Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
As a vibrant science and technology company, we believe in science as a force for good. We make a positive difference on millions of people´s lives every day.
メルクは、ヘルスケア、ライフサイエンス、エレクトロニクスの分野における世界有数の企業です。サイエンスとテクノロジーへのあくなき探究から生まれる革新的な製品・サービスで人々の豊かな暮らしを創造します。
メルクグループジャパンについて、こちらをご参照ください。
Position Title: (Associate) Medical Director
Department: GCD, Biopharma Japan
Report to: Head of GCD Japan (line manager in Japan)
Team size: 4 (including line manager and open position)
Direct report: 0
KEY ACCOUNTABILITIES
Act as a clinical representative in global project/regional team:
- Provide medical/scientific input and drive/contribute to the creation of relevant clinical documents or parts thereof to ensure high quality of e.g. study concept sheets, study protocols and reports, Investigator Brochures, publications, etc.
- Review and sign off all clinical documents related to the clinical studies (e.g. study protocols and study reports) within area of responsibility
- Conduct medical monitoring for responsible project/study, if applicable
- Oversees all medical scientific aspects of the trial and provides respective guidance to the trial team Oversee all aspects related to the scientific and medical risks in collaboration with the safety representative
- Support the review, analysis and interpretation of study data
- Support communication of study results as assigned
- Propose clinical development strategies in Japan for assigned indication(s)/product(s) in order to establish its safety and efficacy and support registration in the shortest possible time in Japan for information on local medical environment
- Develop Biomarker strategy in collaboration with the global biomarker team
- Propose translational studies in collaboration with the global clinical lead and the biomarker team and facilitate the study.
- Develop, support and/or prepare integrated development plans, submission/registration documents, publications, etc in collaboration with clinical and project team members for assigned indication(s)/product(s)
- Liaise with (principal) investigators, health authorities, IEC/IRB, consultants, opinion/thought leaders and academic institutions within area of responsibility to deliver on key accountabilities.
- Participate in cross-functional development project team activities to provide medical/scientific input into e.g. business plan, project strategy, in-/out-licensing activities and Due Diligence as assigned
- Support business development activities by providing medical-scientific expertise for evaluation of in/out licensing opportunities as appropriate. Provide medical-scientific input to the biomarker strategy in alignment with respective interface functions
STRATEGIC IMPACT
- Propose clinical development strategies for assigned indication(s)/product(s) in order to establish its safety and efficacy and support registration in the shortest possible time worldwide
- Provide medical input to regulatory development strategy and contribute to clinical sections of the Common Technical Document (CTD)
CANDIDATE QULIFICATIONS:
Doctor of Medicine (MD) degree is mandatory.
At least 3 years of experience in pharmaceutical companies, preferably with experience in clinical development. (Experience in Oncology is nice to have but not mandatory.)
- High proficiency in English with native fluency in Japanese.
- A robust scientific background is essential, requiring a minimum of a bachelor's degree in pharmacology, biology, or a related field, and preferably a Ph.D. for the Clinical Scientist position.
- Capable of working collaboratively within a team.
- Availability for discussions with colleagues based in Europe/US during evening-to-night calls.
- Readiness to visit Key Opinion Leaders (KOLs) and investigators when necessary.
Recruiting contact: Fang Liu
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
Register now to our new Talent Zone! It is a great way to stay connected, learn more about our company, career opportunities and events! Even you have no plan to apply a position now, please feel free to register to be visible to our internal recruiters and stay in touch for future opportunities.
メルクグループのタレントゾーンにご登録ください！メルクのポジションにすぐに応募予定のない方も登録可能です。
メルクグループと、メルクにおけるキャリアオポチュニティーについて、理解を深めるいい機会を是非ご活用ください！
Talent zone link: https://careers.vibrantm.com/global/en/jointalentcommunity
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