Medical Director - 製薬会社

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

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[Position] Medical Director
[Location] 東京都
[Salary] 15〜20 million JPY ※Experiences and skills will be considered
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[Company Description]
外資系製薬会社

[Responsibilities]
KEY ACCOUNTABILITIES
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

STRATEGIC IMPACT
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)

[Requirements]

  • 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.


Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Reference: JO-2110-464603
#LI-REMOTE
Seniority Level: Director
Job Function: Health Care Provider