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276 💼 Bristol Myers Squibb Company Science Jobs / Employment

Associate Director, International Regulatory Strategy Lead

new3 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Description: Scope : Products (DP5 to DP8 and beyond, including initial submissions, major variations) - BMS Footprint except US, EU, Japan, China, Canada, Switzerland Advise and support Local GRS for assessing regulatory landscape and regulations to optimize our regulatory strategies and submission plans within and across a therapeutic area (TA) product portfolio Provide actionable Regulatory Input into Development Strategy to enable timely commercial desirable registrations across the region. Advise global team on specific local requirements or gaps in clinical program to support local submission and collaborate to develop mitigation plans (e.g. bridging/sub-population requirements) Champion for countries to obtain needed global and regional resources (e.g., to participate in global trials, to prepare bridging reports, to respond to HA queries rapidly) Strategize with GRT Lead and other core GRT members on the regulatory strategy for NCEs and major variations (e.g. line extensions, new indications, label enhancements) and to foster one regulatory voice Interface between Global and Local, the ISLs lead International Regulatory Teams engage the local GRS regulatory teams, communicate Project specific information (follow-up, update) to local teams, ensure alignment between registration/submission requirements and development plans, translate global regulatory expectations into local plans and lead the execution of these plans, digest and communicate Global Regulatory plans, including HA engagement plans to countries, digest and communicate results for key clinical trials, obtain aligned regulatory position,Represent and deliver the Global TA position, track the execution of the global submission plan. ISLs Co lead with GRTLs the development and execution of the Global Regulatory Engagement Plan Transversal activities : Represent GRS international on R&D (FDT/EDT/LCM/MLT/IDT) teams on an ad hoc basis to communicate and advocate regional regulatory strategies and plans when agenda is relevant to the international markets Primary interface, ISLs collaborate and partner with other International counterparts (Commercial, Medical, Access, HEOR, supply chain, TO) to obtain alignment with the regulatory strategies and submission plans (as applicable) International support for alliances ISLs participate in external partnership negotiations, execution and and implementations, when applicable, to ensure advanced awareness of regulatory risks and seamless integration Represent GRS and/or GRS International on specific non-product related projects when ISL role input is required or when an opportunity arises Qaulifications: Regulatory Experience in Local, Regional or Global group (Country Head, GRM, EUL, USL, country regulatory manager, etc.) or R&D experience in drug development (GDO, RCO, etc.) Experience in Oncology Therapeutic area is preferred Experience with understanding and advising regulatory strategies in coordination with clinical plans and marketing objectives. Ability to represent GRS functions on project team. Experience with understanding multiple local country environments and regulations Ability to translate local regulatory requirement in global action plan Experience with communicating regulatory strategy, issues, and risks in written and verbal format to multiple BMS stakeholders (Commercial, Medical, Market access ) Experience coordinating communications within teams and across functions. Experience applying project management techniques within teams. Experience in effectively managing meetings and driving plans while functioning remotely. Key requirements: Demonstrated ability to break down complex, scientific content into logical components. Demonstrated ability to facilitate issue resolution. Demonstrated ability to organize / prioritize tasks. Understanding of tactical role of GRS in the drug development process. Understanding of general global regulatory requirements for drugs in development. Understanding of PD&C process and specific GRS responsibilities / deliverables at PD&C Decision Points for International

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Associate Protocol Manager

new3 days ago
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About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are a passionate industry leading organization committed to making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents, ideas, and integrity to collaborate and swiftly deliver operational excellence and high-quality data. We are driven to make a difference, from cutting edge research, to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility, and values diversity and inclusion in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees opportunities for growth, both at work and in their personal lives. Responsibilities The Associate Protocol Manager (PTM) is a diverse and challenging role within Global Clinical Operations working in a dynamic matrix project team. The Associate PTM supports the successful and timely execution of in-house or outsourced clinical research protocols from study start-up to final clinical study report within established budget and timelines. The Associate PTM works in collaboration with the primary Protocol Manager to monitor protocol progress, address and manage obstacles, and help coordinate the development of protocol level documents and plans. The Associate PTM can effectively identify issues and risks, and escalates promptly within the protocol team. The Associate PTM must leverage her/his strong interpersonal and influencing skills to foster partnerships across assigned projects and multidisciplinary teams. Requirements A minimum of a BA or BS Degree with 2 to 4 years of demonstrated project management experience of which at least 1 should have been gained in the pharmaceutical or healthcare industry. Experience working with CROs is a plus. This candidate should have experience in the execution of clinical research trials management demonstrating strong project management and organizational skills.

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Research Scientist, In Vivo Pharmacology

new3 days ago
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The qualified candidate is a highly motivated, interactive, and creative individual that possesses the ability to work across a highly matrixed environment to advance preclinical drug development programs from target identification/validation through IND enabling activities. The candidate will be expected to effectively collaborate with colleagues in the Discovery Oncology, immunology, protein engineering/antibody development and medicinal chemistry groups. The successful candidate will demonstrate clear and professional verbal and written communication, capable of presenting scientific results to multidisciplinary teams and key stakeholders. Candidate requirements A B.S. with a minimum of 7 years, or an M.S. with a minimum of 5 years of industrial experience with strong scientific knowledge and research experience in in vivo pharmacology, cancer biology, immuno-oncology, or immunology is highly desirable. Extensive knowledge of preclinical drug development including demonstrated knowledge of independently designing, executing, and analyzing data from in vivo studies with tumor bearing mice is required. Experience with syngeneic tumor models is preferred; experience with GEMMs is a plus. Required skills include: tumor model development, tumor implantation, animal identification and randomization, dosing via IV, IP, SC, I-TUMOR and PO routes, tumor measurements by caliper, blood draws by tail vessel micro-sampling, cardiac puncture and tissue/tumor collection at necropsy including fixation, freezing and tissue disaggregation to support ex vivo analyses. Experience utilizing multi-color FACS to characterize tumor infiltrating lymphocytes is desirable. Proficiency in cell culture and ex vivo techniques such as qPCR, ELISA (MSD), or WB is required. Experience with surgical procedures to enable development of orthotopic tumor models and using ultrasound to monitor orthotopic tumor growth is desirable. Experience conducting in vivo pooled genetic screens is desirable. Proficiency in utilizing software such as Graph Pad, Microsoft office etc. for data analysis and figure generation is required. Ability to mentor junior scientists and colleagues on best practices in the laboratory would be highly valued. Attention to detail with excellent organizational and record keeping skills is a requirement. Ability to thrive as a member of a diverse and motivated team of researchers spanning across the Oncology Discovery group is a requirement. Responsibilities include Independently design and conduct mouse in vivo pharmacology experiments, including but not limited to model development, tumor implantation, animal identification and randomization, dosing via IV, IP, SC, I-TUMOR and PO routes, tumor measurements by caliper, weighing, health monitoring, tissue sampling by fine needle biopsy and core needle biopsy, peritoneal lavage, blood draws by retro-orbital, tail vessel micro-sampling, cardiac puncture and tissue/tumor collection at necropsy including fixation, freezing and tissue disaggregation to support ex vivo analyses. Mentor junior associates on best practices (in vivo and ex vivo). Establish complex orthotopic tumor models. Utilize ELISAs (MSD), qPCR, or WB to monitor biomarkers in harvested tissues. Contribute to the utilization of multi-color flow cytometry to profile the immune infiltrate in harvested mouse tissues. Accurately maintain proper scientific documentation associated with pharmacology studies in an electronic lab notebook. Effectively communicate and present summaries of research results to team members or to a multidisciplinary team of researchers. Work as a member of a diverse and motivated team of researchers spanning across the Oncology Discovery group and other line functions. Rotating weekend, holiday and off-hour on-site responsibilities to support BID/QD dosing will be expected of this position. This position is located in Cambridge, MA. There will be less than 10% travel.

