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), clinical study reports, and regulatory submission strategies for Allergan Aesthetics portfolio.
Domain
Life Sciences / Clinical Development / 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, conflict resolution, study timeline oversight, subject safety management
Preferred skills
Medical Doctor, Veterinarian, or Pharmacist license, Master's or PhD degree, experience in immunology, oncology, or neuroscience
Technologies
CTD, TPP
Responsibilities
Formulate clinical development strategies based on medical/scientific rationale and regulatory considerations; lead preparation of Japan Clinical Development Plan (JCDP); conduct 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