Japan Clinical Development, Senior Manager

Japan Development Lead

Role Overview

Lead Japan clinical development strategy for assigned products, translating global development plans into effective Japan-specific clinical and evidence-generation strategies.

The role also leads a cross-functional Japan Product Strategy Team, working closely with Clinical, Medical, Regulatory, Value & Access, Commercial, and Development Operations teams to support successful development, registration, and commercialization in Japan.

Key Responsibilities

• Lead Japan Clinical Development and Evidence Generation Plans in alignment with global strategy.
  
• Provide Japan-specific clinical and medical insights on treatment guidelines, unmet needs, and clinical development.
  
• Partner with Regulatory, Safety, Value & Access, and Development Operations on clinical and regulatory activities.
  
• Provide clinical input into PMDA interactions, regulatory submissions, and NDA activities.
  
• Lead cross-functional Japan product strategy and align stakeholders around key priorities.
  
• Support clinical studies through investigator meetings, site activities, inspections, and other medical/scientific activities.
  
• Coach and support team members and promote effective cross-functional collaboration.
  

Requirements

Requirements

• 5+ years of clinical development experience in the biopharmaceutical industry.
  
• Experience leading clinical development projects or cross-functional development teams.
  
• Experience working on global clinical development programs and adapting strategies for Japan.
  
• Strong understanding of Japanese clinical development, PMDA regulations, and drug development processes.
  
• Experience with NDA filing and/or early-phase clinical development preferred.
  
• Strong cross-functional leadership and strategic thinking skills.
  
• Medical degree, PhD, Master’s, or equivalent relevant experience.
  
• Fluent English and business-level Japanese.