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Medical Director_Clinical Development/ Biopharma (Tokyo)

 

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

Title: Medical Director

Location: Tokyo

Report to: Head of GCD Japan

Direct reports: 0 (Single contributor)

 

KEY ACCOUNTABILITIES

Act as a medical responsible:

Ÿ   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.

Ÿ   Review and sign off all clinical documents related to the clinical studies (e.g. study protocols and study reports) within area of responsibility

Ÿ   Conduct medical monitoring for responsible project/study, if applicable

Ÿ   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

Ÿ   Support the review, analysis and interpretation of study data

Ÿ   Support communication of study results as assigned

 

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

Ÿ   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

Ÿ   Develop Biomarker strategy in collaboration with the global biomarker team

Ÿ   Propose translational studies in collaboration with the global clinical lead and the biomarker team and facilitate the study.

Ÿ   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)

Ÿ   Liaise with (principal) investigators, health authorities, IEC/IRB, consultants, opinion/thought leaders and academic institutions within area of responsibility to deliver on key accountabilities.

Ÿ   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

Ÿ   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

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

Ÿ   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

Ÿ   Provide medical input to regulatory development strategy and contribute to clinical sections of the

Ÿ   Common Technical Document (CTD)

 

CANDIDATE PROFILE

MD holder with enough clinical experiences MUST to have.

Advanced knowledge in medical/scientific area (oncology, neurology, or immunology) required.

Native level in Japanese and fluent in English

≥ 3 years of involvement in clinical research or drug development in an industry in Phases I to III.

Strong leadership competencies and influencing skills.

Effective oral and written communication skills.

Strong negotiation and diplomatic skills, experience with health authorities desirable.

Considerable organizational awareness, including significant experience working cross-functionally and in global teams.

Medical/scientific and operational knowledge in oncology, neurology and/or immunology.

 

Recruting Contact: Fang LIU

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

Job Requisition ID:  229814
Location:  Tokyo
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. 

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by the Company. The Company uses the definition of “fully vaccinated” assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

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