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Waltham

495 💼 Radius Health Jobs / Employment in Waltham, MA

Clinical Trial Manager - Waltham

newabout 5 hours ago
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Radius Health Radius Health is an equal opportunity employer.EEO/Disabled Individuals/Veterans.If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected] here to navigate to the “EEO is the Law” poster.Click here to navigate Radius Health’s Pay Transparency Policy.US-MA-Waltham Job ID 2019-1890 # of Openings 1 Category Clinical Ops - Dept Overview The Clinical Trial M

Senior Executive Administrative Assistant - Waltham

newabout 10 hours ago
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US-MA-Waltham Job ID 2019-1926 # of Openings 1 Category Executive Office Overview The Senior Executive Administrative Assistant will provide support to the CEO, acting with little supervision, anticipating needs while managing the daytoday workflow and prioritizing various projects, which includes scheduling, contact management, preparing materials for meetings, and participating in a wide range of special projects.The Senior Executive Administrative Assistant will perform, coordinate and overs

Director drug product technology

newabout 12 hours ago
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US-MA-Waltham | US-PA-WayneJob ID 2019-1912# of Openings 1Category Pharmaceutical Development/Operations

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Director of Project Management - Waltham

newabout 15 hours ago
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US-MA-Waltham Job ID 2019-1925 # of Openings 1 Category Clinical Ops - Dept Overview The Director of Project Management provides project leadership to cross-functional teams in the successful delivery of all phase drug development projects or sub projects within a major development program.These responsibilities include leadership of the team in predicting and planning solutions to achieve successful operational execution; driving the team to achieve clarity on issues and focus on effective con

Director, Clinical Operations - Waltham

newabout 15 hours ago
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Radius Health Radius Health is an equal opportunity employer.EEO/Disabled Individuals/Veterans.If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected] here to navigate to the “EEO is the Law” poster.Click here to navigate Radius Health’s Pay Transparency Policy.US-MA-Waltham Job ID 2018-1840 # of Openings 1 Category Clinical Dev - Dept Overview The Director, Clinic

Director, GCP Quality Assurance - Waltham

new1 day ago
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US-MA-Waltham Job ID 2019-1893 # of Openings 1 Category Quality - Dept Overview The Director GCP, Quality Assurance, will have the responsibility to serve as a subject matter expert to ensure that all quality and regulatory compliance related to GCPs, pharmacovigilance, and other related activities performed by Medical/Clinical Departments.The incumbent will provide support and promote collaboration to ensure all systems, processes and their outcomes are compliant with GCP guidelines, and appli

Head of Pharmaceutical Science/Development

new1 day ago
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Head of Pharmaceutical Science/Development Head of Pharmaceutical Science/Development Job Locations US-PA-Wayne | US-MA-Waltham Posted Date 4 weeks ago(2/25/2019 8:35 PM) Job ID 2019-1913 of Openings 1 Category Pharmaceutical Sci - Dept Overview Radius Health is searching for a Head of Pharmaceutical Science/Development, Tech Ops. with sound technical and leadership capabilities to develop our promising pipeline and support our commercial products. Reporting to the Senior VP of Technical Operation and a member of the Technical Operations Leadership Team, this role is accountable for leading and developing a high performa

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Senior Director, Biostatistics

new1 day ago
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Senior Director, Biostatistics Senior Director, Biostatistics Job Locations US-MA-Waltham Posted Date 1 month ago(2/21/2019 5:27 PM) Job ID 2019-1908 of Openings 1 Category Biometrics - Dept Overview The Senior Director Biostatistics oversee all the biostatistics, data management and programming tasks for Radius studies (nonclinical, CMC, clinical, safety, epidemiological or cross-sectional). The role will manage and lead the team to ensure appropriate statistical approaches for the design and analysis of clinical and nonclinical studies are employed and ensure the proper interpretation and presentation of results.

