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Job Description

Are you looking for a patient-focused company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as the Executive Director of Clinical Operations reporting to the Head of Global Clinical Development Operations.

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 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.

The Executive Director of Clinical Operations will act as a role model for Takeda’s values and be responsible for leading and participating in initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality and/or other business objectives. This individual will also be responsible for functional leadership in global clinical operations, including both direct line management (hiring, training, staff assignments, coaching, mentoring, and performance management) and indirect management of global clinical operations staff in a matrix environment. 

Objectives:

• Serve as the Global Clinical Development Operations leader within the assigned therapeutic area/business unit; establish and maintain collaborative relationships with cross-functional stakeholders and peers.
• Represent GCDO in all TA-specific forums, review boards and meetings; provide leadership/functional input into all study and program-related documentation, including the Asset Strategy, Clinical Development Plan, Protocol, etc.
• Responsible for clinical operations strategy, including the successful execution and management of global clinical programs in assigned therapeutic area(s) or business units, in support of the Clinical Development Plan (CDP).
• Responsible for financial planning/forecasting and budget management for all studies/programs within the assigned therapeutic area(s) or business units; responsible for administrative budget oversight for direct and indirect reports.
• Establish and maintain effective relationships with strategic partners and vendors; serve as primary point of contact at the therapeutic area/business unit. Ensure transparency of risks, mitigation plans and escalations with cross-functional leaders within the therapeutic area (including TAU leadership).
• Support the development of consistent Clinical Operations processes and ensuring the implementation of a unified approach across therapeutic areas.
• Initiate, develop, lead and/or participate in global initiatives representing Clinical Operations, in support of Takeda R&D objectives.

Accountabilities:

• Collaborate with global functional heads and TA leadership to define operational strategy for clinical programs, including risk management and contingency planning for clinical programs and clinical studies.  Accountable for on-time, high-quality and on-budget delivery of clinical trials within the assigned therapeutic area/business unit.
• Chair the Operational Strategy Review meetings and ensure implementation of aligned operational strategy for all studies within the therapeutic area(s)/business unit. 
• In collaboration with Study Management leadership, assess resource needs within the assigned therapeutic area/business unit; effectively manage optimal deployment of resources.
• Ensure clinical operations deliverables and work product are compliant with global regulatory and compliance requirements for clinical research, including but not limited to FDA Code of Federal Regulations, EUCTR, ICH GCP and local country requirements.
• Responsible for oversight of clinical budget planning/forecasting and management for assigned therapeutic area. 
• Ensure compliance with regulatory requirements, industry standards, and internal policies throughout the clinical trial lifecycle.
• Oversee, review and approve operational due diligence for new compounds/alliances (both early and late stage); partner with TAU/BU representatives and the Centralized Due Diligence function to ensure delivery of appropriate assumptions, trial budgets, timelines, and enrollment models.
• Maintain current therapeutic area knowledge and continually assess impact of new and evolving information on operational strategies.
• Escalate issues related to quality, timelines and budget and provide recommendations to upper management for resolution of these issues.
• Support all CRO and vendor partnerships by participating in strategic vendor governance, including risk mitigation and identification/resolution of performance issues.
• When necessary, communicate risks and escalate issues related to quality, timelines and budget; provide recommendations and solutions to TAU leadership to support resolution of issues.
• Lead and/or participate in initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality and/or other business objectives.
• Responsible for functional leadership in global clinical operations, including both direct line management (hiring, training, staff assignments, coaching, mentoring, and performance management) and indirect management of global clinical operations staff in a matrix environment.  
• Act as a role model for Takeda´s values.

Competencies:

• Deep oncology experience through Phases I-IV.
• Managing large complex global studies.
• Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to FDA Code of Federal Regulations, EUCTR, ICH GCP and local country requirements. Global/International experience required, including ability to manage intercultural regionally based teams and fluent business English skills (oral and written).
• Experience in successful change management (strategy, initiation, development and implementation of important, organization wide changes).
• Previous line management or direct management of team members.

             Education & Experience:

• Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.
• 15+ years’ experience in the pharmaceutical industry and/or clinical research organization, including 12+ years clinical study/program management, including at least 6 years of line management experience.

Ability to travel domestically and internationally up to 25%, travel reimbursed

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy

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:

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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Job Exempt