[R&D] Clinical Development Medical, Associate Director, Research and Development - Vaccines
Core
Provide 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 monitoring.
Role type
Associate Director, Clinical Development (Medical)
Builds
Clinical development plans, protocols, regulatory documents (JNDA submissions), and clinical study reports for vaccines.
Domain
Biopharmaceuticals / Vaccines / Clinical Development
Required skills
Medical degree (M.D.), clinical prescribing license, critical evaluation of medical/scientific information, protocol design, safety surveillance, regulatory compliance, stakeholder management, data interpretation, training delivery
Preferred skills
Statistics knowledge, infectious diseases experience, investigational trial experience
Technologies
None stated
Responsibilities
Design development strategies and protocols for Japan/Asia approval; ensure regulatory compliance of study documents; monitor study safety and review adverse events; provide medical input to data analysis and reporting; interact with regulatory authorities (PMDA) and Key Opinion Leaders; support audit and inspection readiness.
Seniority
Senior, hands-on IC with leadership responsibilities