENTS: Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required Requires approximately 5 % travel

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Medical Director, Global Patient Safety Evaluation

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Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Medical Director, Pharmacovigilance in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Medical Director working on the Pharmacovigilance team, you will be empowered to Innovate and Strategize. A typical day will include: POSITION OBJECTIVES: Support developmental programs, including both early and late stage development as required. Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly as appropriate. Supporting Therapeutic Lead Line management responsibilities for junior physicians and/or scientists Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs POSITION ACCOUNTABILITIES: Expectation of GSL role for compound(s) both in development and marketed in close association with the TAL. Company wide safety expert for his/her compound responsibilities Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for ‘own’ compounds with input for other compounds as needed. Serving in a leadership capacity for complex and strategically important programs Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc Training and mentoring of Pharmacovigilance Physicians and Specialists Perform activities required to serve as Global PV physician: Review and oversight of safety data, both non-clinical and clinical Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities Interactions with external experts and regulatory agencies and partner/co-development companies Review of safety data and participate in dose escalation decisions Authorship and sign off of Safety Monitoring Plan/Risk Management Plan Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators Direct the set up of safety procedures and development of safety exchange agreements for co-development projects Maintain professional knowledge and accreditation by active participation in continuing medical education activities EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS: Qualified physician (Licence, e.g. GMC registered, preferred) Knowledge of principles of epidemiology and statistics. Critical thinking and analytical skills and ability to make high level decisions Excellent oral and written communication skills including ability to present to large internal/external groups Good level of computer literacy with Microsoft applications Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development 2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine TRAVEL REQUIREMENTS: Estimated 5-10 times per year including international travel

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Director, Communications Business Partner to Global Human Resources

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Job Description Takeda is a global pharmaceutical leader with more than 30,000 professionals working together across more than 70 countries. We have an unwavering dedication to put people first and we live our values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. We are united by our more than 230-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Takeda is in the process of creating a more robust global Corporate Communications presence. As part of this, the company seeks to appoint a highly experienced and well-rounded communicator to the role of Director, Communications Business Partner to Global HR. This is a director-level position reporting directly to the head of Global Internal Communications. ACCOUNTABILITIES: Strategy Development Demonstrate a solid understanding of Takeda and HR communications landscapes to develop and drive the overall HR Function communications strategy to support the overall success of the HR function priorities within Takeda and to realize the people brand both internally and externally Utilize understanding of the connection between Takeda’s strategy, the Global HR strategy and the internal communication strategy to help drive understanding across the business through global HR communications Identify HR Function communication needs and priorities, provide direction and focus on high-value work with a focus on driving performance and employee engagement Identify highest-impact opportunities for Communications’ support. Develop and execute communications plan for all Global HR led annual events; and coordinate with relevant communications teams to ensure alignment with global positioning Advise and counsel cross-functional teams to ensure clarity on short- and long-term communications strategies both within the HR Function and cross-functional stakeholders Reset and adjust HR Communications strategy based on continuous measurement and changes in business needs Ensure alignment with other local, regional and global communications colleagues to bring the people brand to life and support HR communications objectives Communication Planning & Execution Create, manage and execute on HR communications plans for all initiatives that clearly demonstrate the link between desired business outcome and function communications activities Provide Executive communications support to the Chief Human Resources Officer (CHRO). Increase visibility and impact of CHRO and HR leadership communications through key events and channels globally and locally (executive notes, key message, presentation material, organize town halls) Provide expert guidance on the communication of key projects and initiatives (e.g. Employee Value Proposition, diversity & inclusion, employee engagement, learning and development, performance and reward and employee life-cycle) that form the global HR strategy Serve as expert and contributor of HR messaging to global editorial and content, acting as primary liaison between Global HR and Global Internal Communications in developing and reviewing key HR / people messages for the CHRO Design compelling global HR project and non-project communications, crafting an engaging approach to ensure key HR / people messages are understood Partner with HR to lead change communication to support Takeda’s Global transformation journey Support functional and organizational changes and counsel, develop, and support the execution of change program communications relating to HR Routinely measure and analyze how effectively HR’s portfolio of project and non-project activities are being communicated across global and local channels, making recommendations where relevant Stakeholder Management Build relationships, counsel and advise on cross-BU/Function initiatives in close collaboration with Subject Matter Experts/Functions Act as a trusted resource and develop strong relationships with colleagues at all levels Develop relationships and credibility with teams in other areas of Takeda, and leads communications and HR colleagues to achieve consensus and results Business Acumen Build a deep understanding of HR Function, Global Internal Communications, and relevant departments’ objectives and landscape Continually seek information, including HR industry trends (e.g. employee engagement) and regulatory changes (e.g. changes in employee law, works councils, unions) and input into how communication can help achieve business objectives Serve as the technical expert in the HR area of communications Continuous Improvement Engage in communications learning networks to circulate Communications best practices amongst the Global Internal Communications and business partner communications teams Develop and/or share best practice guidelines to help HR colleagues hone their communications skills SKILLS AND COMPETENCIES: Strategic and Engaging Communications Outstanding communications consulting skills and proven ability to help internal partners/stakeholders address strategic opportunities and solve problems A skilled communications strategy mindset continuously focused on desired and measurable business outcomes Superb communications content planning and delivery in English, Japanese a plus Strong communication and presentation skills consistently exhibit professional maturity, confidence and competence Experience in external communication with various stakeholders Interpersonal Influence Ability to engage with senior leaders and provide strategic counsel and feedback Strong interpersonal and partnering skills, and the ability to build strong and sustainable relationships with and influence internal and external stakeholders at all levels and functions of the organization Business Acumen Passionate about and knowledgeable of the pharmaceutical and/or life sciences sector Global understanding, acumen and the knowledge of how to work in an international structure and varied cultures and how to communicate to make an impact in diverse workforce Knowledge of organizational and people behavior, and how to raise employee engagement and drive change through communications Project management Solid organizational and time management skills with proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion EXPERIENCE: Significant experience (minimum seven to ten years) in corporate communications to meet communications objectives and increase employee levels of engagement and drive behavior change Minimum five years’ experience in a senior communications role, healthcare or pharmaceutical industry strongly desired but not essential, preferably supporting HR communications in multinational companies Experience developing, executing and managing communications strategies within complex organizations with multiple cultures/ in transformative stage undergoing change and providing strategic communications counsel to senior executives Experience in building and utilizing social media strategies, employment brand and reputation in local and global talent markets Managerial experience in corporate communications, including managing a number of programs/projects simultaneously and oversight of multiple communications platforms and channels Proven record of building and maintaining excellent stakeholder relationships – within teams, across the business, with senior leaders and external agencies. Including ability to successfully collaborate with others to identify needs, provide guidance, and create and communicate solutions Lateral thinker who’s able to use creative ways to address business needs Experience and understanding of multi-cultural, multi-country/region businesses is preferred A pragmatic and flexible approach to personal time management given calls/meetings with your stakeholders may take place in different time zones to your own Able to seamlessly work lead strategic planning through to execution and delivery PHYSICAL DEMANDS: Manual dexterity required to operate office equipment (i.e. computers, phones, etc.) Carrying, handling and reaching for objects Ability to sit or stand for long periods of time while traveling

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Associate Scientific Director, Pharmaceutical Sciences Program Management

