Clinical Leader (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), regulatory submission strategies, and clinical study reports
Domain
Pharmaceuticals and Medical Devices (Eye Care-Specialty-Aesthetics)
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, cross-functional team leadership, medical writing, clinical study oversight
Preferred skills
Medical Doctor, Veterinarian, or Pharmacist license, Master's or PhD degree
Technologies
CTD, TPP
Responsibilities
Formulate clinical development strategies based on medical/scientific rationale and regulatory considerations; Lead preparation of Japan Clinical Development Plan (JCDP); Manage discussions with global teams and regulatory authorities; Interpret clinical study results and develop submission strategies; Oversee study timelines and ensure subject safety; Prepare key study documents; Lead cross-functional Clinical Working Team
Seniority
Senior, hands-on IC
