Associate Director, Patient Safety Scientist
Core
Lead safety science activities for cell therapy assets, integrating data to support benefit-risk decisions and manage patient risks across the product lifecycle.
Role type
Senior IC patient safety scientist (cell therapy)
Builds
Safety documentation, aggregate reports, risk-management plans, and regulatory submissions for cell therapy products
Domain
Biotechnology / Cell Therapy / Pharmacovigilance
Required skills
Safety surveillance and signal detection, MedDRA coding and search strategies, benefit-risk assessment, regulatory reporting (DSUR, PBRER, RMP), protocol and clinical study report safety sections, governance support, project management, scientific writing, AI workflow automation and validation
Preferred skills
Immunology or cell/gene therapy product development, pharmacoepidemiology, real-world evidence, quantitative safety methods, regulatory submission support, agentic AI configuration in regulated environments
Technologies
MedDRA, agentic AI tools, large language models, safety databases
Responsibilities
Conduct safety surveillance and signal detection; translate safety data into recommendations; lead pharmacovigilance planning; author aggregate safety reports; coordinate safety content for protocols and clinical reports; support regulatory submissions; present analyses to governance bodies; mentor junior scientists; apply AI tools to safety workflows; improve safety processes
Seniority
Senior, hands-on IC