Study Implementation Lead
Takeda
Summary
In this Associate Director level role, you will help lead the planning, implementation, execution, and delivery of clinical studies and evidence generation activities across a diverse portfolio of research programs. You will play a key role in ensuring studies are operationally feasible, compliant, and delivered to agreed quality, timeline, budget, and performance expectations. Working in a matrixed environment, you will collaborate closely with cross-functional teams and external partners to support successful study execution and continuous improvement.
Job description
About the Role
In this Associate Director level role, you will help lead the planning, implementation, execution, and delivery of clinical studies and evidence generation activities across a diverse portfolio of research programs. You will play a key role in ensuring studies are operationally feasible, compliant, and delivered to agreed quality, timeline, budget, and performance expectations. Working in a matrixed environment, you will collaborate closely with cross-functional teams and external partners to support successful study execution and continuous improvement.
How You Will Contribute
- Lead study implementation activities for assigned studies and programs across the evidence generation portfolio.
- Develop and manage study plans including timelines, budgets, resource forecasts, enrollment strategies, and operational risk mitigation plans.
- Oversee study execution and reporting through start-up, activation, conduct, close-out, and reporting activities aligned with approved plans.
- Monitor study performance and address risks by tracking quality, timelines, budgets, milestones, resources, and operational indicators.
- Manage vendors and external partners to ensure delivery against study objectives, contractual commitments, quality expectations, and timelines.
- Ensure compliance with study requirements by maintaining adherence to protocols, regulations, quality standards, and standard operating procedures.
- Lead cross-functional teams and partnerships to enable effective study delivery, issue resolution, and operational decision-making.
- Drive process improvement and innovation through implementation excellence, standardization, coaching, and the responsible adoption of digital and artificial intelligence-enabled solutions.
Qualifications
- Advanced degree in a scientific, clinical, epidemiologic, quantitative, public health, or related discipline.
- 8+ years of experience in clinical development, evidence generation, clinical operations, clinical research, or related environments involving interventional and non-interventional studies.
- Strong experience in clinical operations, real-world evidence generation, or related clinical research environments.
- Demonstrated experience managing clinical study implementation, including start-up, execution, close-out, and reporting activities.
- Working knowledge of good clinical practice, applicable regulatory requirements, quality standards, and standard operating procedure-driven clinical research practices.
- Experience developing and managing study plans, timelines, budgets, forecasts, resources, and operational risk mitigation strategies.
- Experience overseeing vendors, contracts, and external provider performance.
- Strong project management, stakeholder management, negotiation, communication, problem-solving, organizational, and team leadership skills, including experience using clinical study systems, digital tools, analytics platforms, and artificial intelligence-enabled capabilities in a regulated environment.
Requirements
- Advanced degree in a scientific, clinical, epidemiologic, quantitative, public health, or related discipline
- 8+ years of experience in clinical development, evidence generation, clinical operations, clinical research, or related environments involving interventional and non-interventional studies
- Strong experience in clinical operations, real-world evidence generation, or related clinical research environments
- Demonstrated experience managing clinical study implementation, including start-up, execution, close-out, and reporting activities
- Working knowledge of good clinical practice, applicable regulatory requirements, quality standards, and standard operating procedure-driven clinical research practices
- Experience developing and managing study plans, timelines, budgets, forecasts, resources, and operational risk mitigation strategies
- Experience overseeing vendors, contracts, and external provider performance
- Strong project management, stakeholder management, negotiation, communication, problem-solving, organizational, and team leadership skills
- Experience using clinical study systems, digital tools, analytics platforms, and artificial intelligence-enabled capabilities in a regulated environment
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.