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, Investigator’s 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.
  

Requirements

• 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 bachelor’s 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.