Medical Doctor Translational Research
Contribtute to Greater Outcomes for Patients across Japan and Overseas
Further Develop your Career as a Medical Expert in Global IMP Development
- Multinational pharmaceutical company specialized in the development of medicines in oncology, immunology, neurology / psychiatric disorders
Propose target indications of a molecule and priorities after experts outreach in collaboration with medical affair/scientific liaison and thorough assessment of opportunities and risks with a team.
Evaluate opportunity and risks for license-in candidate compound, create potential clinical development strategy with a team and write a briefing report.
Create clinical development strategy and high-level integrated development plan with a team after deep analyses of non-clinical and clinical evidence (in-house data and literature), CMC, medical needs, regulatory requirement and operational feasibility.
Write scientific rationale, integrated development plan, clinical protocol synopsis and abstract as needed.
Collaborate with internal staff from multiple functions in the company, consultants and CROs. Communicate with Europe and US.
Attend and support scientific and medical meetings by providing data and scientific background.
- Licensed MD
- Native level Japanese
- Business level English
- Have a wide impact on patients across Japan and further afield
- Meaningful position in a major global company
- Stable career path, overseas experience opportunities
- Expand medical expertise beyond clinical practise to clinical development, medical affairs and pharmacovigilance:
- Clinical Development:
- Oversight, development and execution of clinical studies in line with global strategy. Integrate clinical development objectives with global considerations into strategic business decisions. Ensure clinical, operational and medical governance excellence across all clinical development projects for assigned programs. Lead the preparation of regulatory briefing documents and clinical elements of regulatory submission
documents (IND, CTA, NDA, BLA, MAA)
- Medical Affairs:
- Participate in MSL activities, Data generation (Phase IV, Investigator-initiated studies), Medical Operations, Compliance, Medical Information activities, Training, Medical congress activities and support of investigator-initiated studies. Serve as one of leader team members in global Medical to create grand strategies for global medical activities.
- Work closely with patients, doctors and other healthcare professionals to monitor and report all adverse reactions to ensure the ultimate safety of patients through periodic safety update reports on treatments, writing and reviewing serious adverse effects reports, flagging up early warning signs of adverse effects of drugs, minimising the risk of serious side effects and completing safety audits.