[R&D] Clinical Development Medical, Associate Director, Research and Development - Vaccines
Core
Provides medical and scientific expertise and oversight for clinical trials worldwide with a primary focus in Japan and the Asia-Pacific region, including protocol design and safety management.
Role type
Associate Director, Clinical Development (Medical)
Builds
Clinical development plans, regulatory documents (JNDA submissions), and clinical study reports for vaccines/compounds.
Domain
Biopharmaceuticals / Vaccines / Clinical Trials
Deliverable
client delivery
Required skills
Medical degree (M.D.), clinical prescribing license, critical evaluation of medical/scientific information, English fluency, Japanese fluency, clinical program design knowledge
Preferred skills
Statistics knowledge, infectious diseases experience, investigational trial experience
Technologies
None stated
Responsibilities
Design development strategies for protocols to obtain regulatory approval in Japan and Asia; provide medical input during protocol development and updates to clinical development plans; ensure documents meet regulatory requirements and company policy; provide study team with medical advice for risk assessment and mitigation planning; perform regular review of individual and cumulative safety data; monitor study safety issues and provide input to serious adverse events (SAEs) reports; participate in the Safety Review Team to evaluate medical benefits/risks; author clinical sections of regulatory documents for JNDA submissions; interact with regulatory authorities (e.g., PMDA), Key Opinion Leaders, and Principal Investigators.
Seniority
Senior, hands-on IC with strategic oversight
