Medical Director, Patient Safety Physician, Cell Therapy - Immunology

Role Summary

Medical Director, Senior Patient Safety Physician, Cell Therapy Immunology. Lead medico-scientific and clinical strategy for patient safety in immunology and autoimmune diseases within AstraZeneca's cell therapy program. Provide leadership, mentorship, and ensure 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 (SSaMT) deliverables
• Responsible for safety contribution to 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 safety signal validation
• Ensuring expert input to safety-relevant elements of study design and interpretation, including efficient use of digital/Artificial Intelligence 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 safety 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 Safety-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; representing Patient Safety in cross-functional discussions with internal and external partners
• May be required to support in-licensing opportunities

Qualifications

• Required: Medical Degree or equivalent
• Required: 1+ years of proven clinical experience as a physician or academic clinician
• Required: 1+ years of drug development/patient safety experience
• Required: Detailed understanding of pharmaceutical safety, reporting, and surveillance processes with strong experience of Patient Safety related to clinical trials and marketed products
• Required: 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
• Required: Ability to collaborate across a matrixed environment and influence cross-functional leaders on decision-making
• Required: Proficiency with written and verbal communications
• Preferred: MSc/PhD in scientific discipline
• Preferred: Immunology specialty or training in immunology and/or autoimmune diseases
• Preferred: 2+ years of proven clinical experience
• Preferred: Immunology therapeutic area expertise and commercial understanding
• Preferred: Strategic leadership experience in Patient Safety of complex drug programs
• Preferred: Knowledge of PV regulations in multiple regions

Skills

• Clinical judgement and medical leadership
• Safety signal detection and risk assessment
• Regulatory and compliance awareness
• Cross-functional collaboration and influence
• Communication of complex scientific information
• Technology-enabled safety analytics (AI tools, data visualization)

Education

• Medical Degree or equivalent
• Advanced degree or training in immunology or related field preferred

Additional Requirements

• Experience with cross-functional teams and governance boards