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東京都の臨床開発・薬事の求人158件応募資格・募集要項・仕事内容を見る
Senior Manager, Senior Japan Clinical Lead
- 給与
- 記載なし
- 勤務地
- 東京都
- 休日
- 記載なし
- 雇用形態
- 記載なし
どんな仕事かAIによる生成
The Japan Clinical Lead serves as the clinical point of accountability for the Japan Development Team and is responsible for the overall Japan clinical development plan for assets in one or more indications. The role leads planning and execution of assigned clinical trial activities, clinical strategy, study design and analysis, and communication with external stakeholders. For Japan local studies, the role fulfills the CS role defined in Global SOP.
この求人に応募
応募資格
必須
Degree Requirements
- A minimum of 5 years of clinical development / industry experience preferred
- Expertise in the design, analysis, publication and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader).
- Adequate knowledge of pharmaceutical development process.
- Strong experience in clinical science, clinical research, or equivalent.
- Experience in a matrix team composed of multiple functional organizations.
Experience Requirements
- Ability to deliver the outcomes under the ambiguity or complexity
- Ability to partner with people at all levels of the organization
- Ability for proactive proposal building and proactive action takings without detailed instructions
- Ability to respond flexibly to the changing project/task priorities and work assignments.
- Ability to influence and negotiate without specific authority.
- Ability to take a risk and to manage it without jeopardizing quality and/or compliance
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Able to synthesize internal and external data to produce a clinical strategy
- Able to ensure that the clinical program will result in a viable registrational strategy
- Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development in Japan
- Fluent in spoken and written English for business is preferred
応募について
- If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway.
募集要項最終確認 10/21
- 職種
- 臨床開発・薬事
- 雇用形態
- 記載なし
- 役職
- Senior Manager
- 給与
- 記載なし
- 勤務地
- 東京都
- 働き方
- 記載なし
- 経験年数
- 5年以上
- 掲載日
- 2026/10/12 08:00（10日前）
- 最終確認
- 2026/10/21 15:47（1日前）
仕事内容
Position Summary / Objective
- The Japan Clinical Lead (JCL) serves as the clinical point of accountability for the Japan Development Team and is responsible for the overall Japan clinical development plan for asset(s) in one or more indication(s). JCL ensures studies are aligned with target la bel indications and designed to meet regulatory, quality, medical, and access goals to fit Japan specific requirement/situation. JCL is responsible for implementation, planning, and execution of assigned clinical trial activities, and leads communication with the external stakeholders (e.g. TLs, PI) to efficiently promote responsible clinical program. Accountable for the scientific data evaluation, interpretation and documentation for assigned project development program. For Japan local study, fulfills the CS role defined in Global SOP.
Position Responsibilities
- Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs within the asset and/or indication
- Accountable for the design, execution, and analyses of each study
- Accountable for clinical content for CSRs and regulatory documents (e.g., briefing books submission documents and regulatory responses)
- Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
- Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
- Provides clinical leadership and disease area expertise into integrated disease area strategies
- Collaborate and serve as primary liaison between external partners for scientific advice
- Serves as Primary Clinical Representative in Regulatory interactions
- Sets executional priorities and partners with CTP and operation team to support executional delivery of studies
- Accountable for top line data with support of CTP and Statisticians
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
- Evaluate innovative trial designs (collaboration with Japan CTP) • Ensure global clinical study protocol is applicable to local medical practice (manage local protocol amendment, if needed)
- Proactively identifies potential study level risks and drives the execution of mitigation strategies
- Serve as CS in Japan local studies
- o Responsible for implementation, planning, and execution of assigned clinical trial activities
- o Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision
- o Co-Leads study team meetings in partnership with Global Trial Manager; and collaborate with cross functional study team members
- o Plan and lead the implementation all study startup/conduct/close-out activities as applicable (collaboration with GTM)
- o Protocol and ICF development process; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Scientific Writing)
- o Site-facing activities such as training and serving as primary contact for clinical questions
- o Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review (collaboration with DM)
- o Clinical data trend identification; provide trends and escalate questions to Japan CTP
- o Develop clinical narrative plan; review clinical narratives
- o Provision of information required by Global Trial Manager for development of trial budget, CRO scope of work, etc.
- o Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
- Demonstrate leadership as an active member of cross functional teams, task forces, or local and global initiatives
- Effectively influence team and collaborate with senior stakeholders, address complex problems and challenges with positive outlook, able to deliver results with high level professionalism
- Coach the CL in the Clinical Lead work for development of products in Japan from study planning to JNDA filing and thereafter
この求人は、ブリストル・マイヤーズ スクイブ株式会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
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職種と勤務地が似ている求人東京都の臨床開発・薬事 158件
- ビジネスオペレーションスペシャリスト(製薬領域）
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- 臨床開発QC
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- CRC（治験コーディネーター）
- 東京モニター（未経験の方）
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