Clinical Leader (Senior Clinical Development Scientist or Assistant Medical Director), Hematology Oncology
Core
Lead end-to-end clinical development strategy and execution for hematology/oncology assets in Japan, from planning to regulatory approval, integrating medical evidence with business and regulatory requirements.
Role type
Senior Clinical Development Scientist (Senior CDS) / Assistant Medical Director
Builds
Japan Clinical Development Plans (JCDP), regulatory submissions (CTD), and strategic clinical assessments for in-licensed products
Domain
Hematology Oncology, Clinical Development, Regulatory Affairs (Japan/PMDA)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical development strategy formulation, regulatory affairs (PMDA), risk management, cross-functional leadership, stakeholder negotiation, clinical data interpretation, submission strategy design
Preferred skills
Experience with in-licensed products, global team alignment, crisis management for safety/adverse events
Technologies
CTD, JCDP, IEST, TAPR, AST
Responsibilities
Formulate and execute Japan-specific clinical development strategies; lead preparation of Japan Clinical Development Plan (JCDP); manage multiple complex projects and set priorities; interpret clinical study results and develop submission strategies; lead discussions with global teams and regulatory authorities; resolve conflicts and manage external issues with medical institutions or authorities; ensure subject safety and study timelines; lead the JAST Clinical Working Team
Seniority
Senior, hands-on IC