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, periodic reports, risk management plans, and regulatory submissions for cell therapy products
Domain
Biotechnology / Cell Therapy / Pharmacovigilance
Required skills
Pharmacovigilance, signal detection, benefit-risk assessment, MedDRA coding, regulatory submissions, project management, scientific writing, AI workflow automation
Preferred skills
Immunology, cell and gene therapy development, pharmacoepidemiology, real-world evidence, quantitative safety methods, agentic AI configuration
Technologies
MedDRA, LLMs, agentic AI tools, 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 clinical protocols and submissions; support regulatory interactions; coach junior scientists; apply AI tools to safety workflows.
Seniority
Senior, hands-on IC with mentorship