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US Medical Scientist

new3 days ago
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The BMS Medical organization strives to be recognized throughout the world as the most accomplished and respected BioPharma Medical organization. In BMS Medical, you will have the ability to impact the lives of patients by developing and ensuring the safe and appropriate use of our medicines. Medical increasingly plays a valuable and unique role in unlocking the full potential of our scientific and medical innovation. Medical bridges clinical development with clinical practice and gains broader knowledge of the healthcare industry. Summary This role is a member of the Immuno-Oncology Medical Team, accountable for the Lung/H&N/GBM/B&D investigator sponsored research (ISR) book of work. The individual will work under the guidance of the ISR leads, collaborating closely with multiple matrix teams across BMS and external investigators. Critical Responsibilities Include Partner with US medical team and internal stakeholders to support execution of Lung/H&N/GBM/B&D investigator-sponsored research (ISR) Collaborate with clinical operations and Field Medical teams to track ISR performance Perform due diligence for ISR proposals Provide input on ISR protocols and protocol amendments Review for scientific accuracy abstracts and publications submitted from ISR studies Manage team databases/overviews of ISR BoW and unmet need trackers Partner with Field Medical to coordinate ISR-related engagement of investigators Support planning and execution of US Thought Leader engagement Maintain working knowledge of the treatment landscape, including competitors' plans with ability to integrate into the overall Medical Plan for the product/disease Qualifications Advanced degree (PharmD, PhD, MD, RN, PA) with clinical and/or industry experience. Therapeutic Area (Oncology) scientific & clinical knowledge. Strong analytical skills, with an ability to evaluate scientific data and medical literature, and the ability to extrapolate to medical, marketing, or sales programs. Healthcare landscape knowledge and insight. Strong problem solving skills. Ability to collaborate and cooperative in a complex matrix environment. Ability to work effectively with cross-functional teams, including clinical, marketing, and R&D.

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Principal Scientist

new3 days ago
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Principal Scientist in Cellular Immunology Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Job Responsibilities The successful candidate will be responsible for leading independent project(s) in the areas of immunological intervention of autoimmune diseases. As a part of the matrix team leadership in this area, this leader will be a key immunology representative on various pre-clinical small and large molecule drug discovery teams. She/he will advise and execute the in vitro and ex-vivo discovery immunology experimental plans. As part a larger project, s/he will also interface with other key functions, such as DMPK, Tox, Chemistry, antibody and protein discovery etc. Responsibilities also include scientific management of and working closely with her/his direct report immunology scientists. This individual will report to Immunology Group director; required to lead independently with minimal scientific supervision. Job Requirements The successful candidate will have a PhD in Immunology with 10-15 years of postgraduate work experience, substantial portion of which would be in biotech, Pharma or biopharma setting. At least 3-4 years of post-doctoral training in reputed immunology lab, and publications in key immunology journals are required. Specific expertise in one or more areas of adaptive and innate cellular immunology: such as myeloid biology or immune tolerance expertise will be important characteristics to have. This position requires extensive technical experience with primary immune cell-based functional assays such as primary cell differentiation, proliferation, cytokine measurements, receptor binding and occupancy, and cellular signaling using appropriate biochemical and pharmacological techniques. This position requires extensive technical experience using latest flow-cytometry analysis and sorting techniques, and a working knowledge of bioinformatics. Evidence of supervisory responsibility in academia or industry, and/or project leadership, with crisp communication skills and evidence of a publication record in peer reviewed immunology journals will be key differentiators in candidate selection.

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Associate Director, Planning and Execution

new3 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. The Associate Director, Planning and Execution reports to the Director, Global Clinical Trial Planning & Operational Execution who is a member of the Global Clinical Trial Planning & Alliance Management leadership team within the Global Clinical Operations (GCO) organization. Specifically, the Associate Director, Planning and Execution is accountable for: Partnering with BIA, Operations Leads, Hub Managers and other stakeholders to lead the execution of clinical trial feasibility and governance of global country and site allocation aligned with Regulatory, Medical and Commercial asset strategy and portfolio prioritization within assigned tumor types or disease areas. Partnering and supporting the development and implementation of data-driven, holistic processes and tools to optimize clinical trial site selection across GCO. Strategically expands BMS' pool of sites and investigators. In partnership with BIA and internal stakeholders, synthesize, interpret, and integrate data and information to provide clear recommendations and strengthen data-driven decision making by GCO leaders. Providing leadership and support to ensure effective cross-asset planning to minimize internal competition and saturation in disease areas and maximize enrollment and recruitment potential of studies and programs. Ensure resources are applied to the most critical programs and provide decision support for internal trade-off and prioritization activities. Monitoring overall program health and ensure risks and issues are evaluated and appropriately captured in systems, tools and escalated through reporting pathways. Contributing to the development of clinical operational strategy to help shape the clinical development plan. Developing productive working relationships with key stakeholders throughout BMS with the ability to think strategically and effectively express his/her views. Representing Clinical Trial Planning & Operational Execution as needed in matrix forums, strategic teams or committees (preparatory materials, direct participation, or representative). Working with management to foster a culture of core business understanding across a global organization whose focus is in clinical trial execution. Engaging and energizing employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities. Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability. Experience and expertise required: A minimum of a Bachelor's Degree is required. A degree in Life Sciences or equivalent is preferred. At least 8 years clinical trial operations experience is required. Robust understanding of the drug development process and global clinical operations with a strong understanding of clinical trial feasibility is required. Experience in matrix management is desirable with the ability to engage and inspire others. Good communication skills with a proven ability to effectively engage and manage key internal stakeholders in various functions and geographies. Good presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner. Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills. The candidate will demonstrate the ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with speed, accountability and integrity, and to have fun along the way.

