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臨床開発・薬事の求人335件応募資格・募集要項・仕事内容を見る
Director, Clinical Operations
- 給与
- 記載なし
- 勤務地
- 記載なし
- 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
Leads end-to-end clinical trial delivery for the assigned Therapeutic Area portfolio within RCO Japan, directing the CTM and CRA line functions as an integrated operating model. The role is accountable for portfolio strategy, resourcing, study delivery, quality and compliance, and leads partnerships with internal and external stakeholders. It also manages and develops Line Managers and supports portfolio-wide decisions and performance.
この求人に応募
応募資格
必須
- Minimum of 12 years pharmaceutical industry experience in Clinical Research including significant leadership experience in clinical trial operations.
- Demonstrated experience leading people leaders/managers (i.e., managing managers) across both trial management (CTM) and site management (CRA) disciplines, or equivalent cross-functional leadership experience.
- Significant experience in the planning, conduct and management of clinical programs (Phase I-IV).
- Prior clinical trial management and/or monitoring experience required.
- Proven track record of strategic leadership, cross-functional collaboration, and external partnership management.
- Demonstrated ability to make final decisions on portfolio-level strategy, resourcing, and risk mitigation.
- Experience with Health Authority inspections and audits.
- In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research.
- Demonstrated organizational and planning skills and independent decision-making ability.
- Strong organization and time management skills and ability to effectively manage multiple competing priorities across a multi-disciplinary portfolio.
- Outstanding interpersonal, oral and written communication skills to influence, inform or guide others; ability to build trusted partnerships with senior internal and external stakeholders.
- Good verbal and written communication skills (both in English and Japanese).
- Software that must be used independently and without assistance (Microsoft Suite, Clinical Trial Management Systems (CTMS)).
- Demonstrated ability to effectively utilize AI tools to support clinical operations work, combined with a strong learning agility and adaptability to continuously acquire and apply new AI-related skills and capabilities.
- Bachelors or Masters degree required. Field of study within life sciences or equivalent; advanced degree preferred.
- Domestic travel to clinical trial sites and international travel where required (approximately 10-20% of working time in the field).
歓迎
- Project Management certification or equivalent (preferred).
応募について
- We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match 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
- Director, Clinical OperationsRCO Japan Leadership Team
- 給与
- 記載なし
- 勤務地
- Otemachi-JP
- 働き方
- 記載なし
- 経験年数
- 12年以上
- 学歴
- 大学院修了以上
- 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
- To lead and be accountable for end-to-end delivery of the assigned Therapeutic Area (TA) portfolio within RCO Japan, by directing both the Clinical Trial Management (CTM) and Clinical Research Associate (CRA)/Site Management line functions as a single, integrated operating model.
- Ensure delivery of clinical operations effectiveness across the TA portfolio in RCO Japan, in alignment with global R&D and local business priorities and the RCO Japan Book of Work.
- Serve as a member of the RCO Japan Leadership Team, reporting to the RCO Japan Head, and contribute to RCO Japan-wide strategy, resourcing decisions, and quality culture.
Portfolio & Operational Leadership
- Own end-to-end accountability for clinical trial delivery across the assigned TA portfolio, integrating the CTM (trial management) and CRA (site management) functions into a single accountable operating model.
- Execute the assigned TA portfolio in line with the RCO Japan Book of Work, ensuring timely study start-up and that target subject recruitment numbers and database lock timelines are met.
- Direct and align CTM Line Managers and CRA Line Managers to ensure consistent resourcing, workload evaluations, and study assignments in alignment with R&D and local priorities.
- Make decisions on portfolio-level resource allocation, study prioritization, and risk mitigation strategies.
- Accountable for portfolio-level study metrics (enrollment, quality, timeline, budget) and team performance across both CTM and CRA functions.
- Approve study fee funds and payments within grant of authority for the portfolio.
- Ensure implementation of Corrective Action/Preventive Action (CAPA) and provide necessary resources/tools at the portfolio level.
Strategic Partnership & Organizational Leadership
- Serve as the senior RCO Japan representative for the assigned TA portfolio, building trusted partnerships with CD TA Head(s), GRS TA Head(s), Medical, GPV and HR to align on Japan strategy and delivery.
- Lead strategic partnerships with internal and external stakeholders to advance clinical trial innovation and operational excellence across the portfolio.
- Discuss, decide and coordinate roles & responsibilities across the CTM and CRA organizations; build and continuously improve the operating structure for the portfolio.
- Represent RCO in local affiliate leadership discussions and external forums as needed.
Compliance & Quality
- Take ultimate accountability for GCP, ICH Guidelines and local regulatory compliance across the portfolio's clinical trial delivery.
- Support Health Authority inspections, pre-inspection activities, and audit preparation for the portfolio.
- Assess and escalate significant compliance/quality risks, and build consensus on risk minimization or mitigation plans with relevant stakeholders.
- Support a GDO Quality Culture, collaborating with the GDO Global Clinical Compliance team and the GQ Clinical Trial and Safety group as needed.
Talent Management
- As a role model, ensure CTM Line Managers and CRA Line Managers fulfill their supervisory responsibilities properly, and provide them with necessary support after sharing all direct reports' responsibilities.
- Provide expert advice, coaching and skill development to Line Managers to enable them to fulfill their competency effectively.
- Manage hiring, performance management, and succession planning for Line Managers and, through them, the broader CTM/CRA organization.
- Participate in performance calibration and talent review meetings for the portfolio.
- Foster a culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability across the organization.
Stakeholder Engagement
- Collaborate with cross-functional stakeholders (local Medical, Clinical Development, RDSP, DQS, GRS, PS, Commercial, Human Resources, Legal and Compliance) to ensure integrated, portfolio-wide delivery, consistent with RCO Japan's broader matrix relationships.
- Ensure effective external partnerships with study sites, investigators, trade associations, and local health authorities (e.g., PMDA) relevant to the portfolio.
- Spend approximately 10-20% of working time in the field, visiting clinical trial sites and operational KOLs, to build and maintain strong relationships with key sites and investigators.
Digital, AI & Data-Driven Operations
- Leverage digital platforms and data analytics across the CTM and CRA functions to optimize resource allocation, monitor portfolio-level study progress, and support decision-making.
- Actively utilize AI tools and applications across the CTM and CRA functions to drive efficiency, generate insights, and enhance quality of decision-making, while championing a continuous learning mindset and adaptability to evolving AI capabilities within the organization.
Reporting Relationship
- Report to Direct Supervisor: Senior Director, Clinical Operations (RCO Japan Head).
Supervisory Responsibility
- Direct line reporting responsibility for RCO Line Manager of Clinical Trial Manager and RCO Line Manager of CRA roles within the assigned Therapeutic Area portfolio.
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