The Senior Medical Director serves as the lead product safety physician for complex developmental programs, with a strong focus on early-phase clinical research and oncology preapproval safety. This role evaluates benefit-risk profiles, reviews safety data across trials and programs, and guides responses to emerging safety concerns, regulatory questions, and labeling changes. It also partners closely with clinical, medical affairs, regulatory, and safety teams to shape study documentation, monitoring plans, and postmarketing or development-stage safety strategy.
Key Responsibilities
- Oversee benefit-risk safety profiles for assigned products across the product life cycle, with primary focus on early development.
- Lead identification, assessment, escalation, and management of safety concerns for developmental and approved products.
- Chair safety governance meetings and represent safety perspectives in internal committees and cross-functional reviews.
- Review and advise on clinical trial documents, including protocols, investigator brochures, informed consent forms, and safety monitoring plans.
- Provide medical review of adverse events, serious adverse events, abnormal labs, and aggregate safety data.
- Lead safety input for regulatory responses, labeling updates, core safety information, and development safety reports.
- Collaborate with clinical development, medical affairs, regulatory, pharmacovigilance, and other global functions on safety strategy and communications.
- Train and mentor safety physicians and safety scientists, while supporting continuous process improvement.
Required
- MD or internationally recognized equivalent with accredited residency.
- At least 6 years of pharmaceutical or biotechnology industry experience in clinical research or clinical development.
- At least 4 years of safety experience in Phase 1 and Phase 2 development.
- Experience in pharmaceutical product development, including study design and filing plans.
- Experience with global regulatory requirements for pharmacovigilance.
- Experience interacting with regulatory agencies and key opinion leaders.
Preferred
- Accredited fellowship with 1 year of clinical experience in a relevant therapeutic area.
- Significant knowledge of general medicine.
- Experience in oncology preapproval development.
- Prior matrix management team experience.
- Prior experience as a product safety physician.