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Job Description

メルクと一緒に、あなたの力を発揮しよう！

冒険、限界への挑戦、そして発見に焦がれるあなたへ。あなたの大志を、メルクで羽ばたかせましょう！科学とテクノロジーを駆使したイノベーションに情熱を注ぐメルクのスタッフは世界中で活躍中です。ヘルスケア、生命科学、エレクトロニクスの分野で、メルクのソリューションは人々の暮らしをますます豊かなものにしています。あなたとメルクの力を合わせて、大きな夢を抱きましょう。メルクは、人、顧客、患者、そしてこの地球という惑星が共存する豊かな世界の構築に情熱を注いでいます。このためメルクでは、好奇心にあふれた人材を募集中です。メルクと一緒に、想像を超えた世界を開拓しませんか？

MEDICAL DIRECTOR or Clinical Scientist (Immunology experience required)

YOUR ROLE

Act as a medical responsible:

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

Act as a clinical representative in global project/regional team:

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

Act as a clinical representative in global project/regional team:

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)

WHO YOU ARE

Must have at least three years of experience in clinical development in the field of immunology at a pharmaceutical company.
Fluent in English with native Japanese language skills.
A strong scientific background is required, with a bachelor's degree in pharmacology, biology, or a related field at minimum, and preferably a Ph.D. for the Clinical Scientist role. (MD degree is required for the Medical Director position)
Ability to work effectively within a team.
Availability for evening-to-night calls to discuss programs/studies with Europe/US-based colleagues.
Willingness to visit Key Opinion Leaders (KOLs) and investigators when necessary
Effectively drive projects even in uncertain and ambiguous situations

About Merck Group

This channel is not intended for U.S. and Canadian visitors. Merck operates in the U.S. and Canada as EMD Serono in Healthcare, MilliporeSigma in Life Science and EMD Electronics in Electronics. An unaffiliated and unrelated company, Merck & Co., Inc., Kenilworth, NJ, US holds the rights in the trademark MERCK in the U.S. and Canada.

_______________________________

We are Merck, a leading global science and technology company headquartered in Germany.

We are curious explorers, courageous pioneers, and ingenious inventors. Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Life Science, Healthcare, and Electronics.

Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and the planet.

We believe in the positive power of science and technology. It has determined our actions since 1668 and inspires us to continue researching for a future worth living. As a family-owned company with over 350 years of experience, we stand for sustainability, responsibility, and innovative strength.

We take pride in being a diverse and inclusive company that values and fosters the talents and abilities of our employees. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Work your Magic and join Merck.

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Data Privacy Declaration: www.merckgroup.com/en/privacy-statement

Industry

Chemicals & Materials

Company Size

10,000+ employees

Headquarters

Darmstadt, DE

Year Founded

Unknown

Website

merckgroup.com

Social Media

Medical Director or Clinical Scientist (Immunology experience required) / Biopharma

Job Description

About Merck Group