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Senior Research Investigator I, Lead Discovery & Optimization

new3 days ago
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Job Description The Senior Research Investigator I at Leads Discovery and Optimization (LDO) will join a team located in Cambridge, Boston to develop and transfer high throughput assays for target ID and Validation, hit identification and Lead optimization. The group will work in close proximity to Oncology Biology, Translational Medicine, and Molecular Discovery Technology at Cambridge with a mission to discover and develop innovative Immuno-oncology and Oncology pipelines. The qualified candidate is a highly motivated, interactive, and creative individual that possesses substantial experience in studying tumor biology and genetics, especially with hands-on experience with the CRISPR technology. The ideal candidate should effectively collaborate with colleagues in the oncology discovery group for target ID and target validation with a goal to apply CRISPR technology to the functional genomic screening. In addition, this candidate will be included in Drug Discovery working groups and support lead optimization efforts at CAM site. The successful candidate will demonstrate clear and professional verbal and written communication, capable of presenting scientific results to multidisciplinary teams and taking a strong leadership role in the matrix organization cross Discovery functions including LDO. The candidate will develop external partnerships/collaborations to advance CRISPR technology together with the core team in NJ. This individual will demonstrate the ability to contribute to various projects outside of his/her own, and collaborate with stakeholders from all relevant functions. S/he will keep up-to-date in the literature related to his/her field, act as an expert resource in his/her scientific field and in related disciplines, and propose new therapeutic targets. This position is located in Cambridge, MA, reporting to the LDO site leader at CAM. Qualifications Required A Ph.D. degree with 5 years post-doctoral experience in cancer biology and genetics or a closely related field A proven track record in the field of cancer biology and genetics, as evidenced by publication record Demonstrated ability to design in vitro and in vivo systems, assays and flowcharts to identify and optimize drug candidates; key technical skills include proficiency in CRISPR, functional genomic screening and complex cellular assay development. Excellent interpersonal skills with the ability to interact effectively with people, internally and externally Excellent oral and written communication skills Able to effectively present scientific data and concepts to international standards Familiar with HT screening technologies platforms Reports: 1 to 2 Research Scientists/Associates

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Clinical Trial Lead, Fibrosis, Innovative Medicines Development

new3 days ago
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Summary The Clinical Trial Lead works with stakeholders across the organization to design and implement strategically aligned, efficient clinical trials that meet ethical, scientific, safety, regulatory, and commercial objectives. The Clinical Trial Lead reviews and interprets clinical data, guides appropriate recommendations and decisions, and contributes substantially to regulatory submissions. This position is based in Lawrence Twp., New Jersey (PPK) Responsibilities Works with matrix team members and partners to translate development team strategy into protocols and action plans. Works with the relevant team members and partners to develop clinical protocols and related documents, including clinical study reports, clinical regulatory documents including integrated summaries and clinical overviews. In collaboration with pharmacovigilance, designs and implements safety monitoring plans. Provides key contributions to clinical documents and deliverables in support of regulatory submissions. Monitors one or more clinical trials for safety and experimental rigor. Reviews and cleans data from clinical trials. Addresses relevant clinical queries from study sites and authors responses to study related IRB and HA questions. Cultivates relationships with thought leaders and investigators, and gathers input on disease areas and design of clinical programs. Provides clinical support to medical affairs and commercial colleagues. Qualifications MD, PhD, or MD/PhD required, preferably with a deep understanding of fibrotic diseases and immunology. Expertise in pulmonology and/or critical care preferred. At least 5 years of experience in clinical or translational research or in clinical practice in a relevant field. Expertise in implementing scientific methods to test hypotheses, design, analyze, interpret and report results. Understanding of the fundamentals of protocol development and execution, including but not limited to study monitoring, data collection and analysis, database cleaning and database lock. Understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements. Ability to work consistently in a matrixed environment with relevant teams such as operations, statistics, regulatory, pharmacovigilance and biomarkers. Ability to lead multiple complex projects in parallel. The candidate should have excellent communication skills and experience delivering effective presentations on both technical and nontechnical subjects.

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Clinical Trial Lead, External Clinical Collaborations, Oncology Clinical Development

new3 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. The Grade/Level of the Role Will be Determined by the Qualifications and Experience of the Chosen Candidate Responsibility for execution of clinical collaborations between a BMS development compound and another company's asset: Be accountable for the design, execution, and analyses of appropriate clinical trials to test scientific hypotheses and enable further development of combinations. Lead individual collaborations, including managing input from other members of the Matrix team (Clinical Operations, Regulatory, Translational Medicine, GBS and Clinical Pharmacology) Implementation of clinical collaboration once agreement executed. Monitor progress of combination trials with BMS assets under clinical collaborations, and analyze and report ongoing progress and outcomes within his/her scope to I-O Development teams and Governance bodies In collaboration with GRS and GPVE, monitor safety of collaboration trials and prepare regulatory documents as needed Work with publications and medical to develop publication plans for each collaboration and lead authoring and review of abstracts, presentations, and manuscripts Active contributor on Business Development (BD) and External engagement activities: Represent Clinical Oncology at select Bio and scientific conference meetings with external companies Together with Alliance Management, establish strong partnership and interfaces with existing collaboration Together with BD Search and Evaluation, evaluate incoming clinical collaboration proposals and participate in active searches for collaboration partners to address areas of strategic importance Participate in clinical contributions for due diligences, M&A analyses, and clinical development plan (CDP) generation Work closely with key BD partners (Alliance Management, Finance, S&E, etc.) to ensure execution and overall quality of External Collaborations and related relationships. Represent Oncology Clinical Development in both internal and external forums. Be familiar with and potentially contribute to the development plans of programs within assigned FDT(s) and their current statuses Assess, navigate and integrate inputs from key internal disciplines and stakeholders, especially functional and clinical Program Leads. Participate in internal cross-functional working groups May also provide medical and scientific expertise to BMS colleagues in drug discovery, labeling, regulatory, outcomes research, and marketing/commercial departments. Desired Background and Experience Substantial clinical research experience (relevant academic research experience could potentially substitute) Has a deep understanding of the fundamentals of protocol development and follow up, including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock Has a history of handling multiple, complex, studies in parallel Has a history of prior meaningful participation in regulatory submissions Has a history of strong interactions with thought leaders Has a history of successful external stakeholders management Proven ability to work within and potentially lead a matrix team Performs as an individual contributor MD preferably with a background in clinical oncology; PhD, Pharm D or other health related scientific field with a deep understanding and direct experience in oncology clinical development. At least 6years of relevant experience. This position will be based in the Princeton, NJ area.

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Protocol Manager

6 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Summary NRDG Protocol Manager will provide end-to-end management of Non-Regulatory Data Generation (NRDG) clinical research. They will provide operational expertise and will focus on studies including Investigator Sponsored Research & other study types. Protocol managers act as a matrix leader for operational support team(s) and are accountable for the timely execution of NRDG trials. Responsibilities A GCO NRDG Protocol Manager will provide end-to-end management of Non-Regulatory Data Generation (NRDG) clinical research. They will develop expertise in a disease area (oncology or specialty), and focus on studies including Health Economics and Outcomes Research (HEOR), Investigator-Sponsored Research (ISR), Expanded Access Programs (EAP), Non-Clinical Research (NCR) and some late-stage interventional research. Protocol managers act as a matrix leader for the Study Management Team and are accountable for the timely execution of NRDG. Drive the successful and timely execution of medical-affairs trial work. Including investigator sponsored trials from study start-up, to final study report within the established timelines and budget Support of the cardiovascular/oncology/immunoscience therapeutic areas and experience with managing these therapeutic areas for Medical affairs trials (eg: HEOR, ISRs, Late Phase). Manages complex and varied study types across a matrix organization. Responsible to manage applicable clinical trial management systems to track metrics, timelines, and other data to assure Protocol and/or Program quality/compliance, timelines and budget are managed according to expectations. Facilitates identification and prompt escalation of project risks and issues along with mitigation / resolution strategies to appropriate stakeholders and/or functional management, to expedite resolution. Proactively analyzes and drives efficient problem solving within team's control. Applies critical thinking to manage complex issues. Effectively leads team in collating information for operational reviews, highlighting issues and risks, developing mitigation and resolution strategies, and promptly responding to action items. As applicable, supports protocol budget negotiations, contracts and other study costs with sites As applicable, collaborate with regulatory to secure authorization letters to submit to regulatory agencies for IND submissions and/or cross reference letters Collaborate with Drug Supply to project clinical supply needs based on projected site activation and enrollment Builds strong relationships and encourages collaboration with team members and internal and external stakeholders across organizational, functional, and geographic boundaries to achieve project and/or program deliverables. Creates synergy with stakeholders and develops strong alliances and teamwork with Medical, Operational leadership, field medical, drug supply, and other team members. Effectively leverages network of internal and external contacts. Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process. Strong understanding of GCP, ICH and regulatory guidelines as they apply to protocol management and program strategy. Understands the influences of safety and efficacy profiles, labeling, legislation and marketing on the life cycle of a compound. Effective oral, written and interpersonal communication skills Experience with conflict and issue management. Ability to learn new technology and effectively use Clinical Trial Management Systems (CTMS) and other technology platforms. Demonstrated ability to multi-task and manage high performance demands. Qualifications Minimum education BA/BS required. Prefer individual with strong science background with a minimum of 5 years of demonstrated complex trial management experience in the pharmaceutical or CRO (or equivalent) industry Prefer individual with a minimum of 5 years of demonstrated NRDG (ISR) experience

