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 haveexpertisein, and passion for Patient Safety in Oncologyand Onco-Hematology? Would you like to apply yourexpertiseto 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 tooptimizebenefit–risk andmaintaincompetitive advantage across development andpost‑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.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work atpaceand challenge perceptions.That’swhy we work, on average, a minimum of three days per week from the office. But thatdoesn’tmeanwe’renot flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
As a Global Safety Program Lead - Cell Therapy Oncology & Onco-Hematology, you will report to theGlobal 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 AZD0120 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.
Accountabilities
In this role, you are accountable to the Global Safety Head, Cell Therapy,for theend‑to‑endsafety strategy, delivery, and oversight ofAZD0120 Multiple Myelomaprogram, and potentially otherassets,acrosspre‑clinical, clinical, andpost‑marketing. You will:
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 ensuringhigh‑quality, compliant delivery of safety activities.
Own the scientific and clinical safety content for the asset(s), including safety TPP, safety Go/No‑Gocriteria, 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, andtimelydelivery 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, andpost‑marketingsurveillance to inform labeling and risk minimization.
Build andmaintainstrong internal and external networks, including alliance partners, to drive proactive,cross‑functional,solution‑orientedsafety actions; may support due diligence andin‑licensingassessments.
Ensuring expert input to safety-relevant elements of study design and interpretation, including efficient use of digital/ artificial intelligence (AI) tools andmethodology(e.g.adverse eventvisualisationand disproportionality analysis).
Linemanageanddevelopa team of safety physicians and/or scientists;embednew processes, systems, and ways of working; prioritize risk mitigation and effective issue resolution;operateto the highest ethical, quality,GxP, and AZ standards.
Essential for the role
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‑andpost‑launch.
Proventrack recordof leading asset safety strategy and delivery, withdemonstratedstrategic influence on clinical studies/programs and benefit–risk decisions.
Deep knowledge of global PV regulations, standards, and safety deliverables (e.g., RMPs, PSURs/PSRs), and experience contributing to global regulatory submissions and interactions with major agencies.
Strong matrix leadership and influencing skills withcross‑functionalleaders (e.g., Clinical Development, Medical Affairs, Regulatory Affairs), including representation at senior governance.
Demonstratedpeopleleadership: ability to lead, coach, and mentor safety physicians/scientists; excellent communication skills with the ability to present complex topics to senior leaders.
Ability to travel domestically and internationally, as business needs require.
Desirable for the role
PhD or other advanceddegreein a relevant scientific discipline.
Research experience in the GCT field.
Medical specialty, or documented training, in oncology and/or haemato-oncology.
Basic and/or Translational Research background, including authoring peer reviewed publications.
Good knowledge of PV regulations in China, Australia, Japan, rest of Asia.
Recognizedsubject‑matterexpertiseand sound independent judgment in clinical safety; disease area safety leadership experience.
Experience speaking at industry conferences and shaping external safety messaging.
Experience supportingin‑licensing/due diligence from a safety perspective.
Proven ability to embed new processes/systems and drive continuous improvement in safety ways of working.
Date Posted
06-May-2026Closing Date
19-May-2026AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
Rejoignez notre réseau de talents
Inscrivez-vous pour recevoir des alertes emplois AstraZeneca.
S'inscrire
