Medical Director, Clinical Development (Oncology)

Medical and Scientific Leadership

• Provide medical/scientific expertise and contribute to the development and review of clinical documents including study concept sheets protocols clinical study reports Investigators Brochures publications and other relevant materials.
  
• Review and approve clinical documents related to assigned clinical studies to ensure scientific quality and compliance.
  
• Conduct medical monitoring activities for assigned clinical programs as required.
  
• Oversee medical and scientific aspects of clinical trials including identification and management of scientific and medical risks in collaboration with cross-functional teams.
  
• Support the review analysis and interpretation of clinical study data.
  
• Contribute to the communication and publication of study results.
  

Clinical Development Strategy & Cross-Functional Collaboration

• Develop and support clinical development strategies for assigned oncology programs to establish safety and efficacy and support regulatory approval in Japan and globally.
  
• Provide insights into the local medical environment and contribute to regional development strategies.
  
• Collaborate with global teams to develop biomarker strategies and support translational research initiatives.
  
• Contribute to integrated development plans regulatory submission documents publications and other clinical development activities.
  
• Build and maintain strong relationships with investigators Key Opinion Leaders (KOLs) regulatory authorities ethics committees/IRBs consultants and academic institutions.
  
• Participate in cross-functional project teams providing medical/scientific input into business planning project strategy and evaluation of potential development opportunities.
  
• Support business development activities by providing medical expertise for evaluation of strategic opportunities.
  

Global & Regional Team Collaboration

• Act as the clinical representative in global and regional project teams.
  
• Provide medical input into global development strategies and regulatory approaches.
  
• Contribute to clinical sections of regulatory submission documents
  
• Collaborate with international colleagues across different time zones including Europe and the US.
  

• Minimum of 5 years of clinical development experience in oncology within the pharmaceutical industry.
  
• Fluent English communication skills with native-level Japanese proficiency.
  
• Strong scientific background with a minimum bachelors degree in pharmacology biology life sciences or a related field.
  
• Ph.D. preferred for Clinical Scientist candidates.
  
• MD qualification required for Medical Director candidates.
  
• Experience working collaboratively in cross-functional and international teams.
  
• Ability to participate in evening/night calls with global colleagues when required.
  
• Willingness to engage with KOLs and clinical investigators.
  
• Ability to effectively lead projects and make decisions in complex uncertain and evolving environments.