Head of Clinical Development Center Japan

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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.

JOB DESCRIPTION

Position Title : Head of Clinical Development Center Japan   

Reporting to : Head of R&D Japan

Department: Healthcare Global Research & Development-Strategy, Portfolio, Hubs-R&D Japan

Location: Tokyo/Japan

Direct Reports: 3-4 (Medical directors and Clinical scientists)

Position Summary

The Head of Clinical Development Center (CDC) Japan will play a key role, in driving the global development strategy and execution of early to late-stage development programs across the company portfolio to bring innovative medicines to patients in Japan. This critical role is to provide and ensure ethical and scientific contributions to product development activities in Japan. The position is also expected to make a major contribution as a member of R&D LT to deliver on “Biopharma Japan 5 Year Strategy” to ensure its growth as a specialty care innovator in Japan through working collaboratively with other functions.

Key Accountabilities

Management of CDC organization:

• Lead and manage CDC Team in close collaboration with the respective global functional leaders
• Foster People engagement, cultivate a positive working environment, and manage infrastructures
• Handle resource allocation, people management, regional/country-based trainings
• Be accountable for overseeing and supervising the following clinical representative roles in global project and regional teams:
  • Provide medical and 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 the 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 and communicate study results as assigned
  • Propose clinical development strategies in Japan for assigned indication(s)/product(s) to establish safety, efficacy and support registration in the shortest possible time in Japan, considering the local medical environment
  • Develop a 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)
  • Engage and 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
• Explore inorganic opportunities for innovative research, early & late-phase development assets and LCMs in Japan by providing medical-scientific expertise for evaluation of in/out licensing opportunities as appropriate.

Leadership role in Biopharma Japan:

• Represent CDC as a key member of R&D Japan Leadership Team and contribute to the senior management team activities beyond R&D to ensure sustainable growth of Biopharma in Japanese business environment.
• Establish the scheme of early engagement & active involvement in our global R&D strategy from Japan

Candidate’s Profile:

Education:

• Medicine Doctor (MD) degree (Must to have)
• Board certification, training, or relevant experience in Oncology (preferably)

Work Experience:

• Minimum experience of 10-15 years of drug development in pharmaceutical companies or the biotechnology industry, with above 5 years of demonstrated management experience
• Deep knowledge and solid experience of clinical drug development

Job Specific Competencies & Skills:

• The ability to work effectively in a high-pressure, fast-paced, and global work environment.
• Requirement to be willing and capable of working collaboratively within project, program, and functional teams, as well as with other functions beyond the teams.
• Strong oral and written communication skills, including the ability to make presentations to external parties.
• Ability to foresee and manage risks in a drug development and product maintenance processes.
• High proficiency in English and native fluency in Japanese.

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!
 
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