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？
患者さんのためにひとつになって団結し、生命の誕生、QOLの向上、命をつなぐサポートをすることか、ヘルスケアにおける私たちの目的です。私たちは、腫瘍学、神経学、不妊治療などの疾患領域において、医薬品、インテリジェント装置、革新的技術を開発します。私たちのチームは、人生のすべてのステージで患者さんを助けるために、情熱と執拗な好奇心を持って6大陸全体で協力して働いています。ヘルスケアチームに入ることは、多様的で包含的、そして柔軟な職場文化の一部となることです。世界中で個人的な能力開発とキャリアアップの素晴らしいチャンスが待ち受けています。
Clinical Scientist
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
- Minimum of 3 years of experience in pharmaceutical companies, preferably with experience in clinical development.
- 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.
- 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
私たちが提供するもの：私たちは、さまざまな背景、視点、人生経験を持つ好奇心旺盛な人々で構成されるグループです。この多様性が卓越性と革新を促進し、科学と技術のリーダーシップを強化すると信じています。私たちは、すべての人が自分のペースで成長し発展するためのアクセスと機会を創出することにコミットしています。何百万もの人々に影響を与え、誰もが人類の進歩を支持できるようにする包括性と帰属感のある文化を築くために私たちに参加してください！
今すぐ応募して、発見を促し、人類の発展を高めることに専念するチームの一員になりましょう！
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