Senior Manager, Senior Japan Clinical Lead

Position Overview

Senior clinical development role responsible for the clinical strategy and development of assigned assets in Japan. The role ensures clinical programs are aligned with Japan-specific medical and regulatory requirements and generate the evidence needed for successful regulatory approval.

Key Responsibilities

• Lead the Japan clinical development strategy across early, late-stage and post-marketing studies.
  
  
  


• Provide clinical input into study design, protocols, execution and data analysis.
  
  
  


• Ensure global clinical programs are appropriate for Japanese medical practice and regulatory requirements.
  
  
  


• Lead clinical discussions with KOLs, investigators and external scientific partners.
  
  
  


• Serve as a key clinical representative in regulatory interactions and support regulatory submissions.
  
  
  


• Review and interpret clinical data, identify risks and trends, and support clinical decision-making.
  
  
  


• For Japan-specific studies, oversee clinical activities from study start-up through completion.
  
  
  


• Work closely with Clinical Operations, Regulatory, Statistics, Medical and Global teams in a matrix environment.
  
  
  


• Contribute to clinical strategy and ensure the development program supports a viable registration strategy in Japan.
  
  
  


• Coach and develop junior Clinical Leads.
  
  

Requirements

Requirements

• 5+ years of clinical development / pharmaceutical industry experience preferred.
  
  
  


• Strong experience in clinical trial design, execution and data interpretation.
  
  
  


• Strong understanding of drug development, GCP/ICH, clinical operations and statistics.
  
  
  


• Experience developing clinical strategies and working within cross-functional/matrix organizations.
  
  
  


• Ability to influence and collaborate with senior stakeholders without direct authority.
  
  
  


• Strong problem-solving and decision-making skills.
  
  
  


• Ability to work effectively in complex and changing environments.
  
  
  


• Business-level English preferred.