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). Lead within the Cell Therapy Patient Safety Unit (CTPSU) to provide medico-scientific and clinical strategic leadership in long term benefit risk assessments for AstraZeneca cell therapies in oncology. Coach and mentor junior Patient Safety staff and ensure processes adhere to regulatory requirements and AZ processes.

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/ artificial intelligence (AI) tools and methodology (e.g. adverse event visualisation 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
• Participate 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 in relevant fields
• 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 company
• Proficiency with both written and verbal communications
• Experienced in using AI tools

Additional Preferred Expertise

• Research experience in the GCT field
• Medical specialty, or documented training, in oncology, immunology, and/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
• Good knowledge of PV regulations in China, Australia, Japan, rest of Asia