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Clinical Trial Associate

6 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. This position manages administrative and business activities to support the regulatory and procedural requirements necessary for US investigative trial sites to conduct clinical trials, with accountability of executing these activities from study start-up to study closure. Responsibilities: Independently manages multiple site level deliverables during start-up, maintenance and closure both within BMS and external business partners and vendors, when required. Collaborates directly with the BMS internal study teams, external site staff or both to ensure management and alignment on BMS business processes and execution of study timelines. Manages and makes decisions on the development and execution of study related binders and coordinates relevant study materials at study start-up. Drives the collection and review of site regulatory documentation directly from US sites in accordance to SOPs, GCP and regulatory guidelines. Responsible for site level source documentation within the Clinical Trial Master File; Ensure accuracy and completeness of the trial master file in preparation for audit and inspection. Executes all appropriate business processes to ensure Clinical Trial Package completion for drug shipment is achieved. Trains and develops US clinical site staff in the execution of regulatory documentation. Minimum Requirements: Bachelor's degree in nursing, life science or healthcare related field or equivalent work experience 1-3 years' experience in clinical research or related work experience Knowledge of ICH/GCP Guidelines and local regulatory guidelines or regulations preferred Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent. Ideal Candidates Would Also Have: Additional complex software application related to clinical trial research (i.e. electronic data capture or patient diaries, interactive voice response, etc) Other qualifications: US military experience will be considered towards industry experience requirements

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Clinical Trial Associate

11 days ago
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Bristol - Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients

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Pharmaceutical Development Technician

11 days ago
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This position is needed to manufacture clinical supplies. Tasks for the function: Adheres to the established manufacturing schedule for all assigned batches from start to completion. Assists in the manufacture of pharmaceutical oral dosage products for use in clinical studies. Follows all written procedures, SOPs, cGMP regulations and safety requirements during manufacturing. Carries out operations with strict adherence to cGMP and OSHA requirements. Participates in all manufacturing activities of assigned batches and completes all required documentation. Performs equipment setup, batch execution including completion of associated batch documentation and equipment logs and equipment cleaning. Enters data into computer terminals when required. Education Requirements: Two-year Associate Degree in Science related to pharmaceutical development or equivalent. Proficiency in use of computer programs/systems is essential. Technicians must maintain their skills and knowledge current with advances in the field of pharmaceutical development. Incumbents may attend internal or external training courses as approved by management.

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Principal Scientist, Cancer Drug Discovery

11 days ago
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This Principal Scientist position will join the Cancer Resistance Biology Research Team at Bristol-Myers Squibb in Cambridge, MA to lead preclinical drug development against therapeutic targets at the intersection of intrinsic tumor genetics and the extrinsic tumor microenvironment. Summary The qualified candidate is a highly motivated, interactive, and creative individual who possesses substantial experience in studying tumor biology and genetics, and experience or strong interest as to how these features impact immune responses to the tumor. The candidate will be an experienced program team leader and drug hunter. S/he will be an effective manager and mentor to more junior PhDs and associates. Since BMS is a matrixed organization, the candidate will be expected to effectively collaborate with colleagues in supportive line functions (including oncology, immuno-oncology and immunology, medicinal chemistry, candidate optimization and translational medicine) to advance preclinical development of therapeutic candidates to early clinical development. The successful candidate will demonstrate clear and professional verbal and written communication, capable of presenting scientific results to multidisciplinary teams, senior management and at external scientific meetings. The candidate will develop external partnerships/collaborations to advance internal programs, as appropriate. Similar they will be involved in the evaluation of partnering and other business development opportunities. S/he will be responsible for building and supervising a group of up to 2 PhD Investigators and 4-6 research Scientists/Associates. There will be less than 10-20% travel. Qualifications Required A Ph.D. degree with 8- 10 years of relevant industrial experience in cancer biology and genetics, immnuo-oncology or a closely related field Industry experience with demonstrated abilities to drive preclinical development from target ID to clinical candidate selection, especially experience in small molecule drug discovery A proven track record in the field of cancer biology and genetics, as evidenced by publication record Demonstrated expertise to independently apply bioinformatics and data mining through multi-variate analysis; ability to effectively interact with core bioinformatics colleagues, as well as to use desktop tools/interfaces and public databases Management/supervisory experience is essential. Excellent oral and written communication skills, as well as the ability to effectively present scientific data and concepts to international standards. Preferred Experience or the ability to innovate in novel preclinical in vitro , in vivo and ex vivo oncology model development that enables bridging from tumor biology to host immunity Experience in studying the tumor stromal compartment Ability to effectively interact with core bioinformatics colleagues, as well as with translational research scientists to generate testable hypotheses for targetable nodes that drive cancer resistance to current immuno-therapies. Reports 1-2 PhD Investigators, 4-6 Research Scientists/Associates

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Cardiovascular Medical Scientist

11 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Responsibilities: As lead for NVAF strategy, the incumbent will partner closely with key internal stakeholders, including WW Medical, US and WW Commercial and the Alliance Partner to develop strategic plans and to execute medical plan related to NVAF. Manages 1-2 Eliquis Medical Scientists Cooperates with cross-functional medical team members to deliver key medical activities related to NVAF, including advisory boards, congresses, proactive messaging, reactive medical communication, publication strategy. Anticipates needs of field medical team, including training and content Effectively partners with commercial organization on both strategy and execution related to NVAF and in light of evolving healthcare landscape. Engages with external Thought Leaders to gather insight into unmet medical needs and educational gaps related to diagnosis and treatment of NVAF. Leads the annual medical strategy planning process and works closely with Medical Lead to ensure coordinated execution of the plan by members of the extended US Medical matrix team. Qualifications: MD/PharmD/PhD or equivalent degree with experience in cardiovascular disease and/or thromboembolic disease. At least 10 years of clinical experience in cardiovascular or thromboembolic disease or industry experience in research and development or medical affairs is preferred. Experience working within an Alliance or Joint Venture would be extremely desirable. Critical thinking skills related to data are a must. Strong interpersonal and communication skills. Proven leadership in managing complex interactions and gaining alignment of stakeholders.

