Collects and assesses adverse-event information for marketed and investigational products, manages global safety-database data, supports regulatory compliance and inspections, and answers case-report queries.
About this role
This associate director role sits in Research and Development's vaccine clinical development function. It provides medical and scientific oversight for clinical trials, primarily supporting Japan and Asia-Pacific, and contributes to strategies for compounds seeking approval in those markets.
The clinician supports protocol design and feasibility, risk mitigation, and safety surveillance under the Safety Surveillance Review Plan. Duties include reviewing individual and cumulative safety data, contextualizing adverse events, interpreting efficacy and safety findings, coordinating with study teams and CROs, training investigators, and contributing to clinical reports, regulatory documents, PMDA interactions, and DMC or steering committee reviews.
Applicants must hold an M.D. or equivalent and have independently used a prescribing license for at least one year after internship or house-officer training, including at least one year in patient care. The role requires critical evaluation of medical and scientific information, understanding of clinical program design, development and execution, and adaptability in a changing environment.
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