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About the Role

Act as a medical responsible and a clinical representative in global project/regional teams. Provide medical/scientific input, drive the creation of clinical documents, conduct medical monitoring, and oversee medical scientific aspects of trials. Propose clinical development strategies, develop biomarker strategies, and liaise with investigators, health authorities, and other stakeholders.

Responsibilities

• Provide medical/scientific input and drive/contribute to the creation of relevant clinical documents (e.g., study concept sheets, study protocols and reports, Investigator Brochures, publications).
• Review and sign off all clinical documents related to clinical studies within the area of responsibility.
• Conduct medical monitoring for responsible projects/studies.
• Oversee all medical scientific aspects of the trial and provide guidance to the trial team.
• Oversee all aspects related to scientific and medical risks in collaboration with the safety representative.
• Support the review, analysis, and interpretation of study data.
• Support communication of study results.
• Propose clinical development strategies in Japan for assigned indication(s)/product(s).
• Develop Biomarker strategy in collaboration with the global biomarker team.
• Propose translational studies and facilitate the study.
• Develop, support, and/or prepare integrated development plans, submission/registration documents, and publications.
• Liaise with (principal) investigators, health authorities, IEC/IRB, consultants, opinion/thought leaders, and academic institutions.
• Participate in cross-functional development project team activities to provide medical/scientific input.
• Support business development activities by providing medical-scientific expertise for evaluation of in/out licensing opportunities.
• Provide medical-scientific input to the biomarker strategy.
• Propose clinical development strategies for assigned indication(s)/product(s) worldwide.
• Provide medical input to regulatory development strategy and contribute to clinical sections of the Common Technical Document (CTD).

Requirements

• Must have at least three years of experience in clinical development.
• Fluent in English with native Japanese language skills.
• Must have a strong scientific background with an M.D.
• 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.

Experience Level

• At least three years of experience in clinical development

Education Level

• M.D.

About the Company

• At Merck, we are driven by curiosity and have been for the last 350 years, helping to improve the quality of life for millions of people around the world.
• We are a vibrant science and technology company with a broad portfolio in healthcare, life science and electronics.
• Our mission is to empower people, partners and patients to live a richer, fuller life.
• We are passionate about building a world where people, customers, patients and our planet can thrive together.
• We are looking for curious minds to join our team.
• We are a group of curious people with diverse backgrounds, perspectives and life experiences.
• This diversity drives excellence and innovation and strengthens our leadership in science and technology.
• We are committed to creating access and opportunities for everyone to grow and develop at their own pace.
• Join us to build an inclusive and belonging culture where everyone can make an impact and support the progress of humankind.
• Apply now to join a team dedicated to driving discovery and enhancing human progress!