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Associate Director, I-O Medical Scientist, GI

11 days ago
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The BMS Medical organization strives to be recognized throughout the world as the most accomplished and respected BioPharma Medical organization. In BMS Medical, you will have the ability to impact the lives of patients by developing and ensuring the safe and appropriate use of our medicines. The Medical organization plays a valuable and unique role in unlocking the full potential of our scientific and medical innovation. Medical bridges clinical development with clinical practice and gains broader knowledge of the healthcare industry. The US I-O Medical Scientist and tumor lead for GI cancers plays a critical role in forging broadly aligned tumor strategies, translating them into tactical plans, and leading the execution of these plans. Critical Responsibilities include Demonstrate forward thinking by understanding emerging trends, anticipate future obstacles, risks, and business opportunities, and proactively create strategies, tactics, and contingency plans Collaborate with GI Development and Headquarter Medical teams in the development of long-term tumor strategies Lead the US cross-functional medical matrix teams in the development and execution of US medical plan Partner with US Commercial & Access organizations to integrate medical perspectives into the commercialization process and ensure appropriate alignment between commercial and medical Contribute to shaping the competitive strategies by communicating the US perspective for the target product profile, label language and value considerations Be the content expert of the assigned tumor, lead the development of field resources, and conduct effective training for field teams Identify data gaps, develop strategies for US non-registrational data generation, and lead the review, approval, and timely execution of investigator sponsored research Develop and maintain long-term, trusted relationship with external thought leaders and investigators Requirements Advanced scientific degree (MD, PhD, PharmD) Prior pharmaceutical industry experience in medical or clinical research Familiarity with all phases of oncology drug development, including clinical development, regulatory and life cycle management, is desirable Therapeutic area scientific & clinical expertise is desirable Experience in leading complex projects and diverse, high performance teams Strong interpersonal skills to navigate complex situations and build alignment with key stakeholders Demonstrated ability to execute and deliver results in a deadline-driven environment Clear and effective verbal & written communication skills Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D Qualifications Experience in pharmaceutical industry.

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Proteomics Research Scientist

11 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. We seek an experienced, talented, highly motivated and detail-oriented Proteomics Research Scientist with proven track record to join the Proteomics group within the Discovery Research organization at BMS. This is a laboratory based position, reports directly to the Proteomics Principal Investigator and ultimately to the Head of Proteomics within the Genomics organization. The candidate is expected to work effectively in a highly collaborative matrixed environment, interfacing with oncology, cardiovascular, and fibrosis discovery to bring to bear proteomics techniques to tackle complex biological questions. The candidate needs to have a proven track record and experience in successfully applying proteomics to either discovery or translational space. Hands on laboratory experience in utilizing proteomics methodologies as well as contextual optimization methods to fit study needs is required. Experience with latest proteomics mass spectrometry techniques / workflows to characterize complex proteomes to enable translational and clinical research activities is absolutely necessary. Experience with effective utilization (including basic maintenance) of proteomics analytical instrumentation (latest generation, nano-chromatography and mass spectrometry) and associated data handling software interfaces is a must. Experience with proteome level post-translational modification analyses (e.g. glycosylation, acetylation/methylation) would be a plus but is not necessary. Experience or working knowledge of proteomics design of experiments, LC/MS proteomics data processing and subsequent data analyses is required. Experience with automation and laboratory instrument data management is desirable. Deep proficiency in applying classical protein biochemical techniques as well as updated proteomics techniques (protein fractionations, chromatography etc.) is absolutely necessary. Familiarity with basic cell culture techniques and standard molecular biology techniques is highly desirable. Additionally, experience with handling human as well as animal biomatrices (including tissues, plasma ) is highly desirable. Overall, excellent lab skills and lab etiquette are crucial and required to be successful in this position. The candidate must have expertise with clearly drafting lab work practices and maintain regular scientific records in terms of laboratory notebooks. The candidate should be proficient with workplace software tools (word processing, excel, presentation etc.). Qualifications B.S. /M.S. in Biochemistry, Analytical Chemistry, Life Sciences, or related field including a minimum of 4 to 8 years of relevant proteomics experience. Scientific creativity, innovation and resilience are absolutely necessary to be successful in this position. A record of scientific productivity documented in peer reviewed journals is highly desirable. The candidate should have a strong interest in drug discovery research. The individual should possess ability to handle multiple projects, closely collaborate & matrix with scientists within the group and across Translational Medicine and Discovery organization. The candidate should have effective organization and presentation skills; be reliable, highly motivated, have strong interpersonal communication skills and embrace working in a team/matrix environment. The candidate should possess strong personal attributes of integrity, perseverance in face of challenges, and ability to tackle complex problems.

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Research Scientist, Drug Discovery

12 days ago
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The Research Scientist Biology will join the Oncology Resistance Biology group at Bristol-Myers Squibb in Cambridge, MA and support the preclinical drug discovery and development of early stage therapeutic targets at the intersection of tumor genetics and tumor immunobiology. The qualified candidate is a highly motivated, interactive, and creative individual that possesses the ability to work across a highly matrixed environment to advance preclinical drug development programs from target identification/validation through IND enabling activities. The candidate will be expected to effectively collaborate with colleagues in the oncology, immunology, immuno-oncology, protein engineering/antibody development and medicinal chemistry groups. The successful candidate will demonstrate clear and professional verbal and written communication, capable of presenting scientific results to multidisciplinary teams and key stakeholders. Qualifications A B.S. with a minimum of 7 years, or an M.S. with a minimum of 5 years of industrial experience with strong scientific knowledge and research experience in cancer biology/cellular and molecular biology is required. Experience in immune-oncology research is a plus. Demonstrated independence in experimental design, execution, data analysis and troubleshooting is required. Knowledge of preclinical drug development including knowledge of designing assays and flowcharts to identify and optimize drug candidates is required. Hands on experience with a wide range of in-vitro cellular and biochemical assays such as cell culture, cell line engineering, western blotting, immunoprecipitation, ELISAs (MSD), reporter assays, and high content imaging Experience with multi-color FACS or ex vivo pharmacology (e.g. histoculture) is highly desirable. Proficiency in utilizing software such as Graph Pad, Microsoft office etc. for data analysis and figure generation is required. Ability to mentor more junior scientists and colleagues on best practices in the laboratory would be highly valued. Attention to detail with excellent organizational and record keeping skills is a requirement. Excellent interpersonal skills with the ability to interact effectively with people, internally and externally is required. This position is located in Cambridge, MA. There will be less than 10% travel.

