Clinical Development Lead
Core
Owns the overall Japan clinical development plan, ensuring studies fit Japan-specific clinical, regulatory, and operational requirements while aligning with global strategy.
Role type
Senior IC clinical development lead (Japan)
Builds
Japan-specific clinical development strategies, study protocols, and regulatory submission documents for assigned projects.
Domain
Biopharmaceuticals, Clinical Development, Japan Market
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical development experience in biopharmaceuticals, regulatory agency interaction (PMDA), study feasibility assessment, CRO and vendor selection, risk mitigation, scientific presentation at academic conferences
Preferred skills
MD/PhD/PharmD, experience with therapeutic area opinion leaders, strategic and critical thinking
Technologies
None stated
Responsibilities
Develop Integrated Development Plan (IDP) for Japan, lead clinical studies as owner, manage local protocol amendments, secure resources and budget, identify study risks, solve study issues including AE management, prepare regulatory submission documents, establish scientific reputation in academic societies
Seniority
Management level