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Senior Executive Administrative Assistant

new2 days ago
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US-MA-Waltham Job ID 2019-1926 of Openings 1 Category Executive Office Overview The Senior Executive Administrative Assistant will provide support to the CEO, acting with little supervision, anticipating needs while managing the daytoday workflow and prioritizing various projects, which includes scheduling, contact management, preparing materials for meetings, and participating in a wide range of special projects. The Senior Executive Administrative Assistant will perform, coordinate and oversee administrative duties while providing an extensive level of support and handling details that are highly confidential and critical in nature. This position requires thorough knowledge of company operations, policies and procedures. Responsibilities Directly supports CEO in terms of calendar, travel, expenses, coordinating day-to-day and long-term management of Board of Directors meetings, projects and priorities in a timely, detailed and organized manner. Preparing /updating presentation materials as requested for meetings on Microsoft Office including but not limited to PowerPoint, Word documents, and Excel worksheets. Makes high-level contacts of a sensitive nature inside and outside the company. Handles details of a highly confidential and critical nature. Maintains phone contacts and calendars, schedules and coordinates internal and external meetings as needed. Draft and edit correspondence, articles, reports and presentations; transcribe meeting notes Handle phone, email and postal mail inquiries and respond appropriately for CEO Coordinate and manage special projects, including working collaboratively with various departments to assure projects meet deadlines Collects and prepares information for use in discussions/meetings of executive staff and outside individuals. Identifying administrative needs for the organization and initiating projects to support those needs. Provides back-up support and general assistance for other office Administrative Assistants as needed. Qualifications Bachelor's degree or equivalent and 7-10 years of directly related experience required. Previous experience supporting CEO is required. Proficient in Microsoft Outlook, Word, Excel and PowerPoint. Pharmaceutical Industry experience highly preferred. Well organized individual able to coordinate meetings for CEO and be able prioritize in a fast-paced operating environment. An excellent communicator skilled in both writing and PowerPoint. Demonstrated ability to manage an external facing role with diplomacy and grace dealing with Senior Leaders in the finance and biotechnology industries as well as individuals at nonprofit or governmental organizations. Experience in a global environment with awareness of cultural differences in business practices in major countries. Ability to maintain confidentiality of highly sensitive information, interactions, and situations. Strong typing, editing, proofreading, grammar, and scheduling skills. Excellent organizational, verbal, written communication skills as well as strong interpersonal skills required. Ability to work with minimal supervision and apply good judgment. Occasional (often local) travel is required - approximately 10-15%. PM18 PI108638594

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Director, Drug Product Technology

