Medical Director, Senior Patient Safety Physician, Cell Therapy - Oncology

Role Summary

Medical Director, Senior Patient Safety Physician, Cell Therapy Oncology. Lead medico-scientific and clinical strategy for patient safety in oncology/haemato-oncology cell therapies; provide leadership within the Cell Therapy Patient Safety Unit; ensure compliance with Good Clinical and Pharmacovigilance Practice and regulatory requirements; coach and mentor junior staff.

Responsibilities

• Providing strategic 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
• Safety contribution to study designs and study concept delivery within their assigned study/program
• Collaborate with PS team members to undertake safety surveillance activities and prepare high quality evaluation documents describing safety findings including safety signal validation
• Ensure expert input to safety-relevant elements of study design and interpretation, including use of digital/AI tools for adverse event visualization and disproportionality analysis
• Provide leadership to support project discussions with governance boards, including interactions with Patient Safety Review Board
• Lead the safety strategy for regulatory communication and oversee higher-level documents to support submission activities for assigned studies/products
• Lead medico-scientific contributions to risk management plans (RMPs) for assigned products and to Periodic Reports (PBRERs, DSURs)
• Author and be accountable for safety-related aspects of the Target Product Profile (TPP) and internal Go/No-Go Investment Decisions for the CTG product across its lifecycle
• Participate in advisory discussions to support other Patient Safety teams and may represent Patient Safety in cross-functional discussions with internal/external partners
• May support in-licensing opportunities

Qualifications

• Medical Degree or equivalent
• 3+ years of proven clinical experience as a physician or academic clinician
• Extensive experience in pharmacovigilance with evidence of delivering to a high standard; understanding of medico-legal aspects of pharmacovigilance
• Detailed understanding of pharmaceutical safety, reporting, and surveillance processes with strong experience in patient safety for clinical trials and marketed products
• Experience in designing, overseeing, and implementing clinical studies with focus on patient safety, including AE monitoring, safety data review, signal detection and evaluation, and interpretation of trial results for benefit‚Äìrisk assessments and safety labeling
• Strategic leadership expertise in patient safety of complex drug programs
• Ability to collaborate across a matrixed environment and influence cross-functional leaders
• Proven ability to influence key business partners inside and outside the company
• Proficient written and verbal communication

Additional Preferred Expertise

• Research experience in the CGT field
• Medical specialty or training in oncology or haemato-oncology
• 5+ years of proven clinical experience
• Oncology therapeutic area expertise and commercial understanding
• Extensive general medical knowledge
• Ability to work across therapeutic areas and functions
• Experience using AI tools
• Translational research background and peer-reviewed publications
• Knowledge of PV regulations in China, Australia, Japan, rest of Asia