Director, Senior Patient Safety Scientist
Core
Senior scientific leader driving safety science strategy, signal detection, and benefit-risk decisions for complex cell therapy assets across the product lifecycle.
Role type
Director, Senior Patient Safety Scientist (Cell Therapy)
Builds
Safety profiles, risk management plans, regulatory submissions, and governance reports for cell therapy products.
Domain
Biotechnology / Cell Therapy / Pharmacovigilance
Deliverable
production ML models
Required skills
Safety surveillance and signal detection, Benefit-risk assessment, Regulatory strategy (US/EU/UK), Agentic AI workflow design, Scientific writing, Cross-functional leadership, MedDRA search strategy, Risk management planning
Preferred skills
Cell therapy safety expertise, Pharmacoepidemiology, Real-world evidence analysis, Regulatory inspection leadership, Advanced degree in immunology/pharmacology
Technologies
Large language models, Agentic AI tools, MedDRA
Responsibilities
Lead safety surveillance and signal detection for cell therapy assets; Set safety science strategy for complex assets; Lead proactive pharmacovigilance and risk management planning; Chair safety forums and cross-functional discussions; Mentor safety scientists and build functional capability; Define and oversee responsible use of agentic AI in safety workflows.
Seniority
Director, Strategic Leadership & Mentorship
