Director, Medical Safety Assessment Physician
Bristol Myers Squibb
August 23, 2026
Remote friendly (Princeton, NJ)
United States
Medical Affairs
Responsibilities:
- Lead safety activities and benefit-risk strategies for assigned compounds/programs; chair Product Safety Management Team(s).
- Oversee/prepare/review aggregate safety documents (e.g., DSUR, PBRER) and safety sections of clinical trial documents and regulatory filings.
- Lead signal evaluation/management; develop signal evaluation strategy and document outcomes.
- Lead safety labeling as Safety Subject Matter Expert; support cross-functional labeling meetings and regional labeling.
- Support PV Qualified Person (EU QPPV or other regional/local) for assigned products.
- Drive process improvement; develop/maintain state-of-the-art PV processes; support inspections and issue/crisis management.
- Act as global safety lead in clinical development; provide safety input across development documents and submissions.
- Lead postmarketing safety oversight: risk management/RMP elements, safety signal work, postmarketing submissions, and safety study guidance.
Qualifications:
- MD/equivalent required; postgraduate training or experience in internal medicine, immunology, oncology (desirable).
- 3+ years in PV or relevant pharma/biomedical field (strongly preferred).
Skills/Abilities:
- Drug development and PV knowledge; ability to apply tools (incl. observational research) to safety concerns.
- Understanding of regulatory safety requirements; strong analytical reasoning, attention to detail.
- Able to manage multiple projects; strong verbal/written communication.
Travel: Occasional US and overseas travel.
Benefits (explicit): Health/dental/vision; wellbeing support; 401(k) and insurance/disability; PTO (flexible time off for US exempt or 160 hours vacation for some roles) and Global Shutdown.
Application instruction: If the role doesn’t perfectly match your resume, encouraged to apply anyway.
- Lead safety activities and benefit-risk strategies for assigned compounds/programs; chair Product Safety Management Team(s).
- Oversee/prepare/review aggregate safety documents (e.g., DSUR, PBRER) and safety sections of clinical trial documents and regulatory filings.
- Lead signal evaluation/management; develop signal evaluation strategy and document outcomes.
- Lead safety labeling as Safety Subject Matter Expert; support cross-functional labeling meetings and regional labeling.
- Support PV Qualified Person (EU QPPV or other regional/local) for assigned products.
- Drive process improvement; develop/maintain state-of-the-art PV processes; support inspections and issue/crisis management.
- Act as global safety lead in clinical development; provide safety input across development documents and submissions.
- Lead postmarketing safety oversight: risk management/RMP elements, safety signal work, postmarketing submissions, and safety study guidance.
Qualifications:
- MD/equivalent required; postgraduate training or experience in internal medicine, immunology, oncology (desirable).
- 3+ years in PV or relevant pharma/biomedical field (strongly preferred).
Skills/Abilities:
- Drug development and PV knowledge; ability to apply tools (incl. observational research) to safety concerns.
- Understanding of regulatory safety requirements; strong analytical reasoning, attention to detail.
- Able to manage multiple projects; strong verbal/written communication.
Travel: Occasional US and overseas travel.
Benefits (explicit): Health/dental/vision; wellbeing support; 401(k) and insurance/disability; PTO (flexible time off for US exempt or 160 hours vacation for some roles) and Global Shutdown.
Application instruction: If the role doesn’t perfectly match your resume, encouraged to apply anyway.