new2 days ago
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Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Scientific Director, Pharmaceutical Sciences Program Management in our Cambridge office. As an Associate Scientific Director working on the Pharma Sci (PS) team, you will be empowered to be a key player in the Pharmaceutical Sciences division of Takeda and work to develop solutions for Takedas critical project needs, and a typical day will include: POSITION OBJECTIVES: Expected to engage others by inspiring commitment through leadership and clarity of vision. Lead by influencing through relationships, mobilize high performance through targeted development, anticipate the team’s future needs and help lead the Global CMC Team (GCT) activities with those needs. Also contribute to Global Project Team (GPT) activities as Pharm Sci representative in defining and executing GPT strategy toward successful product launch and product value maximization through agreed LCM activities. As technical project lead (TPL) for GCT, ensuring advancement and transparency for programs to GPT Lead (GPL), PS management and other key stakeholders. Develop and execute CMC development plan with other GCT members Manages day to day operations and risks/issues associated with assigned program Leads and influences Functional and Divisional initiatives, and contributes to corporate/global initiatives. Exemplifies and is recognized for expertise in, and contributions to, Functional and Divisional team leadership and communication. POSITION ACCOUNTABILITIES: Technical Project Leadership: Leads multifunctional team in a metrics environment and effectively influence the performance of team members without authority Manages and oversees the timely communication and transparency of GCT activity to GPL, PS management and other key stakeholders Identifies, mitigates and communicates program risks to relevant stakeholders. Represents PS on GPT while providing strategy and accountability for PS deliverables. In doing so, accountable for all aspects of program management including budgets, timeline development, risk assessment etc. Cultivates a broad network of relationships throughout Takeda, with affiliates and alliance partners, to advance and promote understanding of PS mission/job purpose and capability. Leads/participates as functional expert in divisional and cross-divisional initiatives. Technical Acumen: Identifies, evaluates, develops, recommends and/or negotiates novel solutions to meet assigned program needs. Demonstrates humility and approachability in encouraging others to challenge ideas and openly raise issues. Lead/contribute to enhance individual skills of pharmaceutical product development. Lead/contribute in developing the capabilities of the department by identifying opportunities and anticipating changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business, and proposing innovative solutions to address them. Inspires commitment through a wide range of communication channels (meetings, writing, and presentations). Collaborate with other members in the department to ensures that operational standards and practices within the function meet state-of-the-art industry expectations. EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS: Education: BS 15 years experience, or MS 12 years experience, or PhD 10 years experience Technical Skills/Competencies: Ability to propose and influence development that results in a commercially viable product. Must have the maturity to utilize scientific and technical knowledge to provide unique business solutions. Experience must be in a scientific discipline with expert knowledge across the full spectrum of PS related pharmaceutical development. Must demonstrate knowledge of several allied fields, such as biologics, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance, DMPK, Pharmacology and/or Toxicology. Extensive knowledge of current Good Manufacturing Practices (cGMP), ICH Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies. Must have experience in global regulatory submission requirements and processes Program Management Skills/Competencies: Proficient in the application of project management knowledge, skills, tools, and techniques for complex multidisciplinary programs and initiatives. Leadership - develops and uses knowledge and interpersonal skills to influence and guide internal and external stakeholders towards the accomplishment of program, divisional and corporate goals and objectives; adapts well to different personalities and manages others on the team in a respectful manner. Risk Management – ability to identify/solve technical, budgetary, and schedule risks to multiple programs and propose appropriate risk response strategies. Ability to identify gaps in PS technology/trends and influence change/improvements to affected areas/processes. Communication – ability to expresses one’s self clearly and concisely to key stakeholders; documents issues and/or concerns concisely and comprehensively; adjusts style, language and/or terminology appropriate for the audience. Can represent PS viewpoint at corporate and industry level. Resource Management – Ability to anticipate and manage internal and external resource needs (people, information, technologies, time, and capital). PHYSICAL DEMANDS: Manual dexterity required to operate office equipment (i.e. computers, phones, etc.). Carrying, handling and reaching for objects. Ability to sit or stand for long periods of time. TRAVEL REQUIREMENTS: Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.

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Director Manufacturing

new2 days ago
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Responsible for all direct manufacturing operations associated with commercial GMP production of bulk Drug Substance (DS) and final container Drug Product (DP) of purified recombinant protein(s) for worldwide distribution and sales. Responsible for a commercial chemical modification suite. Direct departments include Industrial Cell Culture, Industrial Purification, Chemical Modification, Aseptic Filling, and Final Packaging operations. Accountable for delivering quality product consistent to an annual budget, volumes, yields, and manufacturing plan. Responsible for close and consistent interaction with the Site Lead and functional groups at the facility, as well as within the Network (Bio OpU) and Corporation. Plan, organize, integrate and review staff resources with production requirements to successfully meet current and future production targets. Direct continuous improvement strategies to meet existing and planned commitments. Ensures budgets, schedules and performance requirements are met. Essential Duties Responsibilities Responsible for the outgoing quality, safety and efficacy of all finished product, compliance with all applicable specifications, Standard Operating Procedures, FDA regulations (GMP's) and New Drug Applications. Ensures budgets, schedules, capacity, and performance requirements are met. Improve product quality and cost and reduce customer complaints through a proactive program that includes interaction with internal and external suppliers. Utilize collected data from customers to enhance perceived product quality. Ensure reliable operations through life cycle management of equipment, facilities, and processes. Adheres to all environmental, health and safety SOP's, equipment, policies and procedures, including any department specific requirements. Propose and devise strategies for improvements through coordination with global process alignment teams and from the data gathered in manufacturing operations. Responsible for resolving complex problems where analysis of situations or data requires an in-depth evaluation of multiple factors. Must execute judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Regularly interacts with senior management or executive levels on matters concerning several functional areas, division, andor customers. Establish and maintain an environment that stresses and encourages teamwork. May perform other duties as assigned. Qualifications Ability to manage activities of departments through subordinate managers who exercise full supervision in terms of cost, methods, and employees. Ability to interpret and analyze statistical data and financial reports, understand and resolve technical difficulties, interface with internal engineeringtechnical experts and external technical representatives, and manage multiple priorities in a manufacturing environment setting. Intermediate software application skills required. Passion for Improving Lives. Must be able to put our patients at the center of everything we do. Quest for Innovation. Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations. Inspired Teams environment. Must be able to thrive in diverse high performing teams. Engaged with the World Around Us. Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world. Education andor Experience Bachelor's degree in a technical discipline is required. Master's Degree or MBA preferred with 8 to 10 years of manufacturing experience required. This role requires a minimum of 8 years leadership experience. Strong interpersonal, problem solving, and communication skills are required. Operational excellence skills (i.e. Six Sigma certification and lean) and supervisory skills would be considered a plus. Working Environment Normal office environment. Will have interaction with other people. Pace may be fast and job completion demands may be high. Travel up to 10. Physical Demand This is a sedentary position. Position requires the ability to gown to enter and observe the work areas on a regular basis. Department Manufacturing

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Manufacturing Lead

new2 days ago
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Takeda is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal Internal Medicine Endocrine and Hereditary Angioedema a growing franchise in Oncology and an emerging, innovative pipeline in Ophthalmics. Our employees come to work every day with a shared mission to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.The position will support the development of a new, state-of-the-art plasma processing facility that will bring Takeda additional cGMP capacity for fractionation, purification, filling, and packaging for its biologic medications.The SR Manufacturing Technician position is responsible for executing commissioning and validation activities in addition to other facility start-up support activities, as needed, then the role will transition to an operational manufacturing shift lead position where it is expected that the incumbent conducts all manufacturing department processes and assists the supervisor as needed. In addition to making routine revisions to documents, this position may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform moderate trouble shooting tasks and will assist in the execution of technical transfer activities. This position has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills. Drive schedule adherence on the Manufacturing floor.Coordinate activities across the shift.Escalate issues or decision effectively.Containment of issues as they arise on shift.Involved in hands-on execution of manufacturing operations.Assist supervisor as needed on shift.Accountability for results.Support a perfect equipment culture, by assisting maintenance team during implementation of programs such as Total Preventive Maintenance (TPM), equipment reliability, Preventive Maintenance (PM) and Predictive Maintenance (PdM) programs, etc. Contribute toward authoring SOPs and Job aids, associated to manufacturing processes.Support process technical transfer activity execution.Support the implementation of Kanban and 5S systems to assist from CQV to Full production environment.Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS) through all manufacturing associates and production engineers. Understand and follow Job Hazard Analysis (JHA) packets.Train and explain process to others and ensure execution of processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply.22. Stay current with biopharmaceutical industry best practices and technologies.23. May perform other duties as assigned.RequirementsEducation andor ExperienceMust be able to read and follow detailed writtenelectronic instructions and have good verbalwritten communication skills.In depth process understanding of primary work areas and manufacturing techniques (e.g. Buffer preparation, fractionation, purification, fill, finish).Troubleshoot and identify atypical processing conditions and how to respond to them.Basic Knowledge of Delta V, PLC based process control systems. Human Machine Interface (HMI) configuration.Basic Knowledge of instrumentation and mechanical equipment such as controllers, indicators, control valves, PLC, analyzers, sensors, pumps etc.Understanding of suppliercustomer process streams and interdependencies.Must have customer services and leadership attitude to take ownership of any maintenance related problem.Must be able to read, write and converse in English.Must be able to read and follow detailed written instructions and have good verbalwritten communication skills.Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and US standards of measurement.Must have good interpersonal skills and be able to work effectively and efficiently in a team environment.May require immunization before performing work within the manufacturing area.Must demonstrate importance of working in a regulated environment.Must have the knowledge and ability to use a personal computer, electronic mail systems and navigate and conduct searches on the intranet.Must have and display the following personal attributes Integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.Experience in a regulated productionenvironment desirable Bachelor's degree in science engineering with 1 years of or AA or equivalent and 6 years ofexperience or High School diploma with 8 years ofexperience.Must have working knowledge ofscientific principles. Scientific ortechnical degree preferred. Department Manufacturing

