Clinical Scientist, Senior CS or JCDL
Core
Define and execute Japan clinical development strategy for medicines/vaccines, ensuring compliance, quality, and alignment with global plans to deliver patient value.
Role type
Senior Clinical Development Lead (Japan)
Builds
Japan clinical programs for specialty medicines and vaccines
Domain
Biopharmaceuticals / Vaccines / Clinical Development
Deliverable
client delivery
Required skills
Clinical strategy development, study design, benefit-risk assessment, regulatory interaction (PMDA/MHLW), matrix leadership, therapeutic expertise, risk management, operational delivery, team coaching
Preferred skills
Innovative trial design (adaptive, digital endpoints), digital/remote approaches, stakeholder negotiation
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Define and execute Japan clinical development strategy; Lead benefit-risk assessments and provide recommendations on go/no-go decisions; Provide matrix leadership across Japan clinical functions; Resolve disputes within the Japan clinical team; Promote innovative approaches to improve value and efficiency; Oversee clinical development activities to ensure quality and on-time delivery; Coach and mentor Clinical Scientists and colleagues
Seniority
Senior, hands-on IC with strategic leadership
