Clinical Development Scientist I / II, Eye Care-Specialty-Aesthetics
Core
Lead clinical development strategies for novel pharmaceutical products and medical devices in Japan, ensuring regulatory compliance and addressing unmet medical needs.
Role type
Senior Clinical Development Scientist (Japan)
Builds
Japan Clinical Development Plan (JCDP), clinical study reports, and regulatory submission strategies.
Domain
Pharmaceuticals and Medical Devices, 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), key opinion leader (KOL) management, clinical study oversight, medical writing, cross-functional team leadership
Preferred skills
Medical Doctor, Veterinarian, or Pharmacist license, Master's or PhD degree
Technologies
Clinical Trial Management Systems, Regulatory Submission Platforms
Responsibilities
Formulate clinical development strategies based on medical/scientific rationale and regulatory considerations; Lead the preparation of the Japan Clinical Development Plan (JCDP); Manage external key opinion leaders (KOLs) and collect information at academic conferences; Lead discussions with global teams and regulatory authorities on clinical issues; Interpret clinical study results and develop submission strategies; Oversee study timelines and ensure subject safety; Prepare key study documents including clinical study reports.
Seniority
Senior, hands-on IC