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Reliability Specialist Technician

new2 days ago
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Takeda is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal Internal Medicine Endocrine and Hereditary Angioedema a growing franchise in Oncology and an emerging, innovative pipeline in Ophthalmics. Our employees come to work every day with a shared mission to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.The Reliability Specialist Technician is responsible for monitoring plant equipment with the goals of improving equipment reliability and lowering maintenance costs through the application of predictive maintenance technologies. Investigating failures using root cause analysis, forensic engineering techniques to create a site catalogue of failures. Strict adherence to Standard Operating Procedures (SOPs), cGMPs, and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory.Essential Duties IncludeCollect relevant data and perform predictive maintenance analysis in one or more of the following technologies Vibration Collection, Dynamic Balancing, Oilfluid maintenance, Ultrasonic Analysis, Infrared Thermography, Motor circuit analysis (MCA), Online Vibration MonitoringDevelop the PdM systems and procedures to ensure accurate and repeatable data is collected and analyzed on targeted equipment at appropriate intervals.Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem solving abilities. In addition to the acquisition of advanced PdM certifications which includes obtaining Level II Vibration Analysis certification.Conduct assigned duties with minimal supervisionCoordinate with the Planning group to ensure maintenance requirements are effectively communicated.Perform post repair analysis to verify accuracy of fault identification in order to continuously improve diagnostic skills.Support Maintenance Operations in troubleshooting equipmentsystems using PdM technologies and equipment.Perform necessary work (such as precision drilling and tapping) to install monitoring equipment, vibration mounting pads, transducers, channel boxes, etc.Give presentations as needed to communicate findings.Manage and supervise contractor activities as assignedEnsure accurate documentation of planned and unplanned maintenance activities through adherence to cGDPs.Assist with troubleshooting of process and utility equipment issues including electrical and mechanical systems.Familiarity with Change Control, Site, and Divisional SOPs related to position and department are required.Procedural (JP's, HECP's, JHA's, etc.) revision's as necessary.Strict adherence to EHS guidelines and policies required to ensure compliance to Georgia state, federal EPA, and OSHA regulatory agencies. Possess or have ability to gain knowledge of FDA, OSHA, EHS, EPA, and state of Georgia requirements while ensure strict adherence to these guidelines in all project activities.Maintain a positive, professional, and customer oriented attitude.Communicate concerns related to safe work practices, hostile work environment, sexual harassment, or any other type of employee misconduct directly to the Supervisor, Manager, or Human Resources.Possess very strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills.Possess strong mechanical knowledge of equipment, using PID's, equipment manuals, specifications, SOPs, and be able to use proper judgment when taking corrective actions during equipment malfunctions.Possess or have ability to gain knowledge of NFPA 70E electrical qualifications.Must possess computer skills (Word, Excel, BAS, Scada, Electronic Mail, Intranet) to navigate, conduct searches, and complete on-line forms for purposes of training, performance management, self-service applications, and communication purposes.Education andor experienceAssociates Degree in Engineering or Engineering technology desired but not requiredPrefer 6 to 10 years combination of education, training, and experience in a cGMP related environment.Prefer Electrical licensePrefer experience with PdM technologies and participation in a Mechanical Integrity ProgramMust have the following personal attributesIntegrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.Passion to innovate and drive for solutions.Must display personal accountability for results and integrity.Must display eagerness to learn and continuous self-improvement.Must have uncompromising dedication to quality.Must have relentless focus on rapid and disciplined action.Must have respect for individuals and the diverse contributions of all.Working EnvironmentMay work in cold, wet environment may be exposed to sunlight and heat may be exposed to dust, gases, and fumes may be around moving equipment and machinery may climb up to andor into large processing tanks for cleaning or inspection may be working in areas requiring hearing protection andor other protective equipment (PPE) may work around chemicals such as alcohol, acids, buffers, and celite that may require respiratory protection (PPE).This position requires weekend and holiday work. Overtime may be required. Individual must have the flexibility to work various shifts.May be required to frequently kneel, stand, and walk to inspect, evaluate, andor perform described maintenance activities. Equal Employment OpportunityTakeda is an equal opportunity employer. Takeda evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disabilityhandicap status or any other legally protected characteristic.EEO is the LawEEO is the law - SupplementPay Transparency PolicyReasonable AccommodationsTakeda is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information. Department Operations

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Utilities Operation Technician II

new2 days ago
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Takeda is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal Internal Medicine Endocrine and Hereditary Angioedema a growing franchise in Oncology and an emerging, innovative pipeline in Ophthalmic. Our employees come to work every day with a shared mission to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.This position will support the development of a new, state-of-the-art plasma fractionation facility that will bring Takeda additional capacity for testing, purification, and fill and finish for its biologic medications.The Utilities Operation Technician II is responsible for operate and troubleshoot utilities systems that support manufacturing process areas. Strict adherence to Standard Operating Procedures (SOPs), cGMPs, and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory. Primary responsibilities include ensuring safe and efficient hands-on operation of utilities systems including but not limited to WFI, RO, PA, Alcohol, Boilers, Chillers, Cooling Towers, Wastewater Treatment Plant (WWTP) and related support equipment such as pumps, fans, valves, etc. Perform daily utilities systems operations activities.Ensure accurate documentation of urgent, critical alarms and triages activities through adherence to cGDPs.Perform systems monitoring (watchstanding) and ensure proper response and communication through SOP adherence.Assist with troubleshooting of utilities equipment issues including mechanical, electrical, metrology, or automation as needed.Support equipment IQOQPQValidation startup activities.Support Reliability Centered Maintenance (RCM) activities to include Condition Monitoring and Infrared Technologies.Strict adherence to EHS guidelines and policies required to ensure compliance to Georgia state, federal EPA, and OSHA regulatory agencies.Maintain all mandatory training requirements current, ensuring compliance to site DP's and job performance qualifications.Maintain two-way performance dialogue with your Supervisor to ensure mid, annual, and PDP processes are completed in timely fashion.Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem solving abilities.Maintain a positive, professional, and customer oriented attitude.Communicate concerns related to safe work practices, hostile work environment, sexual harassment, or any other type of employee misconduct directly to the Supervisor, Manager, or Human Resources.May perform other duties as assigned.QualificationsTechnical troubleshooting problem solving skills are a must. Possess or have ability to gain knowledge with respect to the operation and maintenance of various Process Manufacturing systems.Possess or have ability to gain verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess interpersonal skills.Possess mechanical knowledge of equipment, using PID's, equipment manuals, specifications, SOPs, and be able to use proper judgment when taking corrective actions during equipment malfunctions.Possess or have ability to gain knowledge of FDA, OSHA, EHS, EPA, and state of Georgia requirements.Must have the following personal attributesIntegrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.Passion to innovate and drive for solutions.Must display personal accountability for results and integrity.Must display eagerness to learn and continuous self-improvementMust have uncompromising dedication to quality.Must have relentless focus on rapid and disciplined actionMust have respect for individuals and the diverse contributions of all.EducationHigh School Diploma or GED required. 2 years of experienceWorking EnvironmentMay work in cold, wet environment.May be exposed to sunlight and heat.May be exposed to dust, gases, and fumes.May be around moving equipment and machinery.May climb up to andor into large processing tanks for cleaning or inspection.May be working in areas requiring hearing protection andor other protective equipment (PPE).May work around chemicals such as alcohol, acids, buffers, and may require respiratory protection (PPE)May be required to frequently kneel, stand, and walk to inspect, evaluate, andor perform described maintenance activities Department Operations

