Director, Clinical Operations, Oncology
Takeda
August 30, 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; responsible for line management and expert counsel for issue resolution.
- Accountable for overall execution of assigned clinical program(s) focused on quality, budget, and timelines.
- Oversee Strategic Partners and other vendors to meet ICH-GCP and business objectives.
- Oversee COPLs representing Clinical Operations in Global Program Team (GPT) and/or CST; ensure program objectives are met.
- Escalate program issues/awareness to senior management; contribute to operational strategy and Clinical Development Plan(s).
- Own program budget planning and external spend accuracy; communicate program status, costs, and issues.
- Lead vendor/CRO selection, contract negotiation, performance supervision, governance escalation, and operational risk management.
- Support inspection readiness and guide COPLs/COMs.
- Ensure adequate clinical operations resourcing with Senior Director, Clinical Operations.
- Model Takeda Leadership Behaviors and values; represent and lead cross-functional initiatives.
- May support business development/in-licensing/alliances with operational due diligence.
Education & Experience (Required):
- Bachelor’s degree (Life Sciences preferred); advanced degree desirable.
- 12+ years pharmaceutical industry experience, including 9+ years clinical study management.
- Early phase or Phase 2/3; global/international programs; Oncology experience.
Skills/Qualifications:
- Global regulatory/compliance expertise (US CFR, EU CTD, ICH-GCP) and awareness of local requirements.
- Supervisory experience; strong project/program management and matrix leadership.
- Leadership, teamwork, organization, problem-solving; fluent business English.
- Ability to influence without authority; entrepreneurial, change-driven, comfortable with ambiguity.
Application:
- Apply 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; responsible for line management and expert counsel for issue resolution.
- Accountable for overall execution of assigned clinical program(s) focused on quality, budget, and timelines.
- Oversee Strategic Partners and other vendors to meet ICH-GCP and business objectives.
- Oversee COPLs representing Clinical Operations in Global Program Team (GPT) and/or CST; ensure program objectives are met.
- Escalate program issues/awareness to senior management; contribute to operational strategy and Clinical Development Plan(s).
- Own program budget planning and external spend accuracy; communicate program status, costs, and issues.
- Lead vendor/CRO selection, contract negotiation, performance supervision, governance escalation, and operational risk management.
- Support inspection readiness and guide COPLs/COMs.
- Ensure adequate clinical operations resourcing with Senior Director, Clinical Operations.
- Model Takeda Leadership Behaviors and values; represent and lead cross-functional initiatives.
- May support business development/in-licensing/alliances with operational due diligence.
Education & Experience (Required):
- Bachelor’s degree (Life Sciences preferred); advanced degree desirable.
- 12+ years pharmaceutical industry experience, including 9+ years clinical study management.
- Early phase or Phase 2/3; global/international programs; Oncology experience.
Skills/Qualifications:
- Global regulatory/compliance expertise (US CFR, EU CTD, ICH-GCP) and awareness of local requirements.
- Supervisory experience; strong project/program management and matrix leadership.
- Leadership, teamwork, organization, problem-solving; fluent business English.
- Ability to influence without authority; entrepreneurial, change-driven, comfortable with ambiguity.
Application:
- Apply via the “Apply” button.