new2 days ago
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US-MA-Waltham | US-PA-Wayne Job ID 2019-1912 of Openings 1 Category Pharmaceutical Development/Operations Overview Radius Health is searching for a Director, Drug Product Development, Tech Ops. with sound technical and leadership capabilities to develop our promising pipeline and support our commercial products. Reporting to the Head of Pharmaceutical Sciences, the Director of Drug Product Development is accountable for the formulation and process development, scale-up and production of dosage forms for clinical trials and commercial drug products including drug product-device combinations. The individual we are seeking will have a well-established track record of successfully developing drug product formulations and processes through concept to commercialization across multiple modalities. In addition, the successful candidate will have demonstrated capabilities in working cross-functionally with internal stake holders and effectively managing development activities at external vendors. The position holder needs to have a broad range of knowledge across the various functional areas in pharmaceutical development, understand manufacturing technologies, people and organizational structures. The role enables high performing internal and external development teams to successfully develop, commercialize, and file products. In addition, this role will oversee the development of peptides, small molecules, injectables, solid dosage form, and transdermal devices with associated analytical methods. Responsibilities Key responsibilities include leading the development, scale-up, validation and registration of drug products and drug-device combination within the Radius portfolio, managing drug product development activities at external vendors in accordance with applicable regulatory and quality requirements and working closely with internal project teams to ensure drug product development activities and timelines are aligned with project and corporate goals. Ensures appropriate technical, scale-up, validation and production strategies/timelines are in place for drug product and drug-device combinations to meet the programs clinical supply and registration needs in accordance with corporate goals Manages drug product development activities at external vendors including providing input into the design of experiments, managing timelines, reviewing technical and batch manufacturing documentation and ensuring that Radius's business needs are met by the vendor Implement Quality by Design (QbD) principles in drug product development programs including technical risk assessments, identification of critical quality attributes and process parameters, and manufacturing control strategies Prepare pharmaceutical development reports and other technical documentation required for regulatory submissions, including authoring, review and approval of requisite sections of the IND, CTA, IMPD, NDA, MAA or other filings Work collaboratively within Technical Operations and across internal stakeholder functions such as Project Management, Clinical and Regulatory to meet program goals, including representation on CMC development teams and corporate product development teams where required. Work closely with Analytical Development to ensure that appropriate methods are in-place for the characterization and release of drug products, and supply chain to ensure that drug product is available for clinical and commercial use in accordance with project timelines Provide input into the preparation, maintenance and tracking of budgets and timelines associated with drug product development activities Ensure that all work is conducted in accordance with applicable Radius policies and procedures, CGMP and regulatory standards and guidelines. Participate in evaluating licensing and due diligence opportunities. Lead and participate in strategic initiatives for improving functional process within Technical Operations Maintain an understanding of current laws & regulations applicable to the pharmaceutical/biotechnology industry Qualifications PhD. in Pharmaceutical Sciences or related discipline with at least 10 years of relevant experience in pharmaceutical development and validation Experience in successfully leading drug product development and manufacturing activities at external vendors Experience in combination products or devices is a plus Knowledge and experience of applying QbD principles to the design and manufacture of drug product formulations and processes Strong project management skills and the ability to prioritize and align drug product development activities with broader project goals Flexible, adaptable and collaborative style with a willingness to take on new challenges and positively respond to changes Knowledge of current regulatory guidance's and experience in managing IND and NDA filings Excellent interpersonal, technical writing, and oral communication skills. PM18 PI108356516

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Senior Director, Biostatistics

new2 days ago
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US-MA-Waltham Job ID 2019-1908 of Openings 1 Category Biometrics - Dept Overview The Senior Director Biostatistics oversee all the biostatistics, data management and programming tasks for Radius studies (nonclinical, CMC, clinical, safety, epidemiological or cross-sectional). The role will manage and lead the team to ensure appropriate statistical approaches for the design and analysis of clinical and nonclinical studies are employed and ensure the proper interpretation and presentation of results. Responsibilities Oversees and develops the Biometrics team; supervises hiring of team members and conduct development. Oversees input on design of study, reviews protocols, and database requirements. Provides strategic and critical thinking to support decisions and drive direction of development strategy through collaboration with various business functions Conceives and writes SAPs & statistical methods sections for clinical trial and research protocols. Performs sample size calculations in conjunction with clinical staff to determine adequate number of research subjects for valid interpretation of results. Oversees statistical analysis for all ongoing studies and decided final interpretation in conjunction with other senior researchers and management. Plans data subsets to be analyzed. Creation and modification of statistical programs to analyze, review or summarize data. Conducts statistical analysis and interprets results. Prepares statistical reports, tabulations, and graphs for presentation at meetings or conferences, and for publication in technical journals. Develops proper statistical methods and formulas for complex study designs. Oversees statistical programming and database management personnel involved in clinical data processing, including case report form design, data tracking, data entry codes and document processing. Organizes the distribution of tasks and resources in the Biometrics group to maximize quality and to accelerate output by outsourcing non-strategic initiatives. Selects in collaboration with Clinical Development, Clinical Operations, QA and Medical Affairs, the CRO(s) that would be contracted and fulfill the corporate requirements. Sets up and maintains a preferential relationship with the CRO(s) to ensure success in the deliverables both in time and quality. Contributes to the discussion and drafting of Program documents e.g. CDP, SIP (Stats Integration Plans) and the integration of results from entire programs (ISE, ISS, ISI) Participates in the due diligence of potential new acquisitions to assess the bio statistical strength of their data. Oversees the Data Management Plan for programs and studies. Estimates statistical and programming time requirements for team timelines. Ensures necessary SOPs are developed or updated to support the quality and timeliness of team deliverables. Validates standard programs and macros written by other programmers. Guides the drafting and review of the study level documents e.g. SAP, TLF templates. Remains current about new developments in Statistics and Data Management and sharing these with R&D groups and teams. Qualifications PhD or equivalent in Statistics, Biostatistics or related discipline required. 10 years of experience in the biotech/pharmaceutical industry. Oncology experience highly preferred 3 years of SAS programming experience. 10 years of leadership experience of a bio statistical department. Deep understanding of drug development and biopharmaceutical industry Strategic and critical thinking to support leadership decisions and drive direction of development strategy Strong leadership and management skills, and ability to effectively lead and collaborate with various business functions High attention to detail including proven ability to manage multiple, competing priorities Specialized knowledge and licenses: Strong SAS skills in SAS BASE, SAS MACRO, SAS STAT languages. Critically review protocol and statistical analysis plan for statistical/programming needs. Knowledge of CDISC data standards. Program analyses of data from SAS datasets. Program outputs e.g. tables, graphs and listings. Strong knowledge and solid understanding of clinical trials. Strong programming, analytical, verbal, written communication. Ability to manage vendors regarding timelines and deliverables. Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PM18 PI108356520

