Director, Clinical Operations

Bristol Myers SquibbOtemachi-JPonsiteSalary not postedView the original posting at Bristol Myers Squibb ↗

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. 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. Duties/Responsibilities Key Responsibilities 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

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