Study Implementation Lead

Takeda Pharmaceutical Co.; Kendall Square (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking an Associate Director to lead planning, implementation, and delivery of clinical studies within a diverse evidence generation portfolio at Takeda's USA MA Cambridge Kendall Square site.

The role emphasizes operational feasibility, quality, timelines, budgets, and cross-functional collaboration to drive high-impact study delivery. You will advance operational excellence by leveraging digital tools and AI-enabled capabilities while ensuring compliance, data

Qualifications

• Advanced degree in a scientific, clinical, epidemiologic, quantitative, public health, or related discipline.
• 8+ years of experience in clinical development, evidence generation, or related environments.
• Strong experience in clinical operations and real-world evidence generation.
• Experience managing start-up, execution, close-out, and reporting of clinical studies.
• Working knowledge of good clinical practice and regulatory requirements.
• Experience developing and managing study plans, timelines, budgets, forecasts, and resources.
• Experience overseeing vendors and external provider performance.
• Strong project management and cross-functional leadership in regulated environments with AI-enabled capabilities.

Responsibilities

• 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 risk mitigation.
• Oversee study execution and reporting from start-up to close-out.
• Monitor study performance and address risks by tracking quality, timelines, budgets, milestones, resources, and operational indicators.
• Manage vendors and external partners to meet study objectives, quality expectations, and timelines.
• Ensure compliance with study requirements by maintaining adherence to protocols, regulations, quality standards, and SOPs.
• Lead cross-functional teams to enable effective study delivery and decision-making.
• Drive process improvement and adoption of AI-enabled capabilities.

Skills

Project management

Stakeholder management

Leadership

Communication

Problem solving

Regulatory knowledge

Education

Advanced degree in science/clinical/public health

Tools

Clinical study systems

Digital analytics tools

AI-enabled capabilities

Data privacy/compliance tools

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. Your work will contribute to efficient study delivery and high-quality evidence generation while supporting broader organizational objectives. You will also be part of a team that advances operational excellence through the appropriate use of digital and artificial intelligence-enabled capabilities that strengthen planning, oversight, analytics, efficiency, and evidence-based decision-making while maintaining compliance, data privacy, and quality standards.

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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location: USA - MA - Cambridge - Kendall Square - 500

U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Cambridge - Kendall Square - 500

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.