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Senior Manufacturing Support Engineer

new2 days ago
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Primary Role The individual will be expected to monitor and provide support for downstream purification operations. Responsibilities will include monitoring of the process and containment of process failures and deviations that occur during purification processes and coordination and implementation of associated corrective and preventative actions. The individual will also participate and function as TS lead on technology transfer and process improvement teams. This individual will function as the technical lead for the downstream Technical Services group. Responsibilities40Floor Support - Troubleshoot process issues monitor and evaluate process operation data for upstream or downstream operations including but not limited to cell culture roller bottlebioreactor and capture step operations, filtration (NF, UFDF) unit operations, chromatography column performanceintegrity and drug substance formulationbottling. 20Process Monitoring - A key part of this role will be assisting with continued development of the process monitoring capabilities for manufacturing operations for purification operations. This will include helping to work on developing a real time multivariate process monitoring system for purification operations.20Continuous Improvement - Work with manufacturing staff to identify opportunities to improve the consistency and robustness of process operations. Provide leadership in the development of mfg. training initiatives. 10Tech Transfer - Support the transfer of phase I, IIIII clinical processes into the existing GMP manufacturing facilities as define by Tech Transfer group10Quality System Support - Lead consistent and well documented response to process operations events to support investigations, deviation closure as well assistance to change controlCAPA as appropriate.Education and Experience RequirementsBS in ChemicalBiochemical Engineering or Chemistry with 8 to 12 years or MS with 6 to 10 years of process development manufacturing experience for purification of recombinant proteins. Hands-on experience with large-scale protein purification manufacturing processes, preferably with commercial or licensed products. A working familiarity with single use process systems, automation (local and distributed control systems), and sterileaseptic processing in a cGMP environment. A detailed knowledge of the science and technology for the major unit operations associated with manufacturing operations to include fluid transfer, filtration, chromatography, CIPSIP, and UFDF processes. Experience with troubleshooting problem solving and risk assessment mitigation. Demonstrated experience making science based andor data-driven recommendations for manufacturing operations. Experience with process technology transfers. Candidate must have purification manufacturing andor process development experience, preferably with recombinant proteins. Candidate must have working knowledge of cGMPs and statistical analysis methods. Candidate should be experienced with supporting inspections by health authorities. A familiarity with software based statistical analysis programs as well as training in quality improvement techniques, operational excellence tools and project management is a plus. As an active participant on multiple cross-functional teams, the candidate must also demonstrate excellent written and verbal communication skills.Candidate will make complex decisions regarding product impact on a regular basis. Candidate will also be required to assess the requirements of processes against the capabilities of existing equipmentfacilities interacting with cross-functional team members for review and resolution. Candidate must be able to work in a dynamic environment, be able to set and balance priorities, and serve as a change agent.The candidate will Develop solutions to complex problems which require the regular use of ingenuity and innovation. Ensures solutions are consistent with organization objectives. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise. Contributes to the development of new concepts, techniques, and standards. Considered expert in field within the organization. Work is performed without appreciable direction. Exercises considerable latitude in determining objectives and approaches to assignment. Serves as consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, plans, and objectives.The candidate will work under general direction and participate in determining objectives of assignment plan schedules and arrange own activities in accomplishing objectives to meet customer needs. Department Manufacturing

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WWTP, Sr. Utilities Technician

new2 days ago
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Takeda is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal Internal Medicine Endocrine and Hereditary Angioedema a growing franchise in Oncology and an emerging, innovative pipeline in Ophthalmic. Our employees come to work every day with a shared mission to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.The Sr.WWTP Utility Operator will work for the WWTP operations for utilities at the Covington Facility. This includes day-to-day daily operational support preventive and corrective maintenance, shutdown scheduling and vendor management. This position will be responsible for WWTP performance, permit adherence and support process improvements initiatives. The WWTP Utility Sr.Operator will perform daily activities of Utilities WWTP Operations.The WWTP Utility Sr Operator will also be available on-call at all times to respond to plant-wide emergencies and WWTP needs.Perform daily monitoring i.e. rounds, datasample collections, and Maintain daily communication with supervisors and CUB personnel. Support all commissioning activities and automation activities. Must ensure adherence to all WWTP SOPs. Review procedures and update them as necessary. Ensure a safe work environment is maintained through adherence to safety guidelines and policies. Must follow safety rules and ensure compliance with GA state and federal EPA regulation and laws. Specific responsible system repairs, upkeep, maintenance and operations managed within regulating agencies such as OSHA. Ensure continual training staying current with assigned SOPs and other cGMP procedures. Ensure all mandatory training requirements are met, including annual EHS training, GMP refresher training and any applicable licenses training requirements. Maintain an on-going two-way performance dialogue with your supervisor. Demonstrate continuous progress with respect to increasing job knowledge and proficiency in technical understandingproblem solving. Maintain a positive, professional and customer oriented attitude. Communicate any concerns related to safe work practices, hostile work environment, sexual harassment. May perform other duties as assigned.RequirementsEducation andor ExperienceExcellent technical troubleshootingproblem solving skills are a must. Must be knowledgeable with respect to the operation and maintenance of various utility systems including DAF, Centrifuge, Aeration Basins, Blowers, Pumps and others.Possess very strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills. Have a thorough knowledge of WWTP equipment and possess strong mechanical knowledge and skills on WWTP equipment.Have working knowledge of hazardous chemicals and their disposal, OSHA and FDA requirements. Display a positive, professional and customer oriented attitude. Must have the following personal attributes Integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self-service applicationMust have the ability to navigate electronic mail systems and intranet for communication purposes.Must have computer skills (Word, Excel, BAS, Scada systems)Must have passion to innovate and drive for solutions.Must display personal accountability for results and integrity.Must display eagerness to learn and continuously improve.Must have uncompromising dedication to quality.Must have relentless focus on rapid and disciplined action.Must have respect for individuals and the diverse contributions of all.Must have GA Industrial Wastewater Operator license or higher.A degree in Engineering (preferred) or equivalent 8 years of work experience with continuing education in a utilities maintenance environment is required.Working EnvironmentMay work in a cold, wet environment.May be exposed to sunlight and heat.May be exposed to dust, gases, and fumes.May be around moving equipment and machinery.May climb up and into large processing tanks for cleaning or inspection.May be working in a loud area that requires hearing protection and other protective equipment to be worn.May work around chemicals such as alcohol, acids, bases and others.May be required to work or be assigned to a different shift as needed.Must be able to work more than 8 hours a day or 40 hours a workweek as required.This position requires shift, weekend and holiday work. Overtime may be required at times.May be required to work in a confined area as defined by the Environmental, Health, Safety officePossible exposure to coolhot storage conditions. Physical DemandRequires performing activities within the utilities equipment, mechanical work and computer based activities.May be required to lift up to 50 pounds when managing chemicals.May be required to crawl occasionally to visually inspect equipment.May be required to grip and grasp frequently when performing mechanical jobs.May be required to kneel occasionally to visually inspect an equipment.May be required to stand frequently when evaluating equipment.May be required to walk frequently through utilities systems. Department Operations

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Associate Director/Director of Statistics, Oncology

new2 days ago
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Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Statistics in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director working on the Global Statistics team, you will be empowered to innovate, design and build strategies. A typical day will include: POSITION OBJECTIVES: Serves as global statistical expert for major development programs, leading and managing a team of statisticians Oversees all statistics activities for one major clinical program or multiple clinical programs to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions. Independently provides strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study analyses including statistical methodology, interpretations, regulatory submissions and follow up. Establishes and drives therapeutic area(s) program functional strategy for resourcing, processes and standards to maximize efficiency and global data integratability. Participates in functional and cross functional initiatives including process and quality improvements POSITION ACCOUNTABILITIES: Serve as global statistical lead for assigned therapeutic areas or phase of development or CMC/non-clinical activities. Lead and manage team of statisticians supporting cross region studies and programs for identified therapeutic area(s) or phase of development or CMC/non-clinical activities; manages assignments and priorities of team members. Develop and mentor staff by utilizing appropriate internal and external resources to achieve short term and long term strategic functional goals. Promote innovative clinical trial designs and efficient analysis methodologies Play a leadership role in development and completion of major statistics deliverables and milestones in collaboration with other functions. Drive/participate in development and implementation of global systems, processes and standards to maximize quality and efficiency. Leverage standardized analysis methods and reporting standards to maximize global data integratability; identifies best practice for utilization across programs. Provide statistical leadership and support for regulatory meetings, submissions and follow up. Provide or identify internal and external statistical expertise and capacity to support development activities. Collaborate/lead in the development of compound/program-level sourcing/vendor strategies and provide oversight of statistical services, ensuring overall quality. Assess, communicate and propose solutions for internal, external resource and/or quality issues that may impact deliverables/timeline at the program level. Provide input for planning and management of external budgets related to statistical deliverables. Participate/Leads in external professional initiatives and organizations such as ASA, PhRMA, DIA, etc. to identify industry best practice and its applicability in Takeda. EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS: PhD in statistics or biostatistics with at least 7 years of relevant pharmaceutical industry experience or MS in statistics or biostatistics with at least 10 years of relevant pharmaceutical industry experience Experience with at least two NDA/CTDs or other regulatory submissions. Experience representing Statistics function in interactions with regulatory agencies. Advanced knowledge of clinical study designs, analysis methodology and data interpretation. Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function. Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions. Strong statistical programming skills Excellent oral and written communications skills. Specialized statistical expertise in multiple therapeutic areas or development phases. Strong inter-personal and people management skills. Strong project management skills. Strong collaborative skills and ability to work with a cross-functional team. Ability to influence others, without direct hierarchical authority, and affect change across organizational boundaries

