Medical Director, Clinical Sciences
Core
Lead clinical development for Japan programs, adapting protocols and regulatory documents for local requirements while supporting global studies.
Role type
Senior Medical Director (Clinical Development)
Builds
Clinical development programs for serious diseases in Japan
Domain
Biopharmaceuticals, Clinical Development, Japan Market
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design (Phase I-III), Regulatory filing expertise (CTN, J-NDA/J-CTD), Protocol adaptation, Medical writing, KOL/investigator relationship building, Clinical data review
Preferred skills
None stated
Technologies
None stated
Responsibilities
Adapt clinical trial protocols and regulatory documents for Japan-specific requirements; Provide clinical input for regulatory submissions (CTN, J-NDA/J-CTD); Review clinical data and prepare study reports and manuscripts; Assess clinical feasibility for Japan's participation in global studies; Build KOL and investigator site relationships; Represent the company at scientific conferences
Seniority
Senior, hands-on IC
