Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience
Bristol Myers Squibb
August 13, 2026
Remote friendly (Princeton, NJ)
United States
Medical Affairs
Position Responsibilities
- Provide strategic oversight and delivery of medical safety assessment for assets in the therapeutic area (TA) by managing the safety physician team.
- Oversee safety activities and benefit-risk strategies for assigned compounds/programs; chair the product/TA Safety Management Team (SMT).
- Oversee/review/approve aggregate safety review documents (e.g., DSUR, PBRER), safety sections of clinical trial documents (protocols, CSRs, IBs, ICFs), and regulatory filings (CTA, MAA).
- Lead evaluation and management of safety signals from any data source; guide signal evaluation strategy and ensure documentation.
- Approve safety labeling activities; provide safety subject matter expertise for regulatory labeling.
- Oversee global safety strategy in development and postmarketing lifecycle safety; drive safety risk language/RMP elements; ensure medical safety reviews of DSUR/annual reports.
- Support regulatory meetings and inspections; assist issue/crisis management; liaise across TA functions; hire/develop staff.
Qualifications / Requirements
- MD/equivalent required.
- Postgraduate qualification/experience in internal medicine, immunology, oncology (desirable).
- 7+ years in pharmacovigilance (strongly preferred); management experience strongly preferred.
Key Competencies
- Deep drug development and PV knowledge; regulatory safety requirements; analytical reasoning; manage multiple complex projects; excellent communication and attention to detail.
Travel: Occasional US and overseas travel.
Compensation/Benefits (as listed): $334,860–$405,769; health coverage; wellbeing support; 401(k), disability, life/insurance; Paid Time Off (details vary by eligibility).
- Provide strategic oversight and delivery of medical safety assessment for assets in the therapeutic area (TA) by managing the safety physician team.
- Oversee safety activities and benefit-risk strategies for assigned compounds/programs; chair the product/TA Safety Management Team (SMT).
- Oversee/review/approve aggregate safety review documents (e.g., DSUR, PBRER), safety sections of clinical trial documents (protocols, CSRs, IBs, ICFs), and regulatory filings (CTA, MAA).
- Lead evaluation and management of safety signals from any data source; guide signal evaluation strategy and ensure documentation.
- Approve safety labeling activities; provide safety subject matter expertise for regulatory labeling.
- Oversee global safety strategy in development and postmarketing lifecycle safety; drive safety risk language/RMP elements; ensure medical safety reviews of DSUR/annual reports.
- Support regulatory meetings and inspections; assist issue/crisis management; liaise across TA functions; hire/develop staff.
Qualifications / Requirements
- MD/equivalent required.
- Postgraduate qualification/experience in internal medicine, immunology, oncology (desirable).
- 7+ years in pharmacovigilance (strongly preferred); management experience strongly preferred.
Key Competencies
- Deep drug development and PV knowledge; regulatory safety requirements; analytical reasoning; manage multiple complex projects; excellent communication and attention to detail.
Travel: Occasional US and overseas travel.
Compensation/Benefits (as listed): $334,860–$405,769; health coverage; wellbeing support; 401(k), disability, life/insurance; Paid Time Off (details vary by eligibility).