Director, Clinical Operations – Oncology
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Job Description
Director, Clinical Operations overseeing multiple clinical programs in Oncology at Takeda. Leading execution, quality, budget, and compliance for clinical study management with extensive industry experience.
Responsibilities:
- Lead and direct the execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU).
- Responsible for line management and provides expert counsel for issue resolution.
- Provide Clinical Operations leadership under the direction of the Senior Director, Clinical Operations.
- Accountable for the overall execution of the assigned clinical program(s) with focus on quality, budget and timelines.
- Accountable for the oversight of Strategic Partners and other vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.
- Ensure communication of program status, cost and issues to inform timely decision-making by senior management.
- Accountable for inspection readiness and provides appropriate guidance to COPLs/COMs in support of inspection activities.
Requirements:
- Bachelor’s Degree or international equivalent required, Life Sciences preferred.
- Advanced degree is highly desirable.
- 12 or more years’ experience in pharmaceutical industry, including 9 or more years in clinical study management.
- Experience must include early phase experience or Phase 2 and 3 studies and global/international programs.
- Oncology experience is required.
- Supervisory experience.
- Demonstrated excellence in project/program management, including innovative operations approaches to achieving program goals.
- Expertise in global regulatory and compliance requirements for clinical research.
- Fluent business English (oral and written).
Benefits:
- U.S. based employees may be eligible for short-term and/or long-term incentives.
- U.S. based employees may be eligible to participate in medical, dental, vision insurance.
- 401(k) plan and company match.
- Short-term and long-term disability coverage.
- Basic life insurance.
- Tuition reimbursement program.
- Paid volunteer time off.
- Company holidays.
- Well-being benefits.
- Up to 80 hours of sick time.
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