Senior Manager, Clinical Development

Position Overview

Lead clinical development activities in Japan, including development strategy, clinical trial execution, and collaboration with global and local cross-functional teams. The role will provide scientific and strategic leadership to accelerate the development and delivery of innovative treatments in Japan.

Key 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

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