Director, Clinical Operations, Oncology
Listed on 2025-12-26
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Management
Healthcare Management -
Healthcare
Healthcare Management
Director, Clinical Operations, Oncology – Takeda
Remote position based in Massachusetts (virtual).
Base Pay Range$/yr – $/yr
OverviewTakeda is a patient‑focused, innovation‑driven pharmaceutical company that transforms the industry through R&D‑driven market leadership. This role reports to the Executive Director, Clinical Operations, Oncology and requires a seasoned clinical operations leader to guide the execution of oncology programs across a Therapeutic Area Unit.
Key Responsibilities- Lead and direct the execution of multiple clinical programs within a Therapeutic Area Unit (TAU).
- Provide line management and expert counsel for issue resolution, including programs assigned to other staff.
- Deliver Clinical Operations leadership under the direction of the Senior Director, Clinical Operations.
- Ensure overall execution of assigned clinical program(s) with focus on quality, budget, and timelines.
- Oversee Strategic Partners and other vendors to meet Takeda’s obligations described in ICH‑GCP and business objectives.
- Manage large, complex, high‑risk programs or a suite of programs requiring multi‑functional leadership to achieve program goals.
- Oversee COPLs as members of the Global Program Team (GPT) and/or CST, working closely with GPT Leadership to meet program objectives.
- Represent Clinical Operations for assigned programs in issue escalation and senior‑management awareness.
- Contribute to Clinical Development Plans and operational strategy supporting the Asset Strategy.
- Accountable for program budget planning and external spend, ensuring financial accuracy with Finance.
- Communicate program status, cost, and issues to senior management for timely decisions.
- Oversight of Strategic Partner/CRO/vendor selection, budgeting, contract negotiation, and performance supervision.
- Provide inspection readiness guidance to COPLs/COMs and support inspection activities.
- Collaborate with the Senior Director to secure adequate operations resources.
- Act as a role model for Takeda’s leadership behaviors and values.
- Represent and lead cross‑functional initiatives, recognized as a clinical operations expert.
- Participate in business development, in‑licensing, and alliance evaluations by providing operational due diligence.
- Bachelor’s Degree or equivalent (Life Sciences preferred); advanced degree highly desirable.
- 12+ years in the pharmaceutical industry, including 9+ years in clinical study management.
- Experience with early phase, Phase 2, and Phase 3 studies and global/international programs.
- Oncology experience required.
- Experience across multiple therapeutic areas and line management advantageous.
- Expertise in global regulatory and compliance requirements (US CFR, EU CTD, ICH GCP); local country requirement awareness required.
- Supervisory and matrix leadership experience.
- Excellent teamwork, organizational, interpersonal, and problem‑solving skills.
- Fluent business English (oral and written); ability to influence without authority.
- Entrepreneurial mindset, willingness to take measured risks, think outside the box, challenge status quo, and support continual improvement.
Employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision, 401(k) with match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, holidays, well‑being benefits, sick time, and paid vacation.
EEO StatementTakeda 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.
OtherInformation
Position type:
Full‑time, employee, regular. Job Exempt:
Yes.
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