Director, Senior Patient Safety Scientist
Core
Senior scientific leader leading safety science strategy and delivery for complex cell therapy assets, integrating clinical and real-world evidence to shape safety profiles and guide benefit-risk decisions.
Role type
Director, Cell Therapy Patient Safety Scientist
Builds
Safety profiles, risk management plans, regulatory submissions (NDA/BLA/MAA), 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 communication, Team leadership, Pharmacovigilance regulations knowledge, Data analysis, Protocol development, Third-party agreement safety provisions
Preferred skills
Cell therapy safety expertise, Immunology background, Pharmacoepidemiology, Real-world evidence analysis, Regulatory inspection leadership, GxP AI deployment, International regulatory knowledge (China/Japan/Australia)
Technologies
Large language models, Agentic AI tools, MedDRA, DSUR/PBRER/RMP systems
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; Provide strategic oversight for aggregate safety reports; Lead safety content for clinical protocols and study reports; Represent Patient Safety in regulatory submissions and inspections; Chair safety forums and cross-functional discussions; Mentor safety scientists and build function capability; Sponsor process improvements for safety analytics; Define and oversee responsible use of agentic AI in safety workflows.
Seniority
Director, Strategic Leadership & Mentorship