Director, Clinical Operations, Oncology
Takeda
August 08, 2026
Remote
United States
$177,000 - $278,080 USD yearly
Operations
Director, Clinical Operations, Oncology (Remote)
Goals / Responsibilities:
- Lead and direct execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU).
- Provide Clinical Operations leadership and line management; counsel on issue resolution.
- Ensure overall program execution (quality, budget, timelines).
- Oversee Strategic Partners and other vendors to meet ICH-GCP and business objectives.
- Oversee COPLs representing Clinical Operations on Global Program Team (GPT) and/or CST; ensure program objectives are met.
- Escalate and communicate program issues/status/cost to senior management.
- Contribute to Clinical Development Plans and operational strategy in support of Asset Strategy.
- Own program budget planning and external spend accuracy (with Global Program Management and Finance).
- Lead partner/CRO/vendor selection, contract negotiation, performance supervision, governance participation, and operational risk management.
- Ensure inspection readiness; provide guidance to COPLs/COMs for inspection activities.
- Collaborate with Senior Director, Clinical Operations to ensure adequate clinical operations resources.
- Represent Clinical Operations in cross-functional initiatives; may support business development/in-licensing evaluations via operational due diligence.
Qualifications / Requirements:
- Bachelor’s degree (Life Sciences preferred); advanced degree highly desirable.
- 12+ years pharmaceutical industry experience, including 9+ years in clinical study management.
- Early phase or Phase 2/3 experience; global/international programs.
- Oncology experience required.
- Supervisory experience.
- Expertise in global regulatory/compliance requirements (e.g., US CFR, EU CTD, ICH-GCP) and local country requirements.
Skills (Preferred/Required):
- Demonstrated leadership, project/program management, and matrix leadership.
- Excellent teamwork, organization, interpersonal, and problem-solving skills.
- Fluent business English; ability to influence without authority.
- Entrepreneurial/innovative mindset; comfortable with ambiguity; drives continual improvement and knowledge sharing.
Application:
- Submit an application via the “Apply” button.
Goals / Responsibilities:
- Lead and direct execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU).
- Provide Clinical Operations leadership and line management; counsel on issue resolution.
- Ensure overall program execution (quality, budget, timelines).
- Oversee Strategic Partners and other vendors to meet ICH-GCP and business objectives.
- Oversee COPLs representing Clinical Operations on Global Program Team (GPT) and/or CST; ensure program objectives are met.
- Escalate and communicate program issues/status/cost to senior management.
- Contribute to Clinical Development Plans and operational strategy in support of Asset Strategy.
- Own program budget planning and external spend accuracy (with Global Program Management and Finance).
- Lead partner/CRO/vendor selection, contract negotiation, performance supervision, governance participation, and operational risk management.
- Ensure inspection readiness; provide guidance to COPLs/COMs for inspection activities.
- Collaborate with Senior Director, Clinical Operations to ensure adequate clinical operations resources.
- Represent Clinical Operations in cross-functional initiatives; may support business development/in-licensing evaluations via operational due diligence.
Qualifications / Requirements:
- Bachelor’s degree (Life Sciences preferred); advanced degree highly desirable.
- 12+ years pharmaceutical industry experience, including 9+ years in clinical study management.
- Early phase or Phase 2/3 experience; global/international programs.
- Oncology experience required.
- Supervisory experience.
- Expertise in global regulatory/compliance requirements (e.g., US CFR, EU CTD, ICH-GCP) and local country requirements.
Skills (Preferred/Required):
- Demonstrated leadership, project/program management, and matrix leadership.
- Excellent teamwork, organization, interpersonal, and problem-solving skills.
- Fluent business English; ability to influence without authority.
- Entrepreneurial/innovative mindset; comfortable with ambiguity; drives continual improvement and knowledge sharing.
Application:
- Submit an application via the “Apply” button.