About this role
Job title: Global Safety Medical Director - Global Safety Officer, Oncology
About the Role The Global Safety Medical Director serves as the safety expert for the assigned product(s), establishing strategy, direction, and priorities for pharmacovigilance and owning the overall safety profile and product-related decisions. They lead the Safety Analysis Team (SAT) and Global Safety Team (GST), serve on the Executive Safety Committee (ESC), and participate in the Evidence Generation Team, with responsibility for Global Safety Physicians.
What You'll Do
- Provide safety strategy and governance for pharmacovigilance for the assigned product(s).
- Lead the Safety Analysis Team (SAT) and Global Safety Team (GST) and participate as a core member of the Executive Safety Committee (ESC); collaborate with cross-functional groups.
- Oversee clinical trial safety, safety data analysis, risk communication, and benefit-risk assessment for the product(s).
- Prepare and review safety information to support licensing partners and coordinate safety documents with licensing partners per safety agreements.
- Participate in safety agreement development and risk-management activities; ensure inspection readiness.
- Support regulatory filings including new drug applications and other submissions; contribute to commercialization readiness as needed.
- Manage and mentor Global Safety Physicians; delegate responsibilities for the Therapeutic Area Head as appropriate.
What We're Looking For
- MD or DO from an accredited medical school.
- Completion of an accredited medical or surgical residency, or clinical experience in an accredited academic or private practice setting (hospital-based).
- 2+ years of industry Global Safety experience (preferred).
- Oncology experience in early development (preferred).
- Product safety experience in the bio/pharmaceutical industry or with a regulatory agency (preferred).
- Previous management or mentoring experience (preferred).
- Experience with oncology products/early development (preferred).
Nice to Have
- Additional oncology or early development experience; leadership/mentoring skills (not already listed).
Compensation & Benefits
- The role offers an annual USD salary; the posted range is not specified here. Actual salary will vary by skills, experience, and qualifications.
- Total Rewards Plan includes: health and welfare benefits for employees and dependents, retirement savings plan with company contributions, stock-based long-term incentives, discretionary annual bonus, flexible time-off, and flexible work models where possible.