Clinical Scientist, Senior CS or JCDL
On-siteTokyo, Tokyo, Japan
Job Summary
Define and execute Japan clinical development strategy, leading benefit–risk assessments to inform go/no-go decisions and risk mitigation for assigned assets. Provide matrix leadership across clinical functions to ensure integrated planning, resolve internal disputes, and align local efforts with global clinical development strategy. Coach and mentor clinical colleagues to build a high-performance team while promoting innovative approaches such as adaptive designs and digital endpoints. Represent Japan clinical development internally and externally, ensuring quality and on-time delivery of regulatory milestones and submissions. Operate in a matrixed environment requiring occasional domestic and international travel for regulatory meetings and investigator sites.
Required Qualifications
- Significant clinical development experience in the pharmaceutical or vaccine industry (typically 5–8+ years), including leadership of Japan clinical programs
- Demonstrated experience interacting with Japanese regulators (PMDA/MHLW) and local stakeholders
- Advanced degree in medicine, pharmacy, life sciences or equivalent (MD preferred)
- 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
- Fluent in Japanese and business-level English (speaking and writing)
- 日本での就労資格を有すること
Desired Qualifications
- Master's degree in medicine, pharmacy, life sciences or equivalent (MD preferred)
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