[R&D] Japan Clinical Leader
Core
Lead clinical development of assigned projects in Japan, formulating strategies with global teams and obtaining regulatory approval.
Role type
Senior Clinical Leader (Japan)
Builds
Clinical development plans and strategies for pharmaceutical products in the Japanese market
Domain
Pharmaceutical R&D / Clinical Development
Deliverable
client delivery
Required skills
Clinical development strategy design, regulatory submission expertise, team leadership, stakeholder management (KOLs, academic societies), document preparation and review, safety data analysis, committee management (IDMC, AC)
Preferred skills
Advanced medical and pharmaceutical knowledge, clinical study operations, logical and innovative thinking, negotiation and consensus building, project management
Technologies
CTD, study outlines, briefing documents, investigator's brochures, risk management plans
Responsibilities
Evaluate candidates for development and formulate effective Japan development plans; establish relationships with internal and external stakeholders to expedite approval; lead the Japan Development Team and clinical studies; prepare and review high-quality clinical documents; review clinical data and protocol deviations; manage independent data monitoring and safety review committees
Seniority
Senior, hands-on IC with team leadership
