Director, Drug Safety

Role: Lead drug safety and pharmacovigilance strategy for early and late-stage development programs in biopharma, focusing on high unmet medical needs such as metastatic breast cancer and ALS. Responsibilities: develop safety infrastructure, oversee signal detection, risk management, aggregate reporting (DSURs, PBRERs), and support regulatory interactions including safety dossier development. Serve as the safety lead for health authority engagements, translate safety data into clear guidance, and support clinical and commercial planning. Build safety processes and SOPs within a lean organization; no direct reports at hire, with future growth potential. Requirements: 8+ years in biopharma drug safety/pharmacovigilance, preferably with oncology/neurology expertise; experience in late-stage development and regulatory submissions; strong knowledge of global pharmacovigilance regulations, safety databases, and safety data analysis tools. Education: degree in life sciences or related field; certifications preferred. HighValue: early/late-stage therapeutics development, small molecules, neurodegenerative or oncology indications, regulatory submissions, global safety compliance, cross-functional stakeholder engagement. WorkSetup: not specified.