Clinical Leader (Senior Clinical Development Scientist or Assistant Medical Director), Hematology
Core
Senior Clinical Development Scientist leading end-to-end clinical development strategy, regulatory approval, and project execution for hematology assets in Japan.
Role type
Senior IC clinical development scientist (Japan)
Builds
Japan Clinical Development Plans (JCDP), regulatory submissions, and clinical strategies for hematology products
Domain
Biopharma, Hematology, Japan regulatory landscape
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical development strategy formulation, regulatory affairs (PMDA), cross-functional leadership, risk management, stakeholder negotiation, clinical data interpretation, submission strategy design
Preferred skills
Experience with in-licensed products, global team alignment, crisis management for medical/regulatory issues
Technologies
CTD, IEST, JAST, TAPR, AST
Responsibilities
Formulate and execute Japan-specific clinical development strategies; lead preparation of Japan Clinical Development Plans (JCDP); manage multiple complex projects and resolve conflicts; interpret clinical study results and develop submission strategies; lead discussions with global teams and regulatory authorities; ensure subject safety and study timelines; prepare key study documents; educate lower-grade staff
Seniority
Senior, hands-on IC