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Clinical Trial Lead - Oncology Development

12 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. JOB DESCRIPTION Work with the BMS ONO I-O Joint Development Team Leader and JDT matrix team members to enable the global oncology strategy to be executed in Japan, Korea and Taiwan. Review and communication of strategy, medical data, trial designs, protocol amendments, regulatory updates, study timelines and other information relevant to the BMS-ONO oncology book of work Work consistently in a matrix environment MD, PhD, Pharm D or other health related degree in scientific field with an understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge. The position is based in the Princeton, NJ area. JOB REQUIREMENTS ROLE IMPERATIVES This role will be a key contributor to BMS/ONO I-O joint development in Japan, South Korea, and Taiwan of collaboration assets including regular development meetings, management of collaboration book of work, and regional specific strategy. Active member of JDT matrix core team, which includes Clinical, Operations, Project Management, Regulatory, Alliance Management and Finance, including responsibility with project manager for action items and key follow-up activities. Work with Program Leads, team members and internal governance bodies to translate the FDT strategy into trial options, protocols and action plans Work with Program Leads and CTLs on tumor teams to prepare and regionally tailor materials for external JDT and other BMS-Ono governance and interactive forums A close relationship with BMS's Japan, Korea and Taiwan R&D will be important. This individual will work closely with Translational Medicine (TM), a rapidly expanding area of growth in connectivity between Ono and BMS; particularly as it relates to pan-tumor, pan-trial, and exploratory activities including but not limited to TMB, PD-L1, GEP and other emerging biomarkers and CDx. Help organize BMS-Ono events including face-to-face clinical forums (e.g. design agenda, prepare materials with clinical teams, logistics coordination) As needed, support Program leads to produce clinical protocols and related documents (CRF, DRP), including Clinical study reports, clinical regulatory documents including integrated summaries and clinical overview; support generation and coordination of clinical documents and deliverables in support of regulatory filings The role may also include support of general contributions to OCD (PSC, CTL Forum, etc.) May require some travel to Japan and the region as required in support of this close partnership and in support of key joint development committees. The role will report directly to the BMS ONO I-O Joint Development Team Leader ESSENTIAL LEADERSHIP BEHAVIORS Maintain a strong medical/scientific reputation across oncology Build and maintain strong relationships across BMS matrix, including general understanding of non-clinical components of development teams (regulatory, operations, etc.) Share specific clinical strategies with other clinical teams Study-specific clinical design and execution Manage communication with key stakeholders DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE Understanding of the fundamentals of clinical development (including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock) Clinical research experience (or related function, including those like Medical or Commercial who partner with clinical) Has a history of handling multiple, complex, studies in parallel Plans strategically - Anticipates, identifies and addresses issues in a proactive way and then partners on cross-functional teams to come up with solutions. Has a history of strong interactions with external stakeholders Performs as an individual contributor with some comfort working independently Identifies when an issue is present and begins to address Translates strategic input into concrete options. Participates or leads an above project work stream Peer mentors and contributes to onboarding of new talent Exhibits elements of BMS leadership capabilities

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Senior Validation Scientist - Cleaning Validation

13 days ago
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Summary: Accountable for the design, performance and documentation of validation studies for products manufactured at the pharmaceutical manufacturing sites. This includes the processes, formulation and equipment used in the manufacture of solid and Parenteral products and all related systems, utilities, and services needed to support the manufacturing activities. This position must comply with all Security guidelines, Environmental, Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Major Duties and Responsibilities: 1. Prepares well-documented protocols for all processes to be qualified/validated based on corporate guidelines, procedures, FDA Regulations, and Industry current practices. 2. Coordinates the validation activities with related departments (Engineering, Manufacturing, QC/QA, Technical groups) 3. Develops and controls detailed time and event schedules for all studies/projects assigned. 4. Performs qualification/validation studies as per established protocol. 5. Reports in an accurate and timely manner all the studies/project assigned in accordance with the designed protocol. 6. Evaluates process/equipment performance during the studies in order to determine acceptability, reproducibility, and control. 7. Provides timely and efficient technical support to user on qualified/validated systems/processes. 8. Maintains all documentation records in accordance with cGMP's, company policies and FDA regulations. 9. Maintains an understanding of the current technical and regulatory trends in the pharmaceutical industry. 10. Proposes and formalize alternatives for enhancement to validate a process. 11. Maintains validation programs in conformance with department standards and government/corporate regulation/specification. 12. Utilizes statistical tools and other techniques to assess performance of validation studies. 13. Assists management during FDA inspections by interacting with FDA/auditors during inspection or audits. 14. Provides annual revision of the validation programs covered in the validation Master Plan. 15. Update Operational procedure of equipment/system validated according to actual results. 16. Train impacted personnel by updated operational procedure. 17. Collaborates with internal /external clients as requested and or permitted by immediate supervisor. 18. Provides backup support to the section Associate Director during his/her absence and makes section decision as needed. Knowledge/Skill/Education: • Bachelor Degree in Pharmacy, Chemistry or Chemical / Mechanical Engineering or any other related Science field. • Five (5) years of experience in pharmaceutical manufacturing processes, technologies and aseptic processing equipment for Parenteral and biological dosage forms. • Three (3) years of experience in pharmaceutical technology transfer, process improvements and troubleshooting. • Proficient knowledge of biopharmaceutical formulation processes, Parenteral filling and syringe filling processes. • Proficient knowledge of product and process development, manufacturing scale up, continuous process improvement and troubleshooting processes in conformance with departmental standards and in compliance with regulations. • Detailed understanding of how Parenteral manufacturing processes are controlled and validated. • Ability to effectively manage multiple projects at the same time with minimum supervision and to incorporate a wide array of technical principles, concepts and theories in innovative ways to technology transfer and scale-up activities. • Strong project management skills. • Proficient time management skills, planning and organization capabilities. • Proven ability to influence and work with people at different levels and departments. • Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups. • Proficient in Statistical Process Control, Process Capability and Risk Assessment/Management • Proven assessment, analytical and problem-solving skills. • Proficient presentation skills and Technical Writing/Oral communication skills (English/Spanish) • Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry. Cleaning validation for manufacturing equipment in-depth knowledge and experience is required

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Associate Director Clinical Pharmacology

13 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Position Description and Responsibilities : This individual will apply their Clinical Pharmacology and Drug Development expertise to the development of small molecule and biologic assets in Marketed Products that help patient prevail over serious disease conditions including cardiovascular disease and virology. This person will play a central role in the planning, design, execution, interpretation of reporting healthy subject and patient studies conducted in early, full and life cycle stages of development. You willl also provide broad Pharmacometrics (PhMtrx) strategic leadership to early and late stage assets. Provide critical input on the design and execution of Clinical Pharmacology plans and be able to create a robust human Clinical Pharmacology profile by integrating results from a broad spectrum of non-clinical, clinical and model-based assessments. In addition, you will be responsible for generating modeling and simulation (M&S) plans and conducting population pharmacokinetic and exposure-response analyses for the assets. This individual will serve as the Clinical Pharmacology subject matter expert on cross functional asset teams and provide his/her functional expertise during health authority interactions and regulatory submissions. Position Requirements : The requirements for this position include Ph.D.in pharmacology or pharmaceutical sciences, or a PharmD with a clinical pharmacology research fellowship. A minimum of 5 years experience gained through direct industry experience in Clinical Pharmacology is required. The person that fills this role will have experience in the hands on modeling and application of quantitative clinical pharmacology including, pharmacometrics and other model-based approaches to guide drug development. Extensive knowledge of the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation and reporting is a prerequisite. Experience of working on the development of both small molecules and biologics is highly desirable. The successful applicant should have experience in providing input on clinical pharmacology plans and the preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs). She or he will have knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, pharmacodynamics, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, toxicology. Strong oral and written communication skills necessary to formally present and report information internally and externally is required. The ability to work in a dynamic team oriented environment is essential.

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Environmental Scientist/ Geologist II

15 days ago
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As an Alaska-Native owned company, Bristol companies seek out and hire qualified Alaska Natives and other minorities. Education Bachelor's Degree in Chemistry, Environmental Science, Biology or ...