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Senior Manager /Associate Director, Program Management - Search & Translational Science

new2 days ago
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Job Description Senior Manager /Associate Director, Program Management - Search & Translational Science Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join our Search & Translational Science team as a Senior Manager /Associate Director, Program Management in Search & Translational Science our Cambridge office. Here, everyone matters and you will be a vital contributor in Rare Disease Therapy Area Unit’s mission The S&TS PM will drive the execution of project plans to advance early development assets from the DDU or external partner to Therapeutic Area Unit (TAU) transition at the first major clinical development decision. This is foremost an operational role to provide program management support to the Translational Science Team, in the following manner: Serves as the operational partner to the Head of S&TS and others within the group to ensure overall alignment and delivery of project results to realize the Rare TAU vision, mission and strategy. The PM works closely together with the Asset Leads within the group, and other TAU members, Drug Discovery Unit (DDU), and other R&D and Commercial functions, to ensure that the medical, scientific and commercial strategy is integrated into a pragmatic operational plan. Optimise the S&TS systems and processes to ensure fit for purpose to deliver on successful & agile delivery of the group’s objectives. Program manages specific assets within the portfolio, ensuring efficient prioritization, and capturing value creation, as well as partnering with Finance to ensure accurate financial reporting ACCOUNTABILITIES: Delivering on S&TS Objectives Responsible for leading the implementation of S&TS strategy into operational plans, defining the overarching goals and KPIs and developing tools to track performance. Leads the risk/issue management process and proactively remediates issues for specific assets they are assigned. Define the operational development plans for pipeline assets and critical path activities to the next inflection point identifying creative solutions and new modus operandi to operational challenges. Project Managing the execution of the development plans. To include budgets, timelines etc. Works with CEI to identify opportunities for external partnerships and contributes to the assessment of those partners for suitability aligned to specific assets. Contributes to the development of assigned assets in due diligence activities, out-licensing activities and identification of internal resources and teams to assist in associated activities with proposed external partners Will contribute to the continued mapping of process to maximize efficiencies and effectiveness Work with internal stakeholders and external partners to identify additional sources for pipeline enhancement and growth External Interactions and Partnerships Develop relationships with external Project Management networks (across industries) to identify best practices Utilizes advanced analytic tools to manage and monitor the progress of key metrics and KPIs. Shares best practices identified from external partners with Takeda Project Management network to develop Takeda’s internal PM capabilities. Develops the relationships within the defined external collaborations, setting and documenting clear expectations for how S&TS will work with its external partners Maintains database of key external resource pool (functional vendors and disease area experts). Monitors the contracting process to ensure rapid and agile engagement with external partners. Keeps abreast of operating models of other Pharma external networks / incubator models and evaluates opportunities for Takeda. Responsible for the maintenance of external facing media including but not limited to websites, microsites, portals etc. Portfolio and Program Management Responsible for reporting on budget of assigned assets to ensure that the consolidated, S&TS budget is accurate. Implements and ensures completion of S&TS specific inputs to the corporate portfolio process, by reporting regularly on those assigned assets to enable presentation of accurate information is available in a timely manner. Partners with Finance Lead to operationalize the portfolio process—providing group inputs in the TAU Finances and Portfolio processes. Manages individual program budgets for assigned programs within the portfolio Communication Prepare presentations for Senior Management and Executives (internal & external). Experience should include being primarily responsible for organizing and preparing focused messaging for presentations delivered to Executives, and being primarily responsible for ensuring Senior Management alignment in advance of Executive presentation. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 8-10 years related work experience B.S. degree in Scientific or related field is required. Advanced science degree desired Thorough knowledge of pharmaceutical industry and proven ability make things happen, deal with ambiguity and seek solutions. Understanding of business development activities as well as managing external interactions and supporting collaborations, Demonstrated strategic problem-solving ability including ability to challenge and work outside the status-quo. Demonstrated ability to clearly and concisely communicate with internal and external parties. Therapeutic area expertise is desirable. Highly effective written and verbal communication skills in order to manage, motivate and drive decisions within cross-cultural teams that are not co-located. Experience should include direct experience with leading teams that spanned geographies and functions/disciplines. Highly effective presentation skills in order create and deliver presentations with appropriate messaging and focused recommendations. Proven skills in negotiation, influencing without authority and working diplomatically through conflict. Proven people influencing skills. Sufficient knowledge of communication tools, including online meeting software and virtual meeting solutions like TelePresence, in order to select and operate the best tools that will facilitate communication across a cross-cultural team. Demonstrated technical knowledge in order to determine how project data can be organized meaningfully in order to facilitate Senior Management and Executive decision processes. Sufficient knowledge of all MS Office tools to be able to effectively capture and communicate project information. Detailed and in-depth knowledge of pharmaceutical industry with a focus on early drug development (i.e. Discovery, Regulatory, Early Clinical). Substantial experience (6-8 years) leading complex pharmaceutical project deliverables in a multi-disciplinary, global environment. PHYSICAL DEMANDS: May work at a computer for several hours at a time. TRAVEL REQUIREMENTS May travel domestically and internationally. Approximately 15% travel is required

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Associate Director, Medical Communications Lead

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OBJECTIVES: The Associate Director, Medical Communications Lead is a key member of the Global Medical Affairs (GMA) Oncology brand team for a hematology product that is marketed in the US by Takeda, and marketed ex-US by partner organizations. This individual will be responsible for driving an integrated Medical Communications brand strategy that is aligned with the overall brand strategy and medical strategy, and meets the needs of patients and health care providers (HCPs). To ensure the successful execution of the Medical Communications brand strategy, this role will partner with all Medical Communications Centers of Excellence (COEs), including publications, medical information, medical review, training, congresses, grants and sponsorships. The primary focus of the Associate Director, Medical Communications Lead is to provide support for the US Medical Affairs organization by creating and supporting Medical Communications activities (including, but not limited to, scientific platforms, advisory boards, and MSL resources), along with ensuring consistent use of brand‑specific scientific statements across the organization, and through different communication channels. The Associate Director, Medical Communications Lead will collaborate with other functions within GMA Oncology (eg, research and project management), as well as other departments within Takeda (commercial development, clinical development and preclinical/translational research) to ensure the Medical Communications strategy for the brand is aligned cross‑functionally. This individual will also be responsible for communicating the Takeda Medical Communications brand strategy with partner organizations ex-US, as well as supporting Medical Communications requests from partner organization, as appropriate (in-line with partnership agreements). In addition, the candidate in this position may support the Medical Communications needs and activities for pipeline products. ACCOUNTABILITIES: Support the brand Medical Director with planning the US medical strategy and tactical plans for the brand in collaboration with other GMA Oncology departments, commercial development, clinical development and preclinical/translational research. Drive an integrated Medical Communications brand strategy and tactical plan that is aligned with the overall brand strategy and medical strategy in partnership with the Medical Communications COEs. Chair Medical Communications team meetings for the brand to deliver consistent medical communications, to facilitate the development of the integrated Medical Communications brand strategy and tactical plan, and to track progress and successes. Deliver key Medical Communications activities including, but not limited to: Scientific platform: lead the development and continuous update of this foundational document including core scientific statements that inform all medical communications, and a scientific lexicon for consistency. Advisory boards and company-sponsored symposia: support development of materials and content, in collaboration with the brand Medical Director and vendors; ensure medical accuracy and appropriate review/approval. MSL field resources: support the development of resources to meet the needs of the US field team; ensure medical accuracy and appropriate review/approval. Lead cross-functional alignment and education to ensure appropriate incorporation of scientific platform evidence statements into all medical content and medical communications including, but not limited to, publications, company-sponsored symposia, medical information responses to unsolicited requests, slides decks, and field resources to support proactive and reactive scientific exchange. If required, support Medical Communications needs and activities for pipeline products in collaboration with the GMA Oncology pipeline team. Ensure the scientific integrity, quality and accuracy of all deliverables with a commitment to ethical practices in the preparation and dissemination of materials. Support the medical review of promotional and non-promotional materials for the brand and pipeline products, as appropriate. Critically evaluate the published medical and scientific literature related to Takeda oncology brands, pipeline products and relevant competitive products; maintain knowledge of product areas, current trends, and current literature. Manage funds and resources appropriately, including medical communications vendors. EDUCATION, EXPERIENCE AND SKILLS: Required: PharmD, PhD or MD degree. 4-5 years Medical Affairs experience or related industry experience. Excellent written and oral communication skills. Oncology experience strongly preferred. Preferred training/experience: Demonstrated results in one or more medical communications groups (eg, medical communications, publications, medical information, training). Understanding of pharmaceutical clinical development and product life-cycle management. Cross-functional team leadership experience within the Pharmaceutical or related industry. Competencies: Creativity and innovation: Proven ability to think outside the box and challenge status quo is mandatory. Strategic Approach: Ability to identify opportunities and anticipate changes in the business landscape through understanding and ongoing assessment of the environment. Engage Others: Ability to create a clear and unifying vision inspiring matrix teams to excel. Collaboration: Ability to cultivate a broad network of relationships throughout the organization. Lead Change: Facilitate adjustment to functional or cross-functional plans and priorities in response to changes in strategic direction. Drive for Results: Support the creation of functional strategies and goals that are closely aligned with company objectives, and develop metrics to track and assess performance. Pharmaceutical Industry Acumen: Strong understanding of the regulatory and compliance environment. LICENSES/CERTIFICATIONS: Maintain minimum standards of education/certification in individual professional discipline. TRAVEL REQUIREMENTS: Ability to drive to or fly to various meetings or client sites, including overnight trips. Requires approximately 20-30% travel

