Director, Clinical Operations, Oncology
Takeda
2 days ago
Remote
United States
$177,000 - $278,080 USD yearly
Operations
Director, Clinical Operations, Oncology (Remote; reporting to Executive Director, Clinical Operations, Oncology)
Responsibilities:
- Lead and direct execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU).
- Provide line management, expert counsel for issue resolution, and Clinical Operations leadership.
- Ensure overall execution of assigned program(s) with focus on quality, budget, and timelines.
- Oversee Strategic Partners and other vendors to meet ICH-GCP and business objectives.
- Oversee program execution via Global Program Team (GPT) and/or Clinical Sub Teams (CSTs) to meet objectives.
- Represent Clinical Operations for issue escalation/awareness with senior management and governance committees.
- Contribute to Clinical Development Plans 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, contract negotiation, performance supervision, and operational risk management.
- Ensure inspection readiness and guide COPLs/COMs for inspection activities.
- Collaborate with the Senior Director to ensure adequate resources for program(s).
- Act as a role model for Takeda leadership behaviors; lead cross-functional initiatives.
- May support business development/in-licensing/alliances operational due diligence.
Qualifications:
- Bachelor’s degree required (Life Sciences preferred); advanced degree highly desirable.
- 12+ years pharma experience, including 9+ years clinical study management.
- Early phase and/or Phase 2/3; experience with global/international programs.
- Oncology experience required.
- Line management experience advantageous.
Skills/Requirements:
- Global regulatory/compliance expertise (US CFR, EU CTD, ICH-GCP) and awareness of local requirements.
- Supervisory experience; strong project/program management and matrix leadership.
- Excellent teamwork, organization, interpersonal, problem-solving; influence without authority.
- Fluent business English; comfort with ambiguity; drives/pragmatic change; supports continual improvement and knowledge sharing.
Benefits (explicitly stated): Eligibility for medical, dental, vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, paid holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires; may be eligible for short-/long-term incentives.
Application instructions:
- Apply using the “Apply” button (employment application process commences; application information is processed per Privacy Notice and Terms of Use).
Responsibilities:
- Lead and direct execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU).
- Provide line management, expert counsel for issue resolution, and Clinical Operations leadership.
- Ensure overall execution of assigned program(s) with focus on quality, budget, and timelines.
- Oversee Strategic Partners and other vendors to meet ICH-GCP and business objectives.
- Oversee program execution via Global Program Team (GPT) and/or Clinical Sub Teams (CSTs) to meet objectives.
- Represent Clinical Operations for issue escalation/awareness with senior management and governance committees.
- Contribute to Clinical Development Plans 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, contract negotiation, performance supervision, and operational risk management.
- Ensure inspection readiness and guide COPLs/COMs for inspection activities.
- Collaborate with the Senior Director to ensure adequate resources for program(s).
- Act as a role model for Takeda leadership behaviors; lead cross-functional initiatives.
- May support business development/in-licensing/alliances operational due diligence.
Qualifications:
- Bachelor’s degree required (Life Sciences preferred); advanced degree highly desirable.
- 12+ years pharma experience, including 9+ years clinical study management.
- Early phase and/or Phase 2/3; experience with global/international programs.
- Oncology experience required.
- Line management experience advantageous.
Skills/Requirements:
- Global regulatory/compliance expertise (US CFR, EU CTD, ICH-GCP) and awareness of local requirements.
- Supervisory experience; strong project/program management and matrix leadership.
- Excellent teamwork, organization, interpersonal, problem-solving; influence without authority.
- Fluent business English; comfort with ambiguity; drives/pragmatic change; supports continual improvement and knowledge sharing.
Benefits (explicitly stated): Eligibility for medical, dental, vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, paid holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires; may be eligible for short-/long-term incentives.
Application instructions:
- Apply using the “Apply” button (employment application process commences; application information is processed per Privacy Notice and Terms of Use).