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Research Investigator II - Separation Science

16 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. The Discovery Chemistry team is looking for a hands-on analytical scientist to provide separation support for discovery of synthetic drug molecules in a team environment. The position will involve performing chromatographic separations for analysis and purification of synthetic molecules in a drug discovery environment, including the use of a variety of chromatographic and detection methods. Primary responsibilities will include: Performing chromatographic method development and analytical separation using HPLC, SFC, CE and GC, including maintenance and utilization of sophisticated parallel SFC and HPLC systems from a variety of vendors including Agilent, Shimadzu, and Waters. Performing preparative scale separation of challenging drug molecules and metabolites using preparative-HPLC or SFC with UV and MS detectors from a variety of vendors including Agilent, Shimadzu, and Waters. Use and maintain specialized separation and detection instruments that including2D UPLC/ToF MS; HPLC/Chemiluminescence Nitrogen Detector (CLND), UPLC/FLD, SEC/MALS/RI, and parallel SFC/UV/CD. In addition, the chosen candidate will assist senior scientists to develop and implement innovative chromatographic and spectroscopic solutions for non-routine problems such as chiral interconversion kinetics and thermodynamics, biomarker assay development, and other special projects. Requirements: The candidate will have a Ph.D. in Analytical Chemistry or a related field with 1-3 years demonstrated experience in relevant biopharmaceutical applications. The following qualifications are required or preferred: Hands on experience in separation science is required, including both analysis and purification using HPLC and/or SFC with a variety of detection methods (UV and MS required). Familiarity with chromatography instrument hardware and software from major vendors (Agilent, Waters and/or Shimadzu) with skills at diagnosis and correction of instrumental and methodological problems. Familiarity with the concepts of modern chromatography, including method development, mobile and stationary phase selection, method optimization, and data interpretation is required. Demonstrated ability to succeed in a highly matrixed multitasking environment, including time management and prioritization is required. Evidence of using strong written and oral communication skills to effectively interface with customers and collaborators with diverse areas of expertise is required. Hands-on experience in maintaining, automating and customizing chromatographic and spectroscopic instrumentation is desirable but not required. Skills in computer programming, modeling and statistical analysis are desirable but not required.

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Regulatory Strategist

17 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Expected Areas of Competence Develop and lead Global Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement. Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans Provide leadership to resolve critical regulatory project issues, bring the appropriate regualtory experts together as needed Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies Provide strategic regulatory input to key development documents and study reports, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents, Analysis Plans and DMC Charters Develop and approve the vendor contracts and relationships required to deliver regulatory documents and dossiers of high quality Provide strategic regulatory input on the target product profile, CCDS, and country-specific label Create an asset specific global HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally, partner with regional / local liaisons to execute interactions Formulate integrated global submission plan for simultaneous filings and take accountability for translating that into operational plans to be delivered by external vendors. Approval of regulatory documents Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines Behaviors Translates broad strategies into specific objectives and action plans that can be effectively executed by external partners. Sets challenging, but regulatory achievable objectives, comfortable taking risk in the regulatory setting Generates alternative regulatory strategies and plans, and assesses benefits and risks. Develops contingency plans and meets challenges necessary to execute business and action plans. Ensures these plans are feasible using external resources. Creates a unified and seamless team using both internal and external resources to execute regulatory strategy Communicates opinions, facts and thoughts with clarity, transparency and honesty Seeks multiple perspectives and listens openly to others' points of views. Enables and demonstrates the courage to speak up on issues and risks as well as on the good news. Demonstrates ownership of results within (and beyond) area of responsibility. Sets clear and high expectations and holds self and others accountable for decisions and results achieved. Develops and applies unique ideas and new methods to achieve higher performance and excellence. Works across organizational, functional and geographic boundaries to achieve company goals. Creates an environment that encourages continuous improvement, innovation and appropriate risk taking. Demonstrates resilience and perseverance. Experiences/Qualifications PhD, MD, PharmD with at least 10 years of relevant regulatory experience Proven success in delivering effective global regulatory strategies in coordination with cinical plans and marketing objectives leading to successful registration. Excellent in communicating regulatory strategy, issues, and risks in written and verbal format Experience leading cross functional matrix teams Demonstrated ability to break down complex, scientific issue and communicating regulatory implications Proven success in negotiating regulatory objectives with HA This position is based in Lawrenceville, New Jersey.

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Laboratory Compliance Manager

18 days ago
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Job description Advice department on the design of testing laboratory processes and activities for enhanced compliance. Accelerate implementation of practice changes in testing laboratories brought by procedure revisions and change management. Apply GMP regulations in an environment that bridges development and commercial manufacturing of active ingredient and medicinal products. Function as expert in laboratory procedures through understanding of their application and authoring. Conduct laboratory investigations and design corrective/preventive actions and grow the laboratory investigator community through measurement. Conduct efforts that build investigation expertise. Drive audit readiness of GMP laboratories. Perform as a department leader in support of the Quality Management System and Quality Risk Management program. Sustain partnership between the GMP laboratories, the Quality Unit and other laboratory collaborators. Desired Experience Required: BS or MS in science, engineering or related field with 5 years' experience GMP laboratories or QA function. Demonstrated ability to influence across departments and sites. Experienced in authoring and revision of procedures Experience with periodic review, change management, supporting audits, and quality management system such as TrackWise. Experience in commercial pharma/biologics manufacturing environment preferred. Experience with tools for root cause identification and best practices in development of corrective actions. Ideal Candidate will also have: Experience with risk assessments associated with data integrity and/or process analytical technology. Advanced user of with Microsoft applications and experience with Share Point Online. Six Sigma certification or analytics software experience is a plus.

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Protocol Management Line Manager

19 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. NOTE: This role may have oversight of either BMS Protocol Managers or FSP Partner Protocol Managers. Responsible for leading and managing Protocol Managers/Clinical Scientists within Strategic Protocol Execution and contributing to the Strategic Protocol Execution leadership team. As applicable , demonstrated competencies in coaching and developing others and supporting department management activities. Strong Project and Change Management skills/good understanding of and ability to successfully navigate systems and processes. Experience with resource allocation, balancing competing resource demands with organizational priorities and experience in financial management and recruiting talent. Demonstrated ability to communicate effectively to achieve deliverables within acceptable time frames and to cooperatively work with others to resolve differences and achieve objectives. Embraces change and effectively implements and supports new processes. Experience in execution of clinical research protocols from study startup to final clinical study report within established budget and timelines using strong project management and organizational skills. Strong interpersonal and influencing skills, proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams, effective oral and written communication skills to influence, inform or guide others. A minimum of a BA or BS Degree with seven to ten years of pharmaceutical industry experience and managing global clinical trials.

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Protocol Manager

20 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Description : Drives the successful and timely execution of a clinical research protocol from study start-up to final clinical study report within established budget and timelines using strong project management and organizational skills, monitors protocol progress and addresses and manages obstacles, serves as primary operational contact for the protocol, coordinates the development of protocol level documents and plans, effectively leads a global team of individuals assigned to the protocol; strong interpersonal and influencing skills, proven team-building skills and ability to foster partnerships across projects and multidisciplinary teams, effective oral and written communication skills to influence, inform or guide others. Comments: Additional PTM support is needed to manage the current BoW for the I-O priority programs. The demand for this program continues to increase with multiple upcoming submissions and an expanding LCM program. Requirements: A minimum of a BA or BS Degree with 4 to 6 years of demonstrated project management experience of which at least 2 should have been gained in the pharmaceutical or healthcare industry. This candidate should have leadership experience in the execution of global clinical research trials management.