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Director, Forecasting and Optimization

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Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as Director, G2N Forecasting and Optimization in our Boston office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Director, G2N Forecasting and Optimization working on the Business Forecasting & Strategy team, you will be empowered and a typical day will include: Directs all aspects of planning and analysis for all contracted commercial and government contracts. This position is directly accountable for the detailed analysis and projections of over $2 billion in rebates and chargebacks which are incorporated directly into the US business unit P&L for Plan, MYC, LRF and LBE’s and are the basis for recording gross-to-net actuals. This position is also responsible for partnering with Managed Markets to perform a variety of financial/business analyses for all business segments to in an effort maximize US BU’s gross margin. The incumbent in this position is responsible for leading and communicating a variety of ad hoc analyses on issues not limited to contracting and pricing for senior/executive management. Directly responsible for leading the cross functional analysis of pricing and contracting strategy and understanding how that impacts financial results for both net sales and volume. ACCOUNTABILITIES: STRATEGIC FINANCIAL MODELING Develops pricing modeling strategy for Commercial Operations to support the analytical efforts to maximize profitability for the US business and utilize industry best practices. Lead product and market analysis to examine and improve profitability and market position for the US business. Research industry trends and utilize information on pharmaceutical industry, competitive information, market conditions, and other internal resources (Sales, Marketing, Finance,Forecasting) to positively impact contracting activities. Work with Sales, Managed Markets, Brand Heads and Commercial Finance to evaluate and recommend effective contract strategies, analysis, negotiation, and pricing tools and strategies for all US products, and future products. PLAN/MYC/LRF/LBE Direct strategy, and create procedures for the planning and analyses of rebates and Chargebacks (over $2 billion), market share, sales (over $3 billion), and profitability for all commercial and government contracts for Plan, MYC, LRF and LBE’s. Responsible for communicating net sales and volume impact of planning assumptions by channel. Collaborate with Managed Markets to create and communicate the pricing requirements for each business segment, develop the financial models, consolidate data to allow for multiple views of the information, and prepare presentations for Takeda review meetings.Work with Commercial Financial Planning to understand the financial impact of current gross-to-net reserves, pipeline stocking, existing and future contracting on Net Sales results. Collaborate with Brand Directors, Sales Force, and Commercial Financial Planning to develop assumptions, communicate issues to meet all deadlines and provide explanations and a wide-range of scenario analysis, variance analysis, sensitivity analysis, and other insightful ad-hoc analysis. Identify and address current and existing software application tools needed to ensure business functions are met and work with IT to improve system processes. Responsible for the organization and staffing of this area. Includes recruiting, selection, training, development, and performance management as well as the provision of all necessary equipment, supplies and services for maximizing operating effectiveness. EDUCATION, EXPERIENCE AND SKILLS: Required: ·Bachelor’s degree ·10 years of business experience ·5 years at management experience ·5 years of progressive experience in one or more of the following areas: Analytics, Marketing, Pricing, Contract Sales, or financial planning in the pharmaceutical or healthcare industry Desired: Master’s Degree in business administration or other related field is strongly preferred. Equivalent experience in pharmaceuticals or other related industry may be acceptable

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Associate Director, Clinical Translational Biomarkers, Cell Therapy

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Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Clinical Translational Biomarkers, Cell Therapy in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director working on the Cell Therapy Clinical Translational Biomarkers team, you will be empowered to provide strategic oversight of the Cell Therapy portfolio and recommend key selections and modifications to clinical trial design, and a typical day will include: POSITION OBJECTIVES: Takeda’ s Cell Therapy translational biomarker team is uniquely positioned to integrate cell product and clinical CART biomarkers to investigate correlatives associated with cell product efficacy and safety in oncology indications. This position’s primary role is to provide team leadership and scientific expertise in generating clinical and integrating cross-functional biomarker data from various line functions to investigate safety, efficacy and mechanisms of resistance and relapse in cell therapies. In this unique role you will be at the scientific forefront of cell therapies striving towards improving outcomes for patients with B cell malignancies and solid tumors. POSITION ACCOUNTABILITIES: Leads a team of 2-5 junior level Ph.D. scientists with translational expertise in immune-oncology and CART Prepares study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials. Investigates mode of action (MoA), critical quality attributes (CQA) and mechanisms of resistance and relapse in cell therapies through collaboration and integration of biomarker data from process development, manufacturing (CMC), product characterization, animal models, tumor microenvironment, clinical biomarkers, pharmacology, safety and efficacy. Provides strategic, technical and scientific leadership to cell therapy clinical project teams for integrated translational research strategy. Collaborates closely with other key line functions within the Oncology therapeutic area including discovery, DMPK and TREC Responsible for the development of project strategy and communicates complex data/decisions within department and cross functionally Presents study results at team or department meetings, to external partners or at conferences. Establishes project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders Commits resources to execute specific project tasks. Leads local and global initiatives or work streams Recognized as a subject matter expert in cell therapies or immuno-oncology EDUCATION, EXPERIENCE AND SKILLS: Education and Experience: Required: Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 15 years relevant industry experience Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 13 years relevant industry experience PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 10 years relevant industry experience Experience in multidisciplinary clinical projects and teams with ability to integrate cross-functional information Experience in CART, immunology, immune-oncology, vaccines or virology with strong understanding of solid tumor or B cell malignancies In-depth knowledge of various mechanisms of therapeutic response and resistance mechanisms utilizing in vitro, in vivo or ex vivo patient-derived models Understanding of current therapeutic and combination therapy landscape, including immune-checkpoint blockade, in cancer immunotherapy (IO) Understanding of various cell and gene therapies, gene editing technologies with previous experience in CAR T cells, large molecules, vaccines or viral vectors Experience with immune-phenotyping by FACS (flow cytometry), primary cell culture, immunofluorescence, ELISA, and PCR Understanding of cell product immunogenicity, potency and cellular immunology with analytical development experience Experience in clinical trials, balanced experimental design, data visualization and basic statistical analysis are desirable A track record of independent critical thinking and scientific achievement demonstrated by national presentations and publications Prior experience with translational aspects of IND, NDA or BLA desirable Knowledge and Skills: Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and, determine causes and possible solutions Teamwork Ability to work well on global cross-functional teams. Communication Skills -Able to expresses one’s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with senior management; technical writing skills to support authorship and approval of internal technical documents Organization – Exercises good time management and prioritization skills to balance multiple project and departmental objectives Technical - Subject matter expertise in a specific scientific area or areas. Demonstrated ability to successfully contribute across multiple scientific endeavors Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use Resource Management -Project management skills; ability to manage one’s time within individual, departmental, and corporate goals and timelines; management of internal external resources (vendors) External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Interacts with external vendors for projects Leadership Skills – Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives. TRAVEL REQUIREMENTS: May require approximately 10% travel.

