Director, Medical Safety and Risk Management

Role: Director of Medical Safety and Risk Management overseeing the safety profile of assigned biopharma products throughout their lifecycle. Responsibilities: lead safety strategy, monitor and assess safety data via signal detection, guide clinical teams on safety aspects, ensure timely safety deliverables for regulatory submissions, lead multidisciplinary safety teams, provide strategic safety insights to stakeholders, author safety documents (e.g., DSUR, RMPs, PSUR), and collaborate with pharmacovigilance partners. Requirements: Medical Degree with at least 3 years of medical practice; industry experience in pharmacovigilance or clinical development preferred; strong clinical acumen, therapeutic area knowledge, and regulatory familiarity (FDA, EU, ICH). HighValue: focus on drug safety for biologics, gene therapies, or small molecules, across all development phases, with a strong emphasis on safety data analysis, regulatory compliance, and external stakeholder communication. WorkSetup: not specified; likely office-based with potential for cross-functional collaboration.