Head of Exploratory and Regulatory Safety Sciences

Key Duties & Responsibilities Provide nonclinical regulatory strategy leadership, oversight, and advice for Vertex preclinical safety and risk management across discovery to registration and loss of exclusivity. Advance regulatory acceptance of innovative scientific approaches; promote regulatory packages to accelerate portfolio deliverables. Serve as subject matter expert in nonclinical and late-stage development/registration for small molecules, biologics, cell therapies, and other novel modalities. Lead matrix activities across the preclinical safety assessment (PSA) organization; ensure regulatory responsibilities comply with applicable standards. Contribute to issues management plans; participate in regulatory submission documents, posters, publications, and responses to global health authority queries. Resolve toxicological issues and assess relevance to human safety. Act as a Toxicology Disease Area Lead (TDAL); participate in PSA leadership/extended team. Develop next-generation PSA ERSS leaders; manage ERSS resource allocation and external influencing; lead external engagement (e.g., consortia). Required Education & Experience Ph.D. and/or DVM (or equivalent) 15+ years preclinical safety R&D in pharma/biotech Expertise in preclinical development and deep understanding of FDA/EMA/ICH guidance and international GLP Required Skills Strong analytical/problem-solving; lead troubleshooting in preclinical development Excellent communicator/influencer; strong writing and persuasion Ability to make high-quality decisions in ambiguity Proven success partnering/influencing senior leaders; experience in highly matrixed organizations Pay Range $280,000 - $420,000 #J-18808-Ljbffr Scorpion Therapeutics