Clinical Leader (Clinical Development Scientist I / II), Solid Tumor Oncology
Core
Lead clinical development strategies for solid tumor oncology products in Japan, managing execution from planning to regulatory submission.
Role type
Senior Clinical Development Scientist (IC)
Builds
Japan Clinical Development Plans (JCDP), regulatory submissions (CTD), and clinical study reports for novel pharmaceuticals and medical devices.
Domain
Oncology (Solid Tumor), Pharmaceutical Clinical Development, Japanese Regulatory Affairs (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), clinical study oversight, medical writing, cross-functional team leadership, stakeholder management (KOLs, Global teams)
Preferred skills
Medical Doctor, Veterinarian, or Pharmacist license, PhD or Master's degree, experience in solid tumor oncology
Technologies
CTD, TPP guidelines, clinical study management tools
Responsibilities
Formulate clinical development strategies based on unmet medical needs and regulatory trends; lead the creation of the Japan Clinical Development Plan (JCDP); manage external Key Opinion Leaders (KOLs) and academic conferences; interpret clinical study results and develop submission strategies; oversee study timelines and subject safety; prepare clinical sections of CTD and respond to regulatory inquiries; lead cross-functional Clinical Working Teams.
Seniority
Senior, hands-on IC (G17/G18)