Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience
Bristol Myers Squibb
12 days ago
Remote friendly (Madison, NJ)
United States
Medical Affairs
Position Responsibilities
General Product Support
- Oversee safety activities and benefit-risk strategies for assigned compound(s)/program(s); chair product/TA Safety Management Team (SMT).
- Review/approve aggregate safety documents (e.g., DSUR, PBRER) and safety sections of clinical/trial documents and regulatory filings.
- Lead signal evaluation/management across data sources; ensure documentation (e.g., Safety Topic Review/Signal Report).
- Approve safety labeling; provide safety subject matter expertise for regulatory labeling.
- Support qualified person activities (e.g., EU QPPV) and provide safety input to R&D publications/presentations.
Clinical Development
- Oversee global safety strategy; support submission document production and review final summary documents.
- Oversee medical safety development and benefit-risk management execution.
- Review safety input to study plans/protocols/amendments/IB/SAP/ICF/CSR and authority/IRB queries.
- Drive safety risk language and risk management strategy.
Postmarketing Support
- Oversee lifecycle safety strategy and global postmarketing safety submissions/studies.
- Approve DSUR/PBRER and support RMP execution; lead safety signal evaluation and regulatory responses.
- Ensure labeling reflects emerging postmarketing safety.
Department/Cross-functional/Leadership
- Drive process change, support inspections, manage issue/crisis response, liaise cross-functionally, hire/mentor staff.
- Identify data gaps, train employees, support due diligence/licensing input, act as TA liaison, support manufacturing quality and safety communications.
Qualifications/Requirements
- MD/equivalent required; postgraduate training/experience in internal medicine, immunology, oncology, or related desirable.
- 7+ years in pharmacovigilance (or relevant pharma/biomedical field) strongly preferred; management experience strongly preferred.
Key Competency Requirements
- Drug development lifecycle knowledge; PV expertise; regulatory safety assessment/action knowledge; analytical reasoning; attention to detail; ability to manage multiple complex projects; strong communication.
Travel
- Occasional US travel (e.g., every 2–3 months) and overseas travel (e.g., about once/year).
Compensation/Benefits (if applicable)
- $334,860–$405,769 base; additional incentive cash/stock may be available.
- Health coverage; wellbeing programs; 401(k), disability/life insurance, and other protections; paid time off (details vary by location/employment type).
General Product Support
- Oversee safety activities and benefit-risk strategies for assigned compound(s)/program(s); chair product/TA Safety Management Team (SMT).
- Review/approve aggregate safety documents (e.g., DSUR, PBRER) and safety sections of clinical/trial documents and regulatory filings.
- Lead signal evaluation/management across data sources; ensure documentation (e.g., Safety Topic Review/Signal Report).
- Approve safety labeling; provide safety subject matter expertise for regulatory labeling.
- Support qualified person activities (e.g., EU QPPV) and provide safety input to R&D publications/presentations.
Clinical Development
- Oversee global safety strategy; support submission document production and review final summary documents.
- Oversee medical safety development and benefit-risk management execution.
- Review safety input to study plans/protocols/amendments/IB/SAP/ICF/CSR and authority/IRB queries.
- Drive safety risk language and risk management strategy.
Postmarketing Support
- Oversee lifecycle safety strategy and global postmarketing safety submissions/studies.
- Approve DSUR/PBRER and support RMP execution; lead safety signal evaluation and regulatory responses.
- Ensure labeling reflects emerging postmarketing safety.
Department/Cross-functional/Leadership
- Drive process change, support inspections, manage issue/crisis response, liaise cross-functionally, hire/mentor staff.
- Identify data gaps, train employees, support due diligence/licensing input, act as TA liaison, support manufacturing quality and safety communications.
Qualifications/Requirements
- MD/equivalent required; postgraduate training/experience in internal medicine, immunology, oncology, or related desirable.
- 7+ years in pharmacovigilance (or relevant pharma/biomedical field) strongly preferred; management experience strongly preferred.
Key Competency Requirements
- Drug development lifecycle knowledge; PV expertise; regulatory safety assessment/action knowledge; analytical reasoning; attention to detail; ability to manage multiple complex projects; strong communication.
Travel
- Occasional US travel (e.g., every 2–3 months) and overseas travel (e.g., about once/year).
Compensation/Benefits (if applicable)
- $334,860–$405,769 base; additional incentive cash/stock may be available.
- Health coverage; wellbeing programs; 401(k), disability/life insurance, and other protections; paid time off (details vary by location/employment type).