Global Safety Program Lead - Cell Therapy Oncology & Onco-Hematology
Core
Senior leader responsible for end-to-end safety strategy, delivery, and oversight of cell therapy oncology assets (specifically AZD0120 Multiple Myeloma) across pre-clinical, clinical, and post-marketing phases.
Role type
Senior IC Global Safety Program Lead (Cell Therapy Oncology)
Builds
Safety strategies, regulatory submissions, risk minimization plans, and safety messaging for novel Cell and Gene Therapy (CGT) products.
Domain
Biopharmaceuticals, Oncology, Onco-Hematology, Cell and Gene Therapy (CGT)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical safety/pharmacovigilance expertise, benefit-risk assessment, global PV regulations knowledge, matrix leadership, cross-functional influence, signal management, regulatory submission experience, team management
Preferred skills
PhD in relevant scientific discipline, oncology/haemato-oncology medical specialty, translational research background, industry conference speaking experience, in-licensing/due diligence safety perspective
Technologies
Digital/AI tools for adverse event visualization and disproportionality analysis
Responsibilities
Lead Safety Strategy & Management Team and Safety Surveillance Team; Own scientific and clinical safety content (TPP, Go/No-Go criteria, toxicity guidelines); Represent Global Patient Safety at governance forums; Ensure quality and compliance of safety documents (RMPs, PSURs/PSRs); Provide strategic safety leadership to medical directors and scientists; Line manage and develop a team of safety physicians/scientists
Seniority
Senior, hands-on IC with mentorship responsibilities
