Global Safety Program Lead (GSPL), Cell Therapy, Immunology

Start free →

Or apply yourself on the official page →

About the role

Do you bring expertise in patient safety, clinical development, and cell therapy, together with a passion for improving outcomes in immune-mediated and autoimmune diseases? This is an opportunity to provide medico-scientific and strategic safety leadership for innovative cell therapy programs across development and, where applicable, postmarketing. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. Within Global Patient Safety, you will shape safety strategy for high-impact cell therapy assets, lead cross-functional teams, optimize benefit-risk, and enable evidence-based development decisions. You will work across a growing immunology cell therapy portfolio that may span multiple autoimmune indications, stages of development, and therapeutic modalities. In-person collaboration helps us connect, work at pace, and challenge established thinking. We therefore work, on average, a minimum of three days per week from the office, while respecting individual flexibility in line with local policy. The role As Senior Medical Director, Global Safety Program Lead, Cell Therapy - Immunology, you will report to the Global Safety Head of the Cell Therapy Patient Safety Unit. You will serve as the senior Patient Safety leader for assigned immunology cell therapy programs and bring deep clinical judgement to benefit-risk assessment, program design, regulatory strategy, and governance. You will shape safety strategy from early development through late-stage development and, where applicable, postmarketing; lead and develop safety physicians and scientists; and help build a proactive, accountable, and science-led culture within the unit. Accountabilities · Own the end-to-end safety strategy, delivery, and oversight for assigned immunology cell therapy asset(s) and indications across preclinical, clinical, regulatory, and postmarketing stages, as applicable. · Lead the Safety Strategy and Management Team and Safety Surveillance Team for assigned asset(s), setting clear safety objectives aligned with therapeutic-area and product strategy and ensuring high-quality, timely, and compliant delivery. · Own the scientific and clinical safety content for assigned programs, including the safety Target Product Profile, safety Go/No-Go criteria, toxicity management guidelines, risk minimization approaches, and internal and external safety messaging. · Provide expert safety input to clinical development plans, study concepts and protocols, dose-escalation and expansion decisions, eligibility criteria, monitoring plans, stopping rules, long-term follow-up, and interpretation of emerging data. · Lead proactive identification, evaluation, and management of acute and delayed cell therapy risks, including immune-mediated toxicities, infections, cytopenias, neurotoxicity, secondary malignancies, and risks associated with lymphodepletion or prolonged immune modulation, as relevant to the program. · Integrate clinical, translational, biomarker, epidemiology, preclinical, real-world, and literature evidence to support benefit-risk decisions across multiple autoimmune indications and patient populations. · Represent Global Patient Safety at product teams, governance committees, health-authority interactions, independent data-monitoring committees, advisory boards, and other internal or external forums; ensure clear alignment of the Patient Safety position before key decisions. · Ensure the quality and timely delivery of safety contributions to Investigator Brochures, protocols, informed consent documents, clinical study reports, DSURs, RMPs, periodic safety reports, regulatory submissions, responses to health authorities and ethics committees, and product labeling, as applicable. · Provide strategic leadership to safety physicians and scien

View the official posting →