Clinical Leader (Clinical Development Scientist I / II), Immunology
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 (Immunology)
Builds
Japan Clinical Development Plan (JCDP), clinical study reports, and regulatory submission strategies for immunology assets.
Domain
Life Sciences / Immunology / Clinical Development
Required skills
Clinical development strategy formulation, regulatory affairs (PMDA), key opinion leader (KOL) management, clinical study oversight, medical writing, cross-functional team leadership, conflict resolution, scientific data interpretation
Preferred skills
Medical Doctor, Veterinarian, or Pharmacist license, Master's or PhD degree, experience in immunology therapeutic area
Technologies
CTD, TPP guidelines, clinical study management tools
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 (PMDA); oversee execution of clinical study timelines and subject safety; prepare key study documents including clinical study reports; lead cross-functional Clinical Working Teams; educate lower-grade colleagues and internal staff.
Seniority
Senior, hands-on IC with mentorship responsibilities