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Investigative Toxicologist

20 days ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. Responsibilities: Create novel experimental designs for mechanistic toxicology studies designed to assess hypotheses for and evaluate mechanisms of toxicity related to physiological or biochemical functions. Support predictive toxicology experimental efforts within Discovery (e.g., in vitro cell-culture based, animal models of disease) analyze safety-related data and use it to make decisions. As a Discovery Working Group representative, the individual will develop early safety assessment evaluations and early hypotheses about mechanisms of toxicity, ensure appropriate toxicology studies and liability screens are performed to support nomination of drug candidates for further development. Participate in issue-resolution teams, where she/he will contribute to hypotheses generation and drive the science for toxicology issue resolution in drug discovery and development. Communicate results clearly and concisely in both oral and written reports. Perform in depth pathway/network analysis on data derived from toxicology and other studies and disseminate results to the wider toxicology community (internally and externally). Closely interact with scientists in other functional areas. Qualifications: This position will require broad-based knowledge of toxicology, with emphasis on investigating molecular mechanisms of toxicity. A Ph.D. in toxicology is required, and postdoctoral experience is preferred. This is an entry level or early career position, and no experience in the pharmaceutical industry is required. The candidate should possess strong skill sets related design and implementation of investigative toxicology studies and use of models to support in vivo, ex vivo and in vitro mechanistic translational toxicology studies, with a particular emphasis on comparative biology. The candidate should also have demonstrable competency in directing exploratory toxicology studies that support de-risking of innovative drug targets and modalities and non-clinical compound candidate selection. The individual should have a creative mindset and interest in developing strategies and directing innovative approaches to measure target modulation in (normal tissues) including genetic and pharmacological validation tools. Experience in leveraging and integrating gene expression and genomics data as well as cellular approaches to identify and advance programs is desired. A related expertise is demonstrable capability in innovative techniques emerging from organotypic, in vitro systems and genetic modification. Experience with gene manipulation editing (RNAi, CRISPR) or image analysis is a plus.

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Associate Director, Recombinant Proteins Group (8)

20 days ago
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Job Description: We are seeking a knowledgeable leader with substantial experience in running a protein production group. The candidate will be expected to lead a group of scientists to generate proteins (antigens and antibodies) using disparate modalities for therapeutic and reagent generation. Specific Responsibilities: • Establish a high functioning protein production core group. • Lead protein production group to generate antigens, antibodies, and cell-lines to facilitate discovery and project support. • Utilize and develop novel technologies/methodologies to express and purify antigens (in addition to multi-transmembrane containing proteins). • Guide scientists and team to address complex processes and transition leads into development. • Interface with multiple discovery project and matrix teams across the organization. • Excellent written and oral skills are necessary • Accomplish goals under project team time lines Requirements: • Ph.D. in Biochemistry, Structural/Molecular Biology, or related field with 6-8 years' experience or 10 years relevant experience. • Extensive experience in leading a core group of scientists to make high quality proteins for in vitro and in vivo testing. • Knowledge and experience in making antibodies from multiple species and technologies like bi-specifics, conjugation, and fusions is required. • Demonstrated ability to make complex antigens like multi-transmembrane receptors, oligomers, and difficult to express and purify proteins. • Demonstrated ability to generate proteins for crystallography and cryo-EM. • Hands-on experience with multiple expression systems/formats (mammalian, insect, yeast, and E. coli) and purification media (affinity, ion-exchange, hydrophobic, size-exclusion chromatography) and automation is required. • Experience in generating cell-lines (electroporation, viral transduction, etc.) is also required. • Experience in evaluating protein liabilities and formulations is highly desirable. • Excellent time management and organizational skills. • Demonstrated ability to work in a multidisciplinary biologics discovery team.

jobs byAdzuna

Associate Director Pharmacoepidemiology

20 days ago
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Wallingford Transition ASSOCIATE DIRECTOR-EPIDEMIOLOGY Job Summary: • Directly supervises the work in one therapeutic areas (TA), • Prioritizes activities across multiple projects in the assigned TA and effectively negotiates plans with colleagues and customers. • Communicates the role of pharmacoepidemiology within GPV&E and throughout BMS. • Ensures TA epidemiologists apply theoretical principles to real problems and bridge uncertainty of the real world with innovative pharmacoepidemiologic solutions. • Ensures TA team epidemiologists evaluate risk-benefit of pharmaceuticals in context of worldwide regulatory agency use of epidemiologic data. • Advises on pharmacoepidemiology principles to others in R&D. • Ensures that all tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness; and in accordance with current global regulatory requirements, good pharmacoepidemiology guidelines, and BMS cost effectiveness goals. Qualifications: • PhD in epidemiology or (MD, DO), MPH, at least 3-5 years' experience in the pharmaceutical industry, some management experience preferred

jobs byAdzuna

GCO Collaboration Lead for ONO

25 days ago
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Wallingford Transition Bristol - Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines

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Associate QC Scientist (Equipment Qualification, Lifecycle Management)

25 days ago
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Bristol - Myers Squibb is seeking top...you when it does. Bristol - Myers Squibb is a global biopharmaceutical company whose mission

jobs byJuju.com

Field Medical Scientist - UT, CO, NE, KS, NM, MO

25 days ago
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About Bristol - Myers Squibb : Bristol - Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver

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Research Associate Scientist

25 days ago
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Bristol - Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients

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Manager, Clinical Trial Registration and Results

25 days ago
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Bristol - Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients

jobs byJuju.com

Associate Research Scientist (Biology)

25 days ago
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…Cambridge, MA. There will be less than 10% travel. . Bristol - Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and

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Senior Scientist, Single B Cell Technology (36)

28 days ago
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We are looking for a highly motivated Senior Scientist to join the lead discovery effort within the biologics department in Redwood City, CA. This is an exciting opportunity to make a significant ...

jobs byZipRecruiter

Sales Operations Manager

about 1 month ago
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... and Bristol-Myers Squibb. Backed by Sequoia Capital, Zetta Venture Partners, Bloomberg Beta, and ... a company scales into hypergrowth * All about Data Science, there's no better place than at a ...

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Civil Engineering Intern

about 1 month ago
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... Bristol Engineering Services Company, LLC is seeking a Civil Engineer Intern in Anchorage, AK ... Education Two years of completed coursework in a Bachelor of Science in Civil Engineering program

jobs byZipRecruiter

Data Science Strategist

about 1 month ago
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... and Bristol-Myers Squibb. Backed by Sequoia Capital, Zetta Venture Partners, Bloomberg Beta, and ... Open office with access to company leaders and tools for remote employees to stay connected

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Group Fitness Instructor/Personal Trainer

11 months ago
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... company such as ACSM, ACE, NASM, NCSA, AFFA, NFPT (NCCA Certified) or degree in an exercise science ... Myers is set to open Summer/Early Fall 2018

jobs byZipRecruiter

Research Scientist

about 1 year ago
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Research Scientist Company Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious ...

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