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Director, GCP Quality Assurance

new2 days ago
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US-MA-Waltham Job ID 2019-1893 of Openings 1 Category Quality - Dept Overview The Director GCP, Quality Assurance, will have the responsibility to serve as a subject matter expert to ensure that all quality and regulatory compliance related to GCPs, pharmacovigilance, and other related activities performed by Medical/Clinical Departments. The incumbent will provide support and promote collaboration to ensure all systems, processes and their outcomes are compliant with GCP guidelines, and applicable international and national standards, regulations and guidelines. Act as a Radius representative during regulatory agency inspections and vendor audits. Responsibilities Assists in the implementation of GXP compliant procedures and operations to ensure a robust quality management system for both the conduct of clinical studies as well as prepare the company to successfully commercialize pharmaceutical products Proactively provides GCP QA support to Clinical Operations based on analysis and interpretation of updates to GCP regulations to assure best Clinical/QA practices Assists with the organization, preparation, coordination, and documentation of regulatory inspections Schedules and conducts Good Clinical Practice (GCP) Audits of systems and processes related to clinical operations, pharmacovigilance and clinical drug development. Provides GCP compliance oversight of internal systems and processes as well as those of CROs, Vendors, and Clinical Investigator Sites. Reviews and provides input to clinical documentation (protocols, study reports, IB) Develops and measures quality metrics to drive consistent quality standards throughout the organization. Qualifications Bachelor's degree is required with 7-10 years' experience and 5 plus years' experience in Quality Systems related to GCP. Demonstrate ability to effectively communicate and influence the outcomes of the decision making process Analytically strong with practical knowledge of how to identify key performance metrics for quality indicators to set targets for maintaining a state of control while identifying areas for improvement. Extensive experience auditing clinical CRO's, clinical sites and investigator sites. PM18 PI108356522

