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About the Role
Lead clinical development activities in Japan, providing scientific and strategic leadership to accelerate the development and delivery of innovative treatments.
Responsibilities
- Develop and execute Japan clinical development strategies aligned with global plans and local regulatory requirements.
- Lead clinical trial planning and execution, including feasibility, site selection, recruitment, and CRO management.
- Partner with global and local teams to provide clinical and strategic input throughout development.
- Engage with PMDA on clinical development plans, trial design, submission strategy, and regulatory consultations.
- Support preparation and review of Japanese NDA/CTD documentation.
- Build strong relationships with KOLs, investigators, academic experts, and other external stakeholders.
- Drive effective cross-functional collaboration and operational excellence.
Requirements
- Bachelor’s degree in a scientific discipline; advanced degree preferred.
- MD (Neurology) or Pharmacist background is a plus.
- 10+ years of clinical development experience in pharma and/or CRO, preferably within a pharmaceutical company.
- Experience developing Clinical Development Plans (CDPs).
- Experience in neurology, particularly neurodegenerative diseases, neuroimmunology, or migraine.
- Hands-on experience with PMDA/MHLW.
- Experience managing global and/or Asian clinical trials.
- Strong experience working in global, cross-functional teams.
- People management or team leadership experience is preferred.
- Business-level Japanese and English communication skills.
- Strong understanding of GCP/ICH and Japanese clinical trial regulations.
- Strong communication, presentation, strategic thinking, and stakeholder management skill.
Skills
- Communication
- Presentation
- Strategic thinking
- Stakeholder management
- GCP/ICH
- Japanese clinical trial regulations
Location
- Japan
Work Type
- Full-time
Experience Level
- 10+ years
Education Level
- Bachelor's degree
- Advanced degree
- MD (Neurology)
- Pharmacist