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Director Digital Clinical Devices

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Job Description OBJECTIVES: Director has the responsibility of evaluating, qualifying and testing wearable device technologies in clinical trials to augment data collection. This role is essential to provide new data streams and contribute to deep patient phenotyping. ACCOUNTABILITIES: • Works with internal and external stakeholders to find optimal technological solutions and designs execution plans to address specific development program needs Directs all aspects of wearable device work including identification of appropriate technologies, external partners, designing strategy and execution and partnering with other functional lines to have the experiments executed Manages through change to adopt novel technological approaches and devices Develops and maintains a network of external partners to facilitate device implementation, data collection and analysis using wearable technologies in clinical trials Critically evaluates technologies, applications, identifies risks and develops mitigation plans for device deployment in clinical trials Responsible for development of data analysis plans, collaborates to get the data analysis completed and interprets the results Provides contributions to regulated documents including study protocols, informed consent forms and regulatory filings Works with external partners to monitor the external eco system for emerging technologies and novel data sources, critically evaluates novel technologies and provides recommendations for implementation Leads critical evaluation and prioritization of potential number partnerships and business opportunities Facilitates driving an internal process towards creating an optimal infrastructure to accommodate wearable data collection and analysis Partners with data management to establish data workflow process, appropriate internal infrastructure, assess applicability of data standards and facilitates data mapping to the databases Writes reports, initiates and reviews internal and external documentation. Presents at external and internal scientific forums. Builds and develops a high performing team. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: MS/PhD with Degree concentration in a quantitative, analytic, engineering or life science discipline required. 10 / years of industry experience in medical device development or management Relevant biotech, pharma or device industry experience is a must that includes device evaluation or drug development clinical trials Clinical science background with proven record of designing and executing clinical experiments is highly desirable Strong scientific and business acumen, strong analytical skills and ability to work independently Ability to develop and maintain strong internal and external partnerships, manage by influence to drive the process with the end result in mind Hands on experience with different types and formats of the data, working knowledge of data standards and regulatory requirements Familiarity with biomedical device regulation including the FDA 510K process Ability to adapt to quickly changing environment, multitask and prioritize multiple projects Practical knowledge of GxP regulations and legal requirements Ability to work collaboratively and influence others in a matrix setting Strong organizational and project management skills, attention to detail Excellent written and oral communication skills Ability to work in a global, multi-cultural environment

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Associate Director/Director, Project Management and Business Operations

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Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as Associate Director/Director, Project Management and Business Operations, CEI in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. The candidate provides project management, diligence, and leadership skills support to the Center for External Innovation (CEI) Business Development (BD) team in the successful identification, evaluation, and conclusion of transactions to meet Takeda’s strategic objectives. The CEI BD team is Therapeutic Area (TA) aligned across Oncology (ONC), Neuroscience (NS), Rare Disease (RD), and Gastrointestinal (GI) and responsible for all Research and Development stage Business Development activities. In this capacity, the Associate Director/Director of Project Management works closely with CEI-BD and with each Therapeutic Area Unit (TAU) and Drug Discovery Unit (DDU) to; (i) develop a partnering strategy that supports the TAU/DDU R&D strategies (ii) identify and triage opportunities consistent with the agreed strategy, (iii) lead cross-functional due diligence teams to efficiently assess opportunities of all types including acquisition, in-licensing, research collaborations and alliance opportunities across the R&D pipeline. This position is a critical role within this core team. The candidate also helps drive business and operational efficiency and effectiveness, creates and executes CEI’s external communication strategy; and develops, implements, and maintains CEI’s knowledge management systems. Summary of Responsibilities: Project Management Collaborate with the global CEI team as well as key stakeholders such as Legal, IP, Finance, and other members of the deal teams to develop and execute on the DDU’s and TAU’s external innovation strategies and plans. Depending on the specific role, lead BD diligence activities including triage of BD initiatives, formation of diligence teams, leading due diligence for specific opportunities under engagement, and reviewing the diligence output with stakeholders as appropriate Business Operations Develop and implement sustainable operating models, systems and processes to improve efficiency of CEI such as improving triage and due diligence processes, reduce cycle times for segments of the deal flow process, and solve organizational bottlenecks. External Outreach Collaborate with global CEI colleagues, as well as corporate communications, R&D communications, and external firms to develop communication strategies and corresponding marketing materials (print, online, social media, etc.) aimed at improving Takeda’s brand recognition and outside party perceptions of Takeda as a deal partner as well as for the effective communication of CEI’s mission to internal and external audiences. Plan for and manage externally-facing events e.g. networking events, BIO International, BIO Europe, and JP Morgan, and other conferences/events as relevant Knowledge Management Collaborate with global Takeda colleagues and external firms to assess user requirements and design technology solutions to address CEI’s needs such as contacts management and analytics, deal flow tracking and reporting and external innovation network analytics ACCOUNTABLITIES: Project Management Proactively drive project and resource priorities that align with the DDU and TAU external innovation business objectives. Assemble and manage cross-functional due diligence teams, define and track the progress of due diligence, outline key strategic objectives and operational plans for each transaction, ensure timelines are met for due diligence, ensure deal needs are defined and tracked (e.g. budgeting, financial evaluation, operational resources needed for post-deal management, etc.). Establish, communicate, and execute plans resulting in achievement of the external innovation project goals of each DDU and TAU. Partner with global CEI colleagues DDUs, and TAUs to develop and monitor project-specific timelines, identify ways to efficiently manage due diligence and other deal activities, make suggestions for improving the deal review and governance process. Communicate progress, lessons learned, and suggestions for improvement to CEI as well as to broader TAU/DDU community. Participate in the discussions with DDU, TAU, and Portfolio Management functions to set the external innovation strategy and plan DDUs and TAUs and prioritize external transactions. Business Operations Manage all aspects of DDU/TAU management update meetings including database updates, report generation, pre-read dissemination, and action plan follow-up. Improve triage process for potential deals to reduce resources spent evaluating off-strategy deals. Collaborate with CEI colleagues to redesign a fit-for-purpose due diligence process Revise and/or create new processes for due diligence to be used by CEI/BD Leads and PMs describing fit-for-purpose due diligence approach with key questions to be answered and roles/responsibilities for each stakeholder/key function by deal stage and type Create and implement streamlined due diligence reporting templates for each key due diligence team/stakeholder Measure CEI performance against metrics and report results to CEI senior management External Outreach Collaborate with global Takeda colleagues in CEI, GBD, Corporate Communications, and external firms to develop and successfully deliver effective communication materials for key meetings, conferences, and conventions. Plan for and manage externally-facing events conferences/events as relevant Knowledge Management Implement technology and process solutions to meet Takeda’s manage external innovation objectives (especially for the CEI and Research functions) in the areas of competitive intelligence, contact management, transaction management, and deal/opportunity evaluation and planning Develop processes and job aids for system users and foster wide adoption of the systems and process across CEI and Research. Develop and implement robust and user-friendly reporting capabilities of the Knowledge Management system. EDUCATION, EXPERIENCE AND SKILLS: Education Advanced degree in science or business-related field is required PMP certification is strongly desired MBA or equivalent is strongly desired Experience Thorough knowledge (minimum 10 years) of pharmaceutical industry and experience in Clinical Research, Regulatory, CMC, Marketing, or other drug development related function or related experience in strategic/management consulting to pharmaceutical industry. 6-8 years project management experience and/or proven leadership experience in managing a global, matrix team with or without direct reports. Significant relevant experience in global intercultural cooperation Proven leadership skills managing matrix teams, influencing outcomes and key project decisions, and strategic problem-solving ability Proven ability to communicate clearly and present key information objectively and collaborate effectively with management Demonstrated ability to clearly and concisely communicate/ prepare presentations for management Strong influencing skills Knowledge and Skills: Project leadership and management skills are essential Therapeutic area expertise is strongly desirable Ability to predict issues and solve problems by independent resolution Ability to articulate and establish processes that have impact cross-functionally, cross-divisionally, and cross-geographically Ability to drive decision-making within a cross-functional and cross-cultural global team structure Ability to work in a virtual setting/across time-zones, i.e., making effective use of communication tools (WebEx, TelePresence, telephone and video conferencing, etc.) Ability to inspire and motivate an interfacing and cross-geographical team Flexibility, tolerance, and diplomacy to best manage change and differing opinions Ability to work in a highly complex, multi-cultural, often stressful environment Highly effective communications skills – written and verbal Management of multiple tasks of varied complexity simultaneously Excellent organizational skills A solid business background as well as excellent commercial understanding are essential Effective negotiation and positive influencing abilities Proven ability to work effectively and diplomatically in conflict situations Highly effective presentation skills – create and deliver presentations with appropriate messaging and focused recommendations Microsoft Project Professional, SharePoint, Excel, PowerPoint & Word Fluency in English TRAVEL REQUIREMENTS: May travel to the US and Japan offices and other meeting locations internationally. Approximately 25% travel is required

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Medical Director/ Senior Medical Director, Translational Medicine – Neuroscience

