Global Safety Program Lead - Cell Therapy Oncology & Onco-Hematology
AstraZeneca
September 05, 2026
Full-time
Remote friendly (Gaithersburg, MD)
Worldwide
Clinical Research and Development
Role: Lead global safety strategy for AstraZeneca's Cell Therapy Oncology and Onco-Hematology assets, focusing on benefitβrisk assessment and post-marketing safety. Responsibilities: oversee safety management teams, develop safety plans including TPP and risk minimization strategies, represent safety in governance forums, ensure regulatory compliance of safety documents, provide strategic guidance to safety teams, and foster cross-functional collaborations; mentor junior safety staff. Requirements: medical degree or equivalent in biomedicine/science; extensive clinical safety/pharmacovigilance experience across pre-and post-approval phases; proven leadership in asset safety strategy; deep knowledge of PV regulations and safety deliverables; strong matrix leadership and communication skills; experience with gene and cell therapies; willingness to travel domestically and internationally. Preferred: advanced degrees (PhD), oncology/haematology expertise, translational research background, experience with PV regulations in key Asian markets, industry conference speaking, and in-licensing support. High-Value: cell and gene therapy, oncology/haematology indications, late-stage development and post-market phases, regulatory interactions, and safety leadership in biotech/pharma settings. Work Setup: on-site in Gaithersburg, US, with a hybrid work model (3 days in-office, 2 days remote).