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Clinical Trial Manager

new2 days ago
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Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HRconnectradiuspharm.com. Click here to navigate to the “EEO is the Law” poster. Click here to navigate Radius Health’s Pay Transparency Policy. US-MA-Waltham Job ID 2019-1890 of Openings 1 Category Clinical Ops - Dept Overview The Clinical Trial Manager manages and oversees clinical operation activities across a single clinical program or group of related studies, and ensures all assigned operational trial deliverables are met according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines. Responsibilities Contributes to Global clinical / regulatory submissions (FDA, EMA, Canadian and other countries), by helping out with in house and site inspection readiness planning/training, Manages clinical study/studies according to global regulatory requirements. Leads cross functional study execution team to ensure goals and timelines are met. Manages and oversees CRO/Vendors to ensure compliance with processes and regulatory guidelines. Manages MS Project timeline. Supports the tracking of trial budget(s) working closely with the appropriate partners. Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems. Anticipates potential study issues and prepare contingency plans with minimal oversight. Facilitates Clinical Agreements through Clinical and Legal Review. Reviews all study documents for accuracy and quality content. Drafts sample preparation instructions in accordance to Radius standard operating procedures (SOPs) and good clinical practice guidelines (GCPs). Performs onsite co-monitoring, training, or motivational site visits, as needed. Drives traceability procedures for investigational products and coordinates clinical supply planning with cross functional team members. Develops study specific documents such as pharmacy and operational manuals. Reviews and approves, as needed, study documents such as monitoring reports, essential regulatory packages, ICFs, etc. Trains CRO team members and site staff, as needed. Responsible for day-to-day management of vendors working on assigned study, including setting expectations, training, managing timelines and deliverables, and issue management. Provides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report. Some travel will be required (10-20% depending on project needs). Qualifications BA/BS in a scientific field (preferred) of study with 5 years of relevant experience working in Clinical Operations in the Pharmaceutical/ biotech industry and/or a CRO. CRA experience preferred. Experience with trial master file organization, regulatory documents, inspection preparation/readiness (site and Sponsor) and all aspects of trial and vendor management. Strong verbal and written communication skills. Ability to deal with competing priorities, detail oriented and creative problem solving ability is essential. Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required; basic statistical knowledge a plus. Ability to work independently and also in a collaborative team environment. Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook; Electronic Data Capture Systems). PI108356524

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Head of Clinical Operations

new2 days ago
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Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HRconnectradiuspharm.com. Click here to navigate to the “EEO is the Law” poster. Click here to navigate Radius Health’s Pay Transparency Policy. US-MA-Waltham Job ID 2018-1848 of Openings 1 Category Clinical Ops - Dept Overview The Sr. Director, Clinical Operations is responsible for leading and driving clinical trial operations for Radius' current and future programs. This role will oversee the Radius Clinical Operations team to ensure all assigned operational trial deliverables across programs are completed according to timelines budget, operational procedures, quality standards, SOPs and business guidelines. This individual will need expertise in successful planning, implementation, and delivery of clinical operations strategy, plans and study execution. The Sr. Director, Clinical Operations will also be responsible for managing and supporting vendor/CRO relationships and activities including negotiations and performance evaluations. This individual will be a member of the R&D leadership team and will be a significant contributor to the overall R&D strategy at Radius. Responsibilities Provide functional leadership for clinical operations, including hiring, training, staff assignments, coaching, mentoring and performance management in a matrix environment Set department goals and objectives which align with broader company goals Provide strategic and tactical input into integrated clinical development strategy and timelines Develop clinical operations strategy including risk management and contingency planning Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials Guide the clinical operations execution activities of all clinical trials Establish and maintain strategic partnership with Radius CROs and clinical vendors to include vendor governance and identification and resolution of performance issues Ensure all clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs]) Maintain procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systems Contribute to global regulatory submissions (FDA, EMA, Health Canada and other governing regulatory bodies) Oversee the clinical operations aspects of cross functional work processes involving medical writing, legal, finance, quality assurance, pharmacovigilance, biometrics, program management, regulatory, pharmaceutical sciences, IT, medical affairs, translational science and clinical science Drive the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes Foster a highly collaborative culture and serve as a leadership role model within the company and with external stakeholders Qualifications 12 years of clinical operations experience in a pharmaceutical, biotech and/or contract research organization (CRO) setting; including management of a CRO 8 years supervisory experience, 5 years direct project/trial management experience and 4 years in leadership role Requires a BS in the health or life sciences or equivalent Osteoporosis or oncology experience is preferred Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Strong leadership, collaborative and interpersonal skills Proven ability to build strong relationships with CROs/vendors Excellent computer skills (Microsoft Office Suite, Project, Visio, Electronic Data Capture and Trial Master File Systems) Global Clinical Trial Experience and the ability to support more than one clinical trial is preferred Experience working independently and in a team environment, being flexible and adapting in a changing environment Ability to travel up to 30% Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PI108356533

