■ Work content
General internal medicine (preferably if you have a specialized area (cancer area))
[Supplement to work contents]
Supports the Global Medical Lead (GML) and may participate as an adhoc member of an Core Team or may serve as a GML in small projects after having gained sufficient experience as an ad-hoc GML. May act as GML for small early stage projects with supervision.
Provides input into clinical protocols and ensures protocol meets strategic program objectives in cooperation of GML and study team.
Responsible for medical and safety monitoring and review of data for enrolled subjects in on-going studies. Reviews, assesses and reports on safety data for subjects in clinical study.
Interfaces with principal investigators, consultants, advisors, regulatory bodies, ethics committees and safety monitoring boards.
Contributes on assigned clinical trials to design, implement, conduct and interpret clinical studies to support decisions to advance or halt development of a new drug or to successful filing regulatory submissions.
Contributes to the execution and delivery of the clinical development plan.
Acquires publicly available knowledge of competitor products and clinical plans.
Negotiates milestones and contributes to meeting clinical development objectives.
Contributes to Global Project Team meetings.
Responsible for keeping Global Development Project Lead (GDPL), other project physicians and Vice President Medical Science Therapeutic Area Head informed of clinical progress and any critical clinical issues and especially the emerging safety profile
Contributes to clinical documents: protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions.
Incorporates Health Economics Outcomes Research requirements into protocol design.
・ Japanese doctor license. PhD is a plus.
・ 3 years or more of clinical experience is required
・ Experience involved in clinical trials at companies or research
・ English business level
・ Clinical research experience
■ Working date and time
Day shift: 5 days a week
* Working without shift is possible
Weekdays: 08: 45-17: 45 (standard working hours, flextime system available)
■ Working conditions
Basic salary: 12 million yen ~ (approximate amount * depends on experience and skills)
■ Work place
■ Application guidelines
There is an interview
■ Dr. Navi management company
M Stage Co., Ltd.
To a doctor consultant
□ Contact information
Tokyo Head Office
2-1-1 Osaki, Shinagawa-ku, Tokyo ThinkPark Tower 5F
General Internal Medicine, Others, Companies
Dr. Job Change Navi