Global Safety Program Lead (GSPL), Cell Therapy, Immunology
Core
Senior Medical Director leading end-to-end safety strategy, benefit-risk assessment, and regulatory submissions for immunology cell therapy programs.
Role type
Senior Medical Director (Patient Safety Lead)
Builds
Safety strategies, regulatory submissions, and clinical development plans for cell therapy assets.
Domain
Biopharmaceuticals, Cell Therapy, Immunology
Required skills
Medical degree, clinical safety/pharmacovigilance, cell therapy development, immunology/rheumatology expertise, benefit-risk assessment, global pharmacovigilance regulations, matrix leadership, strategic influence
Preferred skills
Board certification, PhD, autologous/allogeneic/gene-edited therapy experience, multi-indication safety leadership, global market development experience
Technologies
Digital safety surveillance tools, data visualization, AI-enabled methods
Responsibilities
Own end-to-end safety strategy and delivery; lead safety strategy and surveillance teams; provide expert safety input to clinical development plans; identify and manage acute/delayed cell therapy risks; integrate evidence for benefit-risk decisions; represent safety at governance committees; ensure quality of regulatory submissions; line manage safety physicians and scientists.
Seniority
Senior, hands-on IC with leadership responsibilities