Clinical Leader (Clinical Development Scientist I / II), Immunology
Core
Lead the formulation of clinical development strategies for immunology assets in Japan, focusing on identifying unmet medical needs and aligning with global strategies and regulatory requirements.
Role type
Senior Clinical Development Scientist (Immunology)
Builds
Japan Clinical Development Plans (JCDP), regulatory submission strategies, and clinical study reports for immunology products.
Domain
Biopharmaceuticals, Immunology, Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical development strategy, regulatory affairs (PMDA), key opinion leader (KOL) management, clinical study oversight, medical writing, cross-functional team leadership, conflict resolution, scientific rationale development, subject safety management
Preferred skills
Medical Doctor, Veterinarian, or Pharmacist license, Master's or PhD degree, experience in immunology therapeutic area
Technologies
None explicitly listed as tools/frameworks
Responsibilities
Formulate clinical development strategies by managing KOLs and analyzing academic conference data; Lead the creation of the Japan Clinical Development Plan (JCDP) ensuring regulatory compliance and unmet need alignment; Facilitate discussions with global teams and regulatory authorities to resolve clinical issues; Interpret clinical study results to develop submission strategies and prepare the clinical section of the CTD; Oversee study timelines and ensure subject safety in collaboration with monitoring and safety teams; Lead cross-functional Clinical Working Teams and prepare key study documents.
Seniority
Senior, hands-on IC with mentorship responsibilities
