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Director, Clinical Operations, Oncology

Takeda
August 07, 2026
Remote
United States
$177,000 - $278,080 USD yearly
Clinical Research and Development
Director, Clinical Operations, Oncology (Remote)
Reports to: Executive Director, Clinical Operations, Oncology

GOALS
- Lead and direct execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU).
- Provide line management and expert counsel for issue resolution.
- Provide Clinical Operations leadership under the Senior Director, Clinical Operations.
- Ensure overall program execution (quality, budget, timelines).
- Oversee Strategic Partners and vendors to meet ICH-GCP and business objectives.

ACCOUNTABILITIES
- Oversee COPLs representing Clinical Operations in Global Program Team (GPT) and/or CST.
- Escalate/raise awareness on program issues with senior management (e.g., PRC, governance committees).
- Contribute to Clinical Development Plan(s) and operational strategy supporting Asset Strategy.
- Own program budget planning and external spend accuracy with Global Program Management and Finance.
- Ensure timely communication of program status, costs, and issues.
- Oversee partner/CRO/vendor selection, budgeting, contract negotiation, supervision, issue escalation, and operational risk management.
- Ensure inspection readiness and guide COPLs/COMs.
- Collaborate with Senior Director to ensure adequate clinical operations resources.
- Act as role model for Takeda values; lead cross-functional initiatives.

EDUCATION AND EXPERIENCE / REQUIREMENTS
- Bachelor’s degree (Life Sciences preferred); advanced degree desirable.
- 12+ years pharma industry; 9+ years clinical study management.
- Early phase and/or Phase 2/3; global/international programs; oncology experience required.
- Expertise in global regulatory/compliance for clinical research (e.g., US CFR, EU CTD, ICH GCP).
- Supervisory and matrix leadership experience.

SKILLS
- Project/program management excellence; influence without authority; fluent business English.

Benefits (explicitly listed)
- U.S.-based may be eligible for medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 sick hours/year and up to 120 hours paid vacation for new hires.

Application instruction
- Apply via the β€œApply” button (employment application process begins).