Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience
Bristol Myers Squibb
13 hours ago
Remote friendly (Princeton, NJ)
United States
Medical Affairs
Position Summary
- Provide strategic oversight and delivery of medical safety assessment for assets in a therapeutic area by effectively managing a safety physician team.
- Oversee safety activities and benefit-risk strategies for assigned compounds/programs; chair the product/TA Safety Management Team (SMT).
- Oversee, review, and approve aggregate safety review documents and safety sections of clinical trial documents and regulatory filings.
- Oversee signal evaluation/management from any data source; guide signal evaluation strategy and ensure required documentation.
- Approve safety labeling activities; provide safety subject matter expertise for regulatory labeling.
- Drive process change and maintain state-of-the-art PV processes.
Responsibilities (high level)
- Global safety strategy in development; oversee safety risk language, risk management strategy, and pre-filing safety activities.
- Ensure review of DSURs, annual reports, and periodic safety submissions; represent WWPS at health authority meetings.
- Lifecycle/postmarketing safety oversight, submissions, risk management plan (RMP) elements, and safety signal reporting.
- Support regulatory inspections; issue/crisis management; patient safety team collaboration; hire/mentor staff.
Qualifications/Required Skills
- MD/equivalent required.
- 7+ years in pharmacovigilance or relevant pharmaceutical/biomedical field strongly preferred; management experience strongly preferred.
- Extensive drug development understanding; expert PV and regulatory safety requirements; strong scientific/analytical reasoning; attention to detail; ability to manage multiple complex projects; excellent written/verbal communication.
Travel
- Occasional US travel (about once every 2–3 months) and overseas travel (about once a year).
Compensation/Benefits (explicit)
- $334,860 – $405,769.
- Health coverage; wellbeing programs; 401(k) and other financial protection benefits; paid time off (flexible time off/annual vacation and holidays; eligibility varies by location).
Application instructions
- If the role doesn’t perfectly match your resume, they encourage you to apply anyway.
- Provide strategic oversight and delivery of medical safety assessment for assets in a therapeutic area by effectively managing a safety physician team.
- Oversee safety activities and benefit-risk strategies for assigned compounds/programs; chair the product/TA Safety Management Team (SMT).
- Oversee, review, and approve aggregate safety review documents and safety sections of clinical trial documents and regulatory filings.
- Oversee signal evaluation/management from any data source; guide signal evaluation strategy and ensure required documentation.
- Approve safety labeling activities; provide safety subject matter expertise for regulatory labeling.
- Drive process change and maintain state-of-the-art PV processes.
Responsibilities (high level)
- Global safety strategy in development; oversee safety risk language, risk management strategy, and pre-filing safety activities.
- Ensure review of DSURs, annual reports, and periodic safety submissions; represent WWPS at health authority meetings.
- Lifecycle/postmarketing safety oversight, submissions, risk management plan (RMP) elements, and safety signal reporting.
- Support regulatory inspections; issue/crisis management; patient safety team collaboration; hire/mentor staff.
Qualifications/Required Skills
- MD/equivalent required.
- 7+ years in pharmacovigilance or relevant pharmaceutical/biomedical field strongly preferred; management experience strongly preferred.
- Extensive drug development understanding; expert PV and regulatory safety requirements; strong scientific/analytical reasoning; attention to detail; ability to manage multiple complex projects; excellent written/verbal communication.
Travel
- Occasional US travel (about once every 2–3 months) and overseas travel (about once a year).
Compensation/Benefits (explicit)
- $334,860 – $405,769.
- Health coverage; wellbeing programs; 401(k) and other financial protection benefits; paid time off (flexible time off/annual vacation and holidays; eligibility varies by location).
Application instructions
- If the role doesn’t perfectly match your resume, they encourage you to apply anyway.