Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
3 Years
Description
- Define and execute Japan clinical development strategy and local adaptations of global strategies, informed by deep asset/disease expertise, to deliver differentiated medicines/vaccines of value to patients, stakeholders and the market.
- Lead benefit–risk assessments and provide evidence based recommendations to central CDL, senior management and governance boards on PoS, go/no go decisions and risk mitigation.
- Provide matrix leadership across Japan clinical functions (Clinical Science, Clinical Operations, Medical Writing, Biostatistics, Data Management, etc.) to ensure integrated planning and robust execution oversight.
- Serve as the accountable decision maker to resolve disputes within the Japan clinical team and escalate where required.
- Act as a peer to central CDLs to align and optimize global clinical development strategy.
- Promote and implement innovative approaches (e.g., adaptive designs, digital endpoints, decentralised elements) to improve value, speed and efficiency.
- Represent Japan clinical development internally and externally
- Oversee clinical development activities to ensure quality and on time delivery.
- Coach and mentor CS and clinical colleagues to develop capability and a high performance team.
- Foster cross functional decision making, timely escalation and shared accountability.
Qualifications
Highest qualification: University
- Japanese medical license (MD)
- Clinical development experience in the pharmaceutical or vaccine industry (ideally 3–5+ years), or experience in clinical research.
- Demonstrated experience interacting with Japanese regulators (PMDA/MHLW) and local stakeholders.
- Proven ability to lead cross functional, matrixed teams and make high impact decisions.
- Track record in clinical strategy development, study design, and benefit–risk assessment.
- Strategic and scientific leadership with strong therapeutic/asset expertise.
- Excellent stakeholder management, negotiation and influencing skills.
- Strong problem solving, risk management and decision making capability.
- Operational delivery focus with attention to quality and compliance.
- Coaching and people development skills; ability to build high performing teams.
- Familiarity with innovative clinical trial design and digital/remote approaches.