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 strategic oversight for patient safety in oncology/haemato-oncology cell therapy programs, reporting to the Cell Therapy Oncology Global Safety Project Lead. Serve as a senior leader within the Cell Therapy Patient Safety Unit, coaching junior staff and ensuring compliance with Good Clinical and Pharmacovigilance Practice and regulatory requirements.

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 deliverables
• Safety contribution to study designs and study concept delivery within assigned study/program
• Collaborating with PS team members to undertake safety surveillance activities and prepare high quality evaluation documents describing safety findings including safety signal validation
• Providing expert input to safety-relevant elements of study design and interpretation, including use of digital/AI tools for adverse event visualization and disproportionality analysis
• Leading project discussions with governance boards, including interactions with the Patient Safety Review Board
• Leading safety strategy for regulatory communication and oversight of higher-level documents to support submission activities
• Leading medico-scientific contributions to risk management plans, periodic reports (PBRERs, DSURs)
• Authoring safety-related aspects of the Target Product Profile and internal Go/No-Go Investment Decisions for CTG products
• Participating in advisory discussions to support other Patient Safety teams and representing Patient Safety in cross-functional discussions with internal and external partners
• May be required to support in-licensing opportunities

Qualifications

• Medical Degree or equivalent
• 3+ years of proven clinical experience as a physician or academic clinician
• Extensive pharmacovigilance experience with demonstrated high standards and understanding of medico-legal aspects of pharmacovigilance
• Detailed understanding of pharmaceutical safety, reporting, and surveillance processes with strong experience in patient safety related to clinical trials and marketed products
• Experience designing and overseeing clinical studies with a focus on patient safety, including AE monitoring, safety data review, signal detection and interpretation
• Strategic leadership experience in Patient Safety of complex drug programs
• Ability to collaborate in a matrixed environment and influence cross-functional leaders
• Proven ability to influence key business partners
• Proficiency in written and verbal communications

Skills

• Oncology or haemato-oncology knowledge; experience in GCT field preferred
• Experience with AI tools and digital safety analytics
• Strong collaboration and cross-functional influencing capabilities
• Excellent scientific and clinical writing skills

Education

• Medical Degree or equivalent

Additional Requirements

• Experience across therapeutic areas and functions; ability to work in global regulatory environments