Global Safety Program Lead - Cell Therapy Oncology & Onco-Hematology

Opportunity:
Global Safety Program Lead
- Cell Therapy Oncology & Onco-Hematology

Location:

Barcelona, Spain (on-site) 3 days working from the office and 2 days working from home.

Do you have expertise in, and passion for Patient Safety in Oncology and Onco-Hematology? Would you like to apply your expertise to provide medico-scientific and clinical strategic leadership in a company that follows the science and turns ideas into innovative life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, science‑led, patient‑focused biopharmaceutical company. Within Global Patient Safety, you will shape the safety strategy of high‑impact assets and lead cross‑functional teams to optimize benefit‑risk and maintain competitive advantage across development and post‑marketing. Working with one of the broadest cell therapy pipelines in the industry offers the possibility to advance the most novel Cell and Gene Therapy (CGT) technologies at all development stages across multiple indications.

As a Global Safety Program Lead
- Cell Therapy Oncology & Onco‑Hematology, you will report to the Global Safety Head (GSH) of the Cell therapy Patient Safety Unit (CTPSU). You will be a senior leader within the CTPSU and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca cell therapies in oncology, specifically, but not limited to, the AZD
0120 DURGA program in Multiple Myeloma. You will also have a role in shaping the culture of the department and will act as a coach and mentor to more junior Patient Safety staff. You will ensure processes adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements as well as AZ processes.

• Lead the Safety Strategy & Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s), setting safety goals aligned to therapeutic area and product strategy, and ensuring high‑quality, compliant delivery of safety activities.
• Own the scientific and clinical safety content for the asset(s), including safety TPP, safety Go/No‑Go criteria, toxicity management guidelines, and safety messaging, integrating inputs from clinical, epidemiology, pre‑clinical, and literature.
• Represent Global Patient Safety at key governance and external forums (e.g., DRC, eCRC, SARB, FSIRB, DSMB/DMC, MARC, CPT, GPT, Advisory Boards) in partnership with the Global Safety Head; lead responses to complex technical safety issues.
• Ensure the quality, compliance, and timely delivery of safety documents (e.g., RMPs, PSURs/PSRs) and safety contributions to study design, protocol concepts, regulatory submissions, HA/EC queries, and labeling for global markets.
• Provide strategic safety leadership to safety medical directors and scientists, guiding study and program execution, data monitoring and interpretation, signal management, and post‑marketing surveillance to inform labeling and risk minimization.
• Build and maintain strong internal and external networks, including alliance partners, to drive proactive, cross‑functional, solution‑oriented safety actions; may support due diligence and in‑licensing assessments.
• Ensuring expert input to safety‑relevant elements of study design and interpretation, including efficient use of digital/ artificial intelligence (AI) tools and methodology (e.g. adverse event visualisation and disproportionality analysis).
• Line manage and develop a team of safety physicians and/or scientists; embed new processes, systems, and ways of working; prioritize risk mitigation and effective issue resolution; operate to the highest ethical, quality, GxP, and AZ standards.

• Medical degree or equivalent degree in biomedicine or science, with extensive clinical safety/pharmacovigilance experience.
• Strong relevant experience in clinical safety and risk management across pharma/biotech/CRO/academia/Health Authorities, spanning pre‑ and post‑launch.
• Proven track record of leading asset safety strategy and delivery, with demonstrated strategic influence on clinical studies/programs and benefit‑risk decisions.
• Deep knowledge of global PV regulations, standards, and safety…