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