Medical Director, Patient Safety Physician, Cell Therapy - Immunology

Role Summary

Medical Director, Senior Patient Safety Physician, Cell Therapy Immunology. Lead medico-scientific and clinical strategic oversight for cell therapy immunology safety, provide expert benefit-risk assessments, and mentor junior Patient Safety staff within the Cell Therapy Patient Safety Unit. Ensure compliance with Good Clinical and Pharmacovigilance Practice and regulatory requirements.

Responsibilities

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

Qualifications

• Medical Degree or equivalent
• 1+ years of proven clinical experience as a physician or academic clinician
• 1+ years of drug development/patient safety experience
• Detailed understanding of pharmaceutical safety, reporting, and surveillance with experience in clinical trials and marketed products
• Experience designing, overseeing, and implementing clinical studies with a focus on patient safety, including AE monitoring, safety data review, signal detection and evaluation
• Ability to collaborate across a matrixed environment and influence cross-functional leaders
• Demonstrated ability to influence key business partners
• Proficiency in written and verbal communications

Skills

• Strategic leadership in Patient Safety for complex drug programs
• Safety data analysis, risk assessment, and regulatory communications
• Cross-functional collaboration and stakeholder management
• Proficiency with digital/AI tools for safety analysis

Education

• Medical Degree or equivalent
• Preferred: MSc/PhD in scientific discipline

Additional Requirements

• Immunology or autoimmune disease expertise (preferred)
• Experience in GCT (cell/gene therapy) field (preferred)
• Knowledge of PV regulations in multiple regions (preferred)