Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience
Bristol Myers Squibb
3 days ago
Remote friendly (Lawrence, NJ)
United States
Medical Affairs
Position Summary:
- Provide strategic oversight and delivery of medical safety assessment for assets in a therapeutic area by managing the safety physician team.
- Oversee safety activities and benefit-risk strategies for assigned compounds/programs; chair 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 evaluation/management of safety signals from any data source; guide signal evaluation strategy and ensure documentation.
- Approve safety labeling activities and provide safety subject matter expertise for regulatory labeling.
- Drive adoption of new PV processes and assist the MSA TA Head with state-of-the-art PV processes.
Position Responsibilities:
General Product Support; Clinical Development; Postmarketing Support; Department & Cross-functional Activities; Leadership behaviors (communicate strategy, coach, motivate/retain, performance feedback, resolve conflict).
Degree/Experience Requirements:
- MD/equivalent required.
- Postgraduate qualification/experience in internal medicine, immunology, oncology, or related specialty desirable.
- 7+ years in pharmacovigilance (PV) or relevant pharma/biomedical field strongly preferred; management experience strongly preferred.
Key Competency Requirements (high level):
- Drug development process expertise; PV expertise to assess safety risk across lifecycle.
- Regulatory safety assessment/action knowledge.
- Analytical reasoning; ability to manage multiple complex projects; strong attention to detail.
- Strong verbal/written communication; ability to lead in a matrix environment.
Travel: Occasional US (about every 2–3 months) and overseas (about once/year).
Compensation/Benefits (as stated):
- $334,860–$405,769; additional incentive cash/stock may be available.
- Health coverage; wellbeing support; 401(k), disability, life/accident insurance, and other listed protections.
- Paid time off: flexible time off (US exempt) or annual paid vacation for certain roles; plus other time-off options based on eligibility.
- Provide strategic oversight and delivery of medical safety assessment for assets in a therapeutic area by managing the safety physician team.
- Oversee safety activities and benefit-risk strategies for assigned compounds/programs; chair 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 evaluation/management of safety signals from any data source; guide signal evaluation strategy and ensure documentation.
- Approve safety labeling activities and provide safety subject matter expertise for regulatory labeling.
- Drive adoption of new PV processes and assist the MSA TA Head with state-of-the-art PV processes.
Position Responsibilities:
General Product Support; Clinical Development; Postmarketing Support; Department & Cross-functional Activities; Leadership behaviors (communicate strategy, coach, motivate/retain, performance feedback, resolve conflict).
Degree/Experience Requirements:
- MD/equivalent required.
- Postgraduate qualification/experience in internal medicine, immunology, oncology, or related specialty desirable.
- 7+ years in pharmacovigilance (PV) or relevant pharma/biomedical field strongly preferred; management experience strongly preferred.
Key Competency Requirements (high level):
- Drug development process expertise; PV expertise to assess safety risk across lifecycle.
- Regulatory safety assessment/action knowledge.
- Analytical reasoning; ability to manage multiple complex projects; strong attention to detail.
- Strong verbal/written communication; ability to lead in a matrix environment.
Travel: Occasional US (about every 2–3 months) and overseas (about once/year).
Compensation/Benefits (as stated):
- $334,860–$405,769; additional incentive cash/stock may be available.
- Health coverage; wellbeing support; 401(k), disability, life/accident insurance, and other listed protections.
- Paid time off: flexible time off (US exempt) or annual paid vacation for certain roles; plus other time-off options based on eligibility.