Director, Clinical Operations, Oncology

Role Summary

Director, Clinical Operations, Oncology, based remotely and reporting to the Executive Director, Clinical Operations, Oncology. Lead and direct the execution of multiple clinical programs within a Therapeutic Area Unit, providing Clinical Operations leadership and ensuring quality, budget, and timelines. Oversee strategic partners and vendors to meet ICH-GCP and Takeda objectives, with a focus on oncology programs and cross-functional collaboration.

Responsibilities

• Lead and direct the execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU).
• 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.
• Oversee Strategic Partners and other vendors to meet Takeda’s obligations described in ICH-GCP and business objectives.
• Manage programs that are large, complex, high risk and/or of business importance, including programs with multiple indications and CSTs.
• Oversee COPLs assigned to represent Clinical Operations as members of the Global Program Team and CSTs, ensuring program objectives are met.
• Represent Clinical Operations in issue escalation/awareness with senior management and governance committees.
• Contribute to the Clinical Development Plan and operational strategy in support of Asset Strategy.
• Accountable for program budget planning and external spend, ensuring financial accuracy in collaboration with Global Program Management and Finance.
• Communicate program status, cost, and issues to inform timely senior management decisions.
• Oversee selection, budgeting, and contract negotiation with Strategic Partners/CROs/vendors, ensuring performance and managing operational risk.
• Ensure inspection readiness and provide guidance to COPLs/COMs for inspection activities.
• Collaborate with the Senior Director, Clinical Operations to allocate adequate resources to programs.
• Demonstrate Takeda leadership behaviors and act as a role model for Takeda’s values.
• Be recognized as a clinical operations expert and lead cross-functional initiatives; may participate in BD/in-licensing/alliances due diligence.

Qualifications

• Bachelor’s Degree or international equivalent required; Life Sciences preferred. Advanced degree highly desirable.
• 12+ years’ experience in the pharmaceutical industry, including 9+ years in clinical study management.
• Experience in early-phase or Phase 2/3 studies and global/international programs.
• Oncology experience is required.
• Experience in more than one therapeutic area and in line management is advantageous; demonstrated excellence in leadership and project/program management.
• Expertise in global regulatory and compliance requirements for clinical research (US CFR, EU CTD, ICH GCP) and awareness of local country requirements.
• Supervisory experience; demonstrated excellence in project/program management and matrix leadership.
• Excellent teamwork, organizational, interpersonal, and problem-solving skills.
• Fluent business English (oral and written).
• Able to influence without authority; entrepreneurial, innovative, and willing to drive change; comfortable with ambiguity.
• Support a culture of continual improvement and knowledge sharing.

Education

• 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.
• Experience in more than one therapeutic area and in line management is advantageous. Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals.
• Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
• Supervisory experience.
• Demonstrated excellence in project/program management and matrix leadership.
• Excellent teamwork, organizational, interpersonal, and problem-solving skills.
• Fluent business English (oral and written).
• Able to influence without authority.
• Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo.
• Pragmatic and willing to drive and support change.
• Is comfortable with ambiguity.
• Support a culture of continual improvement and innovation; promote knowledge sharing.