Clinical Development Lead (Japan) / Senior Clinical Scientist
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Job description
About the role
GSK is looking for a Clinical Development Lead (CDL) in Japan, who is the single point of accountability for all clinical development of assigned assets. The CDL defines and delivers Japan's clinical strategy, drives innovation and decision making, ensures compliance and quality, and leads cross-functional teams. The role may also cover Clinical Scientist responsibilities when no CS is assigned.
Key responsibilities
- Define and execute Japan's clinical development strategy and local adaptations of global strategies, delivering differentiated medicines and vaccines.
- Lead benefit-risk assessments and advise central CDL, senior management and governance boards on position, go/no-go decisions and risk mitigation.
- Provide matrix leadership across Japan clinical functions (clinical science, operations, medical writing, biostatistics, data management) and oversee quality and on-time delivery.
- Resolve disputes within the Japan clinical team and act as a peer to central CDLs to align global strategy.
- Promote innovative approaches such as adaptive designs, digital endpoints and decentralised elements, and represent Japan clinically internally and externally.
- Mentor Clinical Scientists and colleagues to build a high-performing team.
Required profile
- Japanese medical license (MD).
- Clinical development experience in pharma or vaccines (ideally 3-5+ years) or clinical research experience.
- Experience interacting with Japanese regulators (PMDA/MHLW) and local stakeholders.
- Proven ability to lead matrixed teams and track record in clinical strategy, study design and benefit-risk assessment.
- Legal right to work in Japan.
- Fluent Japanese and business-level English.
Required skills
- Clinical development and clinical trial design, including familiarity with digital and remote approaches.
- Matrix leadership, project management and risk management.
- Preferred: CTMS knowledge.
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