Vice President, Head of Study Management

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Job Description

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers and work towards for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

GOALS:

• Provide strategic leadership and oversight for the Global Clinical Operations Study Management function including but not limited to:
  • Overall Study Management across all therapeutic areas.
  • Dedicated group accountable for Early Clinical Operations.
  • Implementation and management of a flexible resourcing model.
  • Training and upskilling of the COMs and CTAs.
  • Site training and elevating how Takeda shows up in the external investigator community.
• Ensure successful planning, execution, and completion of clinical trials across all therapeutic areas and regions.
• Drive operational excellence, efficiency, and quality in clinical trial management.
• Foster a culture of collaboration, innovation, and continuous improvement within the Study Management team and with cross-functional teams to ensure seamless execution of clinical trials.

ACCOUNTABILITIES:

• Lead and manage a team of Clinical Operations Managers and Clinical Trial Associates across all therapeutic areas, including establishing a vision and setting direction for the function.
• Drive the upskilling of all resources and accountable for implementing new ways of working, including embedding data and digital.
• Provide guidance and oversight to ensure the resourcing, planning, execution, and completion of clinical trials is aligned with the program and therapeutic area strategy.
• Partner with relevant functions to operationalize a training strategy aimed at increasing capabilities and driving standardization across clinical trials.
• Ensure compliance with regulatory requirements, industry standards, and internal policies throughout the clinical trial lifecycle.
• Collaborate with cross-functional teams, including Clinical Site Start-up and Engagement, Data Management, Medical Affairs, and Regulatory Affairs, to ensure seamless execution of clinical trials.
• Collaborate with other Global Clinical Development Operations leaders to ensure study timelines, budgets, and resources are sufficient to ensure successful trial completion.
• Monitor and mitigate risks and issues related to study management, escalating as necessary.
• Build and strengthen new capabilities (e.g., site management and training) to support Takeda as the sponsor of choice for our investigative sites.
• Foster strong relationships with external vendors, CROs, and other partners involved in clinical trial execution.
• Drive continuous improvement initiatives to enhance operational efficiency and quality in study management, including adoption of available technology.
• Stay updated on industry trends, regulations, and advancements in clinical trial management practices.
• Provide leadership and guidance to the Study Management team, including performance management, talent development, and succession planning.

EDUCATION & EXPERIENCE:

• Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.
• 15+ years of applicable clinical development and operations experience, ideally with at least 5 years in a global leadership role .
• Global/international experience required, including ability to collaborate with colleagues and staff in other locations.
• Proven track record of leading a training strategy and driving standardization.
• Operational experience in pharmaceutical drug development with significant direct exposure to clinical development across multiple therapeutic areas.
• Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Experience in managing teams through transformational change.
• High level of health care business acumen with a comprehensive understanding of the pharmaceutical industry.

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:

U.S. Base Salary Range:

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.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

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