Associate Medical Director, Patient Safety Physician, Cell Therapy – Long-Term Follow-Up (LTFU)

Role Summary

Associate Medical Director, Patient Safety Physician, Cell Therapy – Long-Term Follow-Up (LTFU) leads within the Cell Therapy Patient Safety Unit (CTPSU), providing medico-scientific and clinical strategic leadership in long-term benefit-risk assessments for AstraZeneca cell therapies in oncology. Acts as a coach/mentor to junior Patient Safety staff and ensures compliance with Good Clinical and Pharmacovigilance Practice and regulatory requirements.

Responsibilities

• Providing strategic Long Term Patient Safety input to CGT drug development programs as part of a global matrix team with high-quality contribution to Safety & Strategy Management Team (SSaMT) deliverables
• Responsible for safety contribution to long-term follow-up (LTFU) study designs and study concept delivery within their assigned study/program
• Collaboration with PS team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings including LTFU safety signal validation
• Ensuring expert input to LTFU safety-relevant elements of study design and interpretation, including efficient use of digital/AI tools and methodology (e.g. adverse event visualization and disproportionality analysis)
• Providing leadership to support project discussions with governance boards, including interactions with Patient Safety Review Board
• Leading the cell therapy LTFU strategy for regulatory communication and provide oversight of higher-level documents to support submission activities for assigned studies/products
• Leading medico-scientific contributions to risk management plans (RMPs) for assigned products and to Periodic Reports, including PBRERs, DSURs
• Authoring and accountable for the LTFU-related aspects of the Target Product Profile (TPP) and internal Go/No-Go Investment Decisions (ID) for the CTG product throughout its lifecycle
• Participating in advisory discussions to support other Patient Safety teams in the development of their safety strategy and may represent Patient Safety in cross-functional discussions with internal and external partners
• May be required to support in-licensing opportunities

Qualifications

• Medical Degree or equivalent
• Understanding of the medico-legal aspects of cell therapy LTFU
• Understanding of pharmaceutical safety, reporting, and surveillance processes with strong experience of Patient Safety related to clinical trials and marketed products
• Experience in designing, overseeing, and implementing clinical studies with a focus on patient safety, including adverse event monitoring, safety data review, signal detection and evaluation, and interpretation of trial results to inform benefit‚Äìrisk assessments and safety labeling
• Capacity to collaborate across a matrixed environment and influence cross-functional leaders on decision-making
• Ability to influence key business partners within and outside of the company
• Proficiency with both written and verbal communications
• Experience with AI tools

Additional Preferred Expertise

• Research experience in the GCT field
• Medical specialty, or training, in oncology, immunology, or rare diseases
• 2+ years of proven clinical experience
• Experience in pharmacovigilance with evidence of delivering to a high standard
• Strategic leadership expertise in Cell Therapy Patient Safety
• Cross-therapeutic area (TA) expertise and commercial understanding
• Able to work across TAs and functions
• Basic and/or Translational Research background, including authoring peer-reviewed publications
• Knowledge of PV regulations in China, Australia, Japan, rest of Asia