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Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Medical Director/ Senior Medical Director, Translational Medicine – Neuroscience (NS) in our San Diego, CA office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. OBJECTIVES: To provide a key fulcrum of bidirectional Translational Research and Experimental Medicine (TREM), bridging the Neuroscience Drug Discovery Unit (DDU) and Therapeutic Area Unit (TAU) To facilitate a seamless transition of assets through the Takeda’s Neuroscience (Neurology / Psychiatry) R&D portfolio, through deep engagement in discovery and seamless transition between discovery/ preclinical into early clinical research To lead Translational Strategy Teams (TST) consisting of other Research and Clinical scientists to develop a Translational Research Plan (TRP), including design and oversight of preclinical and translational studies that will best inform clinical development To lead execution of the Translational Research Plan as part of the overall Asset Strategy in the Global Project Team To design and execute Experimental Medicine (“Phase 0”) clinical studies to establish human models that will accelerate quantitative, disciplined Go/NoGo decisions earlier in development To advise Global Project Teams and Clinical Subteams on execution of biomarker-driven Early Proof-of-Concept (EPOC) studies, based on the TRP and adoption of EM models To lead matrixed platform functions in development of biomarker platforms across modalities (Molecular, Imaging, and Neurocircuitry) that align with NS portfolio and specific project team needs This role embraces the principles of a translational/exploratory mindset, with a focus on deep scientific rigor and operational excellence ACCOUNTABILITIES: Acts as a key interface between the NS Drug Discovery Unit (DDU) scientists and Therapeutic Area Unit (TAU) clinicians to ensure portfolio prioritization and seamless transition of programs between research and clinical development Translational Medicine Lead (TML) on the Global Project Team (GPT), leading development and execution of the Translational Research Plan as part of the overall Asset Strategy Drive projects to rigorous assessments of therapeutic success or failure by testing clear scientific hypotheses as early, leanly, directly, and quickly as possible in the preclinical, translational, and experimental medicine stages of development Engages early (at Project Start and more intensively at lead optimization stages) with basic research colleagues to advise on translational strategies and inform portfolio prioritization Provides Translational Medicine expertise and recommendations to DDU on Go/No-Go decisions at candidate decision gates Leads the Translational Strategy Team (TST) bridging Research Project Teams to Global Project Teams (GPTs) to support molecular biomarker, imaging, neurocircuitry biomarker (electrophysiology / cognitive/behavioral / digital measures), and/or pharmacogenomic strategies and implementation Works closely with functional experts within Quantitative Translational Sciences (QTS) to ensure quality of the TRP and delivery of program-specific biomarkers and portfolio-relevant novel platforms Engages NS TAU clinicians, Regulatory, and Commercial leads during TRP creation to ensure Translational Medicine studies support decision-making for late phase development. Designs and implements clinical protocols for Experimental Medicine studies to test novel biomarkers and study designs in order to support earlier decision-making in development Contributes to authorship, review and approval of other key documents, including investigator brochures and INDs/CTAs as needed as well as co-authored publications in scientific journals Ensures agile, timely management of issues arising from ongoing studies, including serving as the study physician for adverse event reporting Works closely with Clinical Operations, Procurement, and Legal functions to support clinical study implementation of Experimental Medicine studies Provides Translational Medicine expertise for external opportunities, including participation in due diligence teams EDUCATION, BEHAVIORAL COMPETENCIES, AND KNOWLEDGE/SKILLS: Education, Experience MD, MD/PhD preferred Formal clinical training, including fellowship training with NS specialization, preferably Psychiatry Clinical development and/or translational/ experimental medicine expertise strongly preferred Clinical development experience should be in academia and/or industry, including early clinical trial design and implementation, documentation / filing Discovery/basic research experience is preferred Academic clinical experience is preferred Rigorous record of scientific publication is required Minimum 3-10 years biopharmaceutical/CRO health-related consulting company/academic industry early clinical development experience Distinctive ability to engage in discourse on innovative drug discovery from early preclinical through to late-stage development Behavioral Competencies Driving results is essential. Need to be able to motivate individuals in a cross-functional, matrixed organization and project team setting, to achieve and exceed goals by establishing accountabilities, clarifying performance expectations, agreeing to high standards and measures, monitoring and reviewing performance, and providing timely and relevant feedback. Demonstrated strategic thinker with an ability to create and drive a shared understanding of a long-term vision. Planning, priority-setting, and time management are essential. Accountability – takes responsibility for his or her own performance and accepts full ownership of issues, problems, and opportunities, regardless of the source. Comfort with ambiguity is required. Demonstrated creativity and innovation, including ability for divergent thinking and the propensity to question to traditional methods, processes, and products, as well as build on others ideas. Excellent communication, interpersonal sensitivity, and negotiating skills Team-work, partnership and collaboration skills Knowledge/Skills Neuroscience-related clinical expertise Basic and clinical science of neuroscience pathophysiology Translational medicine, including biomarkers Nonclinical and clinical drug discovery and development Regional/Global Regulatory requirements GCP/ICH EDUCATION, LICENSES, CERTIFICATIONS: Medical degree required MD-PhD preferred Board certification preferred TRAVEL REQUIREMENTS: Position based in San Diego, CA Ability to drive or fly to various meetings or client sites, including overnight and international travel Up to 20% travel time required

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Associate Director Immunology Cell Therapy

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Job Description More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, neuroscience and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth. Takeda Pharmaceuticals U.S.A., Inc. ranks among the top 15 pharmaceutical companies in the United States. Our larger U.S. offices are in Cambridge, MA, Deerfield, IL, and San Diego, CA. Research & Development employees in our Cambridge location focus on oncology, gastroenterology, immunomodulation, biologics, translational research, and external innovation. In March 2016, we opened our newest space at 300 Massachusetts Avenue, featuring 230,000 square feet of state-of-the-art office and lab space. While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director /Director of Immunology Cell Therapy in the GI Drug Discovery Unit in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director /Director of Immunology Cell Therapy working in the Gastroenterology Drug Discovery Unit team, you will be empowered to work cross-functionally with Takeda’s Cell Therapy Engine and Immunology team to contribute towards GI drug pipeline: POSITION OBJECTIVES: Takeda is making significant investments in cell therapies with the first approved and marketed cell therapy for fistulizing Crohn’s disease utilizing adipose mesenchymal stem cells-Alifosel. We have built an interdisciplinary cell therapy dedicated group as part of pharmaceutical sciences termed the Takeda Cell Therapy Engine as part of our commitment to this modality space. In addition, we have a multi-year joint collaboration termed T-CiRA (https://www.takeda.com/what-we-do/t-cira/) with a focus on iPSC based cell therapies. We are seeking a world class immunologist to help lead strategy and execution of programs focused on expanding immunologically based cellular therapies to treat disorders of the liver and gastrointestinal tract as part of the GI Drug Discovery Unit. He/she will collaborate with multiple stake holders within and outside of Takeda to identify novel immune based cellular therapies via internal research and external collaboration with biotech and academic partners for gastrointestinal diseases. The person will provide scientific project and strategic leadership for immunology based cell drug candidates through IND in collaboration with Translation Research and Early Target (TREC) discovery at Takeda. The GI Drug Discovery Unit has a growing interdisciplinary group of individuals focused on immune and non-immune cellular therapies along with gene therapy for gastrointestinal diseases such as inflammatory bowel disease, liver disease and enteric nervous system/neurodegenerative diseases. We are looking for a dynamic and driven individual join as an expert in immunology in the context of cell therapies. The AD/Director of Immunology will have wide visibility within the organization and among our academic and biotech partners. POSITION ACCOUNTABILITIES: Drives strategy in immunologically based cell therapies for GI diseases. Collaborates closely with GI Immunology in San Diego and our iPSC hub T-CiRA researchers at our Shonan - Japan as a scientific lead and/or advisor on immunological based cell therapy research programs. Functions as a scientific/ project lead for Takeda in our external biotech partnerships focused on immunologically based cell therapies for GI disorders such as inflammatory bowel disease. Acts as the scientific/ project lead for Takeda in our academic partnerships focused on immunologically based cell therapies for GI diseases Develop human first novel target ID approaches for our immunology programs using human data sets obtained via our human cell therapy programs. Establishes rapport & collaborates with scientific leaders, KOLs, academic partners, CROs and is seen as an international subject matter expert in Immunology research and therapeutics. Responsible for identifying partnerships with emerging biotech to establish partnerships to identify cell therapies and/or license innovative early development leads in collaboration with our business development colleagues. EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS: PhD or MD/PhD in immunology with a focus on mucosal biology of the GI tract. Expertise in cell therapies and/or iPSC technology is major plus but not necessary. 5-10 years of large pharma or biotech experience although a junior professor at a top tier academic institution with some industry experience (minimum of 2 years) would be considered. Postdoctoral work carried out in world-renowned Immunology lab Publication record in top scientific journals (International reputation) Track record of contributing to progression of immunology programs ranging from target discovery to clinical proof-of-concept in an industry setting Demonstrated creativity in scientific approaches and questions addressed Experience in managing teams in a matrix environment Experience in building and supporting partnerships with academic institutions and/or companies. TRAVEL REQUIREMENTS: The position is based in Cambridge, MA. Requires approximately 15-20% or more travel, including international travel

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