Senior Director, Safety Physician
Core
Provide medical and scientific leadership for the evaluation of safety profiles and benefit-risk of investigational and commercial products across the product lifecycle.
Role type
Senior Director, Safety Physician (Medical Safety Lead)
Builds
Safety assessments, regulatory submissions, risk management plans, and periodic safety reports for clinical-stage and commercial products.
Domain
Biotechnology / Pharmacovigilance / Drug Safety
Required skills
Medical degree (MD/DO), Board certification, 10+ years in medicine/pharma/biotech, Safety Physician experience, Global PV regulations expertise, Clinical trial data interpretation, Regulatory submission experience, Cross-functional collaboration, Strategic thinking, Hands-on execution
Preferred skills
Late-stage development experience, Product launch experience, Risk minimization activities experience, Partnership/licensing safety expertise
Technologies
DSURs, PBRERs/PSURs, REMS, Investigator Brochures, Clinical Study Reports, Integrated Safety Summaries
Responsibilities
Lead safety signal detection, validation, and assessment; Review and medically assess serious adverse events and safety trends; Provide medical oversight for case assessment and follow-up; Partner on protocol development and safety monitoring strategies; Contribute to regulatory submissions and health authority interactions; Present safety assessments to governance committees; Collaborate on risk management plans and labeling.
Seniority
Senior Director, strategic leadership with hands-on execution