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Senior Medical Director, Pharmacovigilance

new2 days ago
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US-MA-Waltham Job ID 2018-1854 of Openings 1 Category Pharmacovigilance - Dept Overview Senior Medical Director, Pharmacovigilance will drive and oversee the company's pharmacovigilance processes. The Senior Medical Director will participate in oversight of all post-marketing and clinical safety and pharmacovigilance activities. Will ensure timely, consistent, and accurate safety reporting in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs), and standard operating procedures (SOPs). Responsibilities Oversee investigational and post-marketing regulatory reporting and pharmacovigilance activities for assigned products. Medically review individual case safety reports from all sources for assigned products. Oversee, prepare, and review Periodic/Annual Reports (FDA) and Periodic Safety Update Reports and other Benefit/Risk Update Reports (FDA and Global Regulatory Authorities). Drive, prepare, and review responses to ad hoc regulatory queries, and signaling topic reports. Develop and maintain state-of-the-art pharmacovigilance processes and procedures. Oversee pharmacovigilance activities as a member of drug development project teams; lead Safety Review Teams. Drive safety-related labeling activities for assigned products. Participate in the management of PV vendor for safety database and case processing Support MAA submission when needed Qualifications MD Degree required; Postgraduate training in a clinical discipline subspecialty preferred. Hands-on clinical practice experience is desirable A minimum of 7-10 years of Pharmaceutical Industry experience within the Drug Safety Department required. Global drug safety experience required. Strong knowledge of Periodic Safety Update Report (PSUR) and the ability to interface with international partners is required. A working knowledge of ICH guidelines and global regulations and must be experienced in safety reviews of IBs, protocols, final clinical study reports, and summaries of safety is required. Experience using a large-scale electronic data storage and retrieval system, required. Ability to read, analyze and interpret scientific and technical journals. Post-marketing and investigational event and aggregate assessment/review/ documentation skills; must have experience is writing/oversight of Annual Reports, PSURs, Type II Variations Working knowledge of MedDRA coding and case series retrieval strategies. Ability to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation. Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products. Ability to work with international collaboration partners and CRO's Must have very strong English language writing skills and mature verbal communication and presentation skills. PM18 PI108356530

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Director, Clinical Operations

