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Job Description
About the Role:
As an Associate Director, Clinical Study Management, you will help lead the operational delivery of complex, global, and high-priority clinical studies from planning through closeout. In this role, you will provide independent leadership for study execution, helping align cross-functional teams, manage risks, and support timely decisions in complex situations. Your work will contribute to strong study quality, inspection readiness, and delivery against timeline and budget goals.
You will also help create a supportive environment for clinical operations talent development, while working with internal and external partners to keep study plans on track and support broader development goals.
How You Will Contribute:
Lead the cross-functional Study Execution Team (SET) for complex, global, and high-priority clinical studies, with full end-to-end accountability for study operational planning, execution, oversight, and delivery in support of the Clinical Development Plan.
Provide independent operational leadership and serve as the primary decision-maker for study execution, proactively driving planning, risk management, stakeholder alignment, and resolution of complex operational challenges to ensure delivery of study objectives within quality, timeline, and budget expectations.
Ensure inspection-ready, compliant study execution and closeout throughout the study lifecycle through robust oversight, governance, and risk-based management approaches in accordance with ICH-GCP, applicable regulations, and Takeda SOPs, while influencing operational plans and delivery across internal and external stakeholders.
Lead the development of Clinical Operations talent, including Clinical Study Associates to Clinical Study Manager levels, through structured onboarding, coaching, mentoring, performance management, and career development initiatives, ensuring a strong pipeline of skilled study management professionals and future leaders
Lead with full end-to-end accountability for the operational planning, execution, oversight, and delivery of complex, global, and high-priority clinical studies, ensuring achievement of development milestones while balancing quality, timeline, budget, and risk considerations.
Serve as the independent operational authority for assigned studies, providing direction on study execution plans, governance, and critical business decisions in complex or ambiguous situations.
Lead and influence the cross-functional Study Execution Team (SET), establishing clear accountability, fostering a high-performance culture, and driving alignment across internal and external stakeholders to achieve study objectives.
Leads with extensive operational expertise to contribute to the study design and protocol development to ensure operational feasibility, and identify innovative approaches that optimize study execution, patient recruitment, data quality, and development timelines.
Anticipate and proactively address significant operational risks, emerging issues, and cross-functional dependencies, driving timely mitigation and resolution while assessing the impact on broader program objectives.
Own the Integrated Study Timeline (IST) and critical path planning, ensuring alignment across functions and proactively managing competing priorities, resource constraints, and delivery risks.
Maintain full accountability for study budgets, forecasts, and external spend, making informed trade-off decisions and driving financial performance through proactive management of resources, risks, and opportunities.
Provide executive-level updates and recommendations on study…