Safety Director for Immunology Therapeutic Area

4 weeks ago


Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time
Job Summary

As a key member of the Bristol-Myers Squibb Company team, you will lead safety activities and benefit-risk strategies for assigned compounds/programs in the Immunology Therapeutic Area. This role involves chairing the product Safety Management Team(s) and overseeing the preparation and review of aggregate safety review documents, as well as safety sections of relevant clinical trial documents and regulatory filings.

Key Responsibilities
  • Lead team in the evaluation & management of signals emerging from any data source.
  • Develop strategy for signal evaluation and document outcome.
  • Lead safety labeling activities for assigned products/program.
  • Act as the Safety Subject Matter Expert for input to regulatory product labeling.
  • Lead process improvement projects.
  • Assist the Medical Safety Assessment (MSA) TA Head/Lead in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures within BMS Drug Development and WWPS.
  • Support the EU Qualified Person for PV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
  • Provide input to Drug Development publication strategy/plan & ensure safety input to publications/presentations.
  • Actively drive safety strategy preparation and represent WWPS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings.
Requirements
  • MD/equivalent required.
  • Postgraduate qualification or experience in internal medicine, immunology, or related specialty desirable.
  • 3+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred.
  • Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.

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 with the resources to pursue their goals, both at work and in their personal lives.



  • Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Job Title: Medical Safety Assessment Physician DirectorBristol-Myers Squibb Company is seeking a highly skilled Medical Safety Assessment Physician Director to join our team. As a key member of our Worldwide Patient Safety group, you will be responsible for ensuring the safety of our medicines.Key Responsibilities:Lead safety activities and benefit-risk...


  • Princeton, New Jersey, United States Clinical Resource Network (CRN) Full time

    Job Title: Medical Affairs Strategic Publication LeadDescription:The ideal candidate will have 10+ years of experience in publication planning in a pharmaceutical environment and a strong understanding of GPP3 and ICMJE. They will be responsible for supporting strategic planning and development of all publications within scope of therapeutic area focus,...


  • Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Job SummaryAs a Medical Safety Assessment Physician at Bristol-Myers Squibb Company, you will play a critical role in ensuring the safety of our medicines. You will lead safety activities and benefit-risk strategies for assigned BMS compounds/programs in the Immunology Therapeutic Area (TA) and chair the product Safety Management Team(s).Key...

  • Research Scientist

    4 weeks ago


    Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Work with UsAt Bristol Myers Squibb, we're committed to transforming patients' lives through science. Our team is dedicated to developing novel therapeutics for the treatment of multiple autoimmune and inflammatory diseases.Job SummaryWe're seeking a highly motivated individual to join our Discovery Immunology team located in Lawrenceville, NJ. The...


  • Princeton, New Jersey, United States ACADIA Pharmaceuticals Full time

    About Acadia PharmaceuticalsAcadia Pharmaceuticals is a leading biopharmaceutical company dedicated to advancing breakthroughs in neuroscience to elevate life. With over 30 years of experience, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. Our commitment to innovation and excellence has led to the...


  • Princeton, New Jersey, United States Strativ Group Full time

    Job Title: Director of Process Safety and Laboratory OperationsAbout the Role:We are seeking a highly experienced Director of Process Safety and Laboratory Operations to lead our Princeton site. As a key member of our team, you will be responsible for managing the daily operations of our laboratories, ensuring high-quality service delivery and optimal...


  • Princeton, New Jersey, United States Bristol Myers Squibb Full time

    Transforming Lives through ScienceBristol Myers Squibb is a leader in the pharmaceutical industry, and we're seeking a talented individual to join our Medical Evidence Generation (MEG) Clinical Research Collaborations (CRC) team. As the Director, Clinical Research Collaborations, you will play a critical role in bridging our company to the best external...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Regional Business Director of Field Reimbursement is a key leadership role at Sun Pharmaceutical Industries, Inc. This position is responsible for providing strategic direction and guidance to the Field Reimbursement team, ensuring maximum access to Sun's branded products across the branded business units.Key ResponsibilitiesLead the Field...


  • Princeton, New Jersey, United States Genmab Full time

    Genmab is seeking a seasoned Medical Education Leadership and Strategy Director to lead the development and execution of its independent medical education grants strategy and operations across therapeutic areas.The ideal candidate will serve as the lead for initial review of all corporate funding requests, ensuring close oversight and coordination of GMA...


  • Princeton, New Jersey, United States Otsuka Full time

    Job DescriptionReporting to the Executive Director of Business Development, the Director/Senior Director, Business Development will support global business development transactions.Key Responsibilities:Support global business development transactions, including product acquisitions and licensing deals, for the global market, including the US, with biotech...


  • Princeton, New Jersey, United States Genmab Full time

    Job SummaryWe are seeking a highly skilled and experienced Director of Medical Education and Corporate Funding to lead our Medical Education and Corporate Funding function. The successful candidate will be responsible for developing and executing the overall independent medical education grants strategy and operations across Genmab therapeutic areas.Key...


  • Princeton, New Jersey, United States Otsuka Full time

    Job SummaryReporting to the Executive Director of Business Development, the Director/Senior Director, Business Development will support global business development transactions. The role requires extensive experience in the pharmaceutical industry, along with a strong scientific and development background, proven project and people leadership, business and...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Regional Business Director of Field Reimbursement is a key leadership role within Sun Pharmaceutical Industries, Inc. This position is responsible for providing strategic direction and guidance to the Field Reimbursement team, ensuring the successful execution of access and coverage strategies for Sun's branded products across the US...


  • Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Transforming Patients' Lives through ScienceAt Bristol Myers Squibb Company, we are committed to transforming patients' lives through science. As a Director of Biostatistics, you will play a critical role in this mission by leading the development of innovative and efficient clinical trials. Your expertise in statistical analysis and data interpretation will...


  • Princeton, New Jersey, United States Genmab AS Full time

    Job Title: Director, Legal CounselGenmab is seeking a highly skilled and experienced Director, Legal Counsel to join our US Market Operations team in Princeton, NJ.About the RoleThe Director, Legal Counsel will provide legal support to our US Market Operations organization, assisting in the review, drafting, and negotiation of agreements. This role will also...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    The Senior Director, Global Regulatory Portfolio Lead, will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas. This role will be a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, GRA. The successful candidate will serve as a key corporate...

  • Maintenance Director

    1 month ago


    Princeton, New Jersey, United States VP Management Full time

    Job OverviewWe are seeking a highly skilled and experienced Maintenance Director to join our team at VP Management.The successful candidate will be responsible for ensuring the maintenance of our hotel building and contributing to a better hotel environment.Key ResponsibilitiesInspect and maintain all emergency tools to ensure they are in good working...


  • Princeton, New Jersey, United States Amicus Therapeutics Full time

    Job SummaryThe Executive Director, Program Management leads the Program Alignment Subteams and manages cross-functional resource and alignment across ongoing development, post-marketing commitments, and evidence generation workstreams. This role requires strategic leadership, planning, and risk management to drive program goals and ensure seamless handoffs...


  • Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job DescriptionRegional Business Director of Field ReimbursementThe Regional Business Director of Field Reimbursement is a critical leadership role that supports the market access strategy for Sun Pharmaceutical Industries, Inc.'s branded products across various business units. This position provides strategic leadership related to health policy,...


  • Princeton, New Jersey, United States Amicus Therapeutics Full time

    Program Management Director, Executive RoleThe Program Management Director, Executive Role leads the Program Alignment Subteams and manages cross-functional resource and alignment across ongoing development, post-marketing commitments, and evidence generation workstreams. This role ensures seamless handoff to the Brand Leadership Team for successful...