new2 days ago
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Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HRconnectradiuspharm.com. Click here to navigate to the “EEO is the Law” poster. Click here to navigate Radius Health’s Pay Transparency Policy. US-MA-Waltham Job ID 2018-1840 of Openings 1 Category Clinical Dev - Dept Overview The Director, Clinical Operations will provide oversee the execution of clinical trials within the development programs. The incumbent will serve as the governance contact for the CRO and clinical vendors, will ensure that all assigned operational trial deliverables are met according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines. Responsibilities Provides strategic input to the clinical development plan Develops the operational plans for trials within the assigned development program(s) Oversees trial execution team to ensure delivery of clinical trial within budget and agreed upon timelines Identifies and/or anticipates operational risks and mitigation plans across trials within the development program and escalates issues to senior management as necessary Manages the quality of work performed by direct reports (i.e. AD, CTM, CRA, and CTC) through regular review and evaluation of work product. Acting as a coach and mentor. Serves as the relationship manager for CRO/Vendors and is a member of the joint oversight committee Reviews CRO/Vendor agreements and negotiates the performance metrics to be outlined within the agreements Contributes to Global clinical / regulatory submissions May perform periodic visits to sites and/or vendors to assess progress and compliance Presents status reports of operational execution activities to senior management Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial Qualifications 12 years of clinical operations experience in a pharmaceutical, biotech and/or contract research organization (CRO) setting; including management of a CRO. 7 years supervisory experience, 5 years direct project/trial management experience and 2 years in leadership role Strong collaborator with excellent communication skills; "Can do" attitude. Requires a BS in the health or life sciences or equivalent. Oncology experience is highly preferred. Experience with trial master file organization, regulatory documents, inspection preparation/readiness (site and Sponsor) required. Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required; basic statistical knowledge preferred. Excellent computer skills (Microsoft Office Suite, Project, Outlook; Electronic Data Capture and Trial Master File Systems). Global Clinical Trial Experience and the ability to support more than one clinical trial is required. Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PI108356535

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Director of Project Management

new3 days ago
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US-MA-Waltham Job ID 2019-1925 of Openings 1 Category Clinical Ops - Dept Overview The Director of Project Management provides project leadership to cross-functional teams in the successful delivery of all phase drug development projects or sub projects within a major development program. These responsibilities include leadership of the team in predicting and planning solutions to achieve successful operational execution; driving the team to achieve clarity on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making on projects. This position will have a high level of interaction with Senior Management to ensure that the scientific strategy is clearly integrated into operational plans. Responsibilities Leads the planning efforts for assigned development programs in defining and implementation of the Transdermal Project Team strategy and operational plans. Manages the operational plan and formulates the project scope, project plan, critical paths and risk-mitigation strategies with the Transdermal Project Team and the Senior Management team. Identifies and drives project and resource priorities that align with the business objectives that identify ways to accelerate the project execution where possible while maintaining high quality standards. Develops strong logistical skills to manage activities across functions and regions. Manages the identification and escalation of potential issues/risks or obstacles and achieves resolution or plans contingencies and follow issues through to resolution ensuring that all issues arrive at a singular conclusion or recommendation. Establishes, communicates and executes plans that drive toward goal achievement. Generates collaboration, cooperation and communication across functions teams to achieve stated goals. Responsible for setting and managing expectations, highlighting and resolving issues, ensuring regular communications and managing internal and external activities. Facilitates the system to track and monitor program objectives/goals. The scope of responsibilities extends from early clinical development through commercialization and post-marketing commitments. Qualifications Requires a Master's degree and a minimum of 5-7 years' experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environment. PhD, MD or PharmD a plus. Extensive drug development experience with biologics in Phase 1-IV and Commercialization is preferred. Proven leadership experience in managing a global, cross-functional team with demonstrated skills in strategic planning, risk mitigation, and operation problem solving. Solid working knowledge of functional IND, BLA and NDA components/requirements required. Ideal candidate has worked on a program(s) that lead to successful regulatory approval (i.e., NDA, BLA, MAA, or SNDA). Experience in osteoporosis or transdermal drug delivery technologies preferred but not required Excellent verbal, written, and organizational communication skills. Proficient in Microsoft Office including Word, Excel, PowerPoint, Microsoft Project and Outlook Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PM18 PI108618442

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Senior Systematic Reviewer (Research Associate III) Meta Research ( Waltham MA or London UK)

new3 days ago
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Senior Systematic Reviewer (Research Associate III) - Meta Research ( Waltham MA or London UK)**We are looking to fill this role in our Waltham , MA or

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Class A CDL Drivers: Be Your Own Boss with Lease Purchasing! ( Waltham , MA )

new4 days ago
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…EVERY NIGHT! BECOMING YOUR OWN BOSS HAS NEVER BEEN EASIER. The RoadOne Lease Purchase Program puts CDL Class A Truck Drivers behind the wheel of your very own driving

