Global Safety Program Lead Cell Therapy Oncology & Onco-Hematology

As aGlobal 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 oncologyspecifically 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 Therapyfor theendtoendsafety strategy delivery and oversight ofAZD0120 Multiple Myelomaprogram and potentially otherassetsacrosspreclinical clinical andpostmarketing. 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 ensuringhighquality compliant delivery of safety activities.

• Own the scientific and clinical safety content for the asset(s) including safety TPP safety Go/NoGocriteria toxicity management guidelines and safety messaging integrating inputs from clinical epidemiologypreclinical and literature.

• Represent Global Patient Safety at key governance and external forums (e.g. DRCeCRC 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 andpostmarketingsurveillance to inform labeling and risk minimization.

• Build andmaintainstrong internal and external networks including alliance partners to drive proactivecrossfunctionalsolutionorientedsafety actions; may support due diligence andinlicensingassessments.

• 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 qualityGxP 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 preandpostlaunch.

• Proventrack recordof leading asset safety strategy and delivery withdemonstratedstrategic influence on clinical studies/programs and benefitrisk 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 withcrossfunctionalleaders (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.

• Goodknowledge of PV regulationsin China Australia Japan rest of Asia.

• Recognizedsubjectmatterexpertiseand sound independent judgment in clinical safety; disease area safety leadership experience.

• Experience speaking at industry conferences and shaping external safety messaging.

• Experience supportinginlicensing/due diligence from a safety perspective.

• Proven ability to embed new processes/systems and drive continuous improvement in safety ways of working.