Associate Director, Clinical Study Management

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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.

• 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 performance, key risks, quality concerns, and mitigation plans, influencing decision-making within study, program, and governance forums.  
• Establish and maintain effective governance and oversight of CROs, strategic partners, and vendors, driving performance, accountability, compliance, and continuous improvement throughout the study lifecycle.  
• Serve as a subject matter expert in clinical trial execution, contributing to the development and implementation of operational best practices, process improvements, and functional standards that enhance study delivery across the organization.  
• As direct line manager, lead the coaching, and development of Clinical Study Associate levels, and other Clinical Operations staff; building organizational capability through talent development, succession planning, performance management, and mentorship while fostering a high-performing, engaged, and inclusive culture that supports delivery of current and future clinical trials.  
• Champion a culture of quality, compliance, and inspection readiness, providing leadership during audits, inspections, and regulatory interactions and ensuring robust risk-based oversight throughout study execution. 

Education: 

• BS/BA required, preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience  
• 8+ years’ experience in pharmaceutical industry and/or clinical research organization, including 5+ years clinical study management.  Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs.  Experience in more than one therapeutic area is advantageous.  
• Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements. 

Competencies: 

• Proven track record in successfully managing high risk / high complexity clinical studies, with ability to operate independently with high degree of ownership and accountability, driving collaboration, agility, and results-focused execution across the Study Execution Team (SET). 
• Applies extensive and deep expertise in global clinical research regulations and compliance requirements, including ICH-GCP, US CFR, EU CTR, and relevant local regulations, to shape compliance approach, ensure sustained inspection readiness, aligning execution with program and registration priorities. 
• Proven track record in leading end-to-end operational management, operating autonomously across highly complex work; making and shaping decisions with strategic purpose and strong understanding of downstream program implications; addresses ambiguity and risk proactively; shapes recommendations and influences higher-level decisions before issues become broader program risks. 
• Fluent in written and spoken business English. 
• Ability to travel approximately 5-20%, including domestic and international travel to Takeda sites, external partners, and study-related meetings. 

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.

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