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Senior Systematic Reviewer (Research Associate III) Meta Research ( Waltham MA or London UK)

new4 days ago
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Senior Systematic Reviewer (Research Associate III) - Meta Research ( Waltham MA or London UK)* * We are looking to fill this role in our Waltham , MA or

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Waltham RN/LPN

new4 days ago
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…RNs and LPNs! For patient opportunities North and West of Boston, MA including: Amesbury, Waltham , Concord, Cambridge, Lexington, Newton, Billerica, Burlington,

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Head of Clinical Operations

4 days ago
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Head of Clinical Operations Head of Clinical Operations Job Locations US-MA-Waltham Posted Date 2 months ago(1/30/2019 3:23 PM) Job ID 2018-1848 of Openings 1 Category Clinical Ops - Dept Overview The Sr. Director, Clinical Operations is responsible for leading and driving clinical trial operations for Radius’ current and future programs. This role will oversee the Radius Clinical Operations team to ensure all assigned operational trial deliverables across programs are completed according to timelines budget, operational procedures, quality standards, SOPs and business guidelines. This individual will need expertise in s

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Senior Executive Administrative Assistant

5 days ago
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US-MA-Waltham Job ID 2019-1926 # of Openings 1 Category Executive Office Overview The Senior Executive Administrative Assistant will provide support to the CEO, acting with little supervision ...

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Experienced CDL-A Truck Drivers ( Waltham , MA )

6 days ago
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…CALL NOW TO SPEAK WITH A RECRUITER: (866) - EXCELLENT BENEFITS: Medical /Dental/Vision/Prescription Drug plans 401k Paid Vacation High Tech Equipment Paid Weekly

jobs byJuju.com

Director of Project Management

6 days ago
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US-MA-Waltham Job ID 2019-1925 # of Openings 1 Category Clinical Ops - Dept Overview The Director of Project Management provides project leadership to cross-functional teams in the successful ...

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Senior Global Recruiter Human Resources ( Waltham , MA or Bethesda, MD)

13 days ago
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Senior Global Recruiter - Human Resources ( Waltham , MA or Bethesda, MD)Position Overview:Reporting to the Executive Director of Global Recruitment, serves as a

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Senior Global Recruiter Human Resources ( Waltham , MA or Bethesda, MD) - Evidera

13 days ago
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Senior Global Recruiter - Human Resources ( Waltham , MA or Bethesda, MD) Position Overview: Reporting to the Executive Director of Global Recruitment, serves as a

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Senior Director, Biostatistics

about 1 month ago
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US-MA-Waltham Job ID 2019-1908 # of Openings 1 Category Biometrics - Dept Overview The Senior Director Biostatistics oversee all the biostatistics, data management and programming tasks for Radius ...

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Clinical Trial Manager

2 months ago
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Click here to navigate Radius Health's Pay Transparency Policy. US-MA-Waltham Job ID 2019-1890 # of Openings 1 Category Clinical Ops - Dept Overview The Clinical Trial Manager manages and oversees ...

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Director, Drug Product Technology

3 months ago
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US-MA-Waltham | US-PA-Wayne Job ID 2019-1912 # of Openings 1 Category Pharmaceutical Development/Operations Overview Radius Health is searching for a Director, Drug Product Development, Tech Ops ...

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Head of Clinical Operations

5 months ago
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Click here to navigate Radius Health's Pay Transparency Policy. US-MA-Waltham Job ID 2018-1848 # of Openings 1 Category Clinical Ops - Dept Overview The Sr. Director, Clinical Operations is ...

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Director, Clinical Operations

6 months ago
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Click here to navigate Radius Health's Pay Transparency Policy. US-MA-Waltham Job ID 2018-1840 # of Openings 1 Category Clinical Dev - Dept Overview The Director, Clinical Operations will provide ...

jobs byZipRecruiter

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