Director, Medical Affairs Oncology

Return to search Apply Now
Published:   2022/02/16


Full time




*This role requires native level Japanese and Business English*



To lead the development of innovative drugs and treatments to patients by providing medical knowledge and experiences for clinical development strategy.

Role and Responsibility:

  • Provide medical advice in a cross functional team such as Japan product team
    • Provide medical knowledge during preparation of clinical development strategy plans.
    • Contribute to interaction with PMDA and key opinion leaders (KOLs) by providing medical and scientific perspectives.
  • Medical inputs in execution of clinical study
    • Provide Japanese medical information such as epidemiology data, standard of care, and /or guideline during protocol development
    • Provide medical suggestions or inputs regarding safety issues and contribute implementation of global study.
  • Tasks related to NDA and other activities
    • Review Japanese CTD (CSE, CSS) and confirm if the contents are medically appropriate. 
    • Contribute preparations of query response for PMDA by providing medical knowledge
    • Attend a meeting led by medical department such as a advisory board meeting prior a drug approval
    • Therapeutic Area Medical Director (TA MD) in a GCP related organization
    • TA MD is responsible for a study design, eligibility criteria, safety management, and safety/efficacy assessments, and also responsible for conducting the study in accordance with the protocol and operation manual.
    • TA MD is responsible for discussion with PMDA and KOLs
    • TA MD is responsible for the contents of CSR 

Background/Experience Mandatory:

  • Sufficient and medical knowledge in the therapeutic area assigned
  • General knowledge of pharmaceutical association (Seiyaku kyo and Pharma etc.).
  • TOEIC score is 800 or higher, or equivalent skill for English communication.


  • Experience of participating in company-sponsored clinical studies as investigators
  • Knowledge regarding process of New Drug Application (NDA) and approval from making clinical development plan (PMDA consultation, Protocol preparation, Study management, CTD preparation, response to PMDA queries after NDA etc.)


  • At least 5 year experience of medical practice (Associate Professor or equivalent is preferable)
  • Having experience in clinical development would be preferable


  • PhD or MD preferred
  • Masters Required

Additional Information:

  • Reports to Head of Medical
  • Global Grade of Director
  • Fast track promotion pathway potentially available
  • Frequent communication with Global counterparts