Director, Clinical Operations, Oncology

Role Overview

Join us as a Director, Clinical Operations, Oncology based remotely reporting to the Executive Director, Clinical Operations, Oncology.
Goals
• 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, including programs assigned to other staff, when required.
• 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.
• The assigned clinical program(s) will be large, complex, high risk and/or of business importance to Takeda or potentially a suite of programs, requiring multi‑functional leadership experience and skills to achieve program goals. If a single program is assigned, the program will typically be significant in scope (e.g., multiple independent indications with individual Clinical Sub Teams (CSTs)).
Accountabilities
• Oversee COPLs assigned to represent Clinical Operations as members of the Global Program Team (GPT) and/or CST, working closely with GPT Leadership to ensure program objectives are met.
• Represent Clinical Operations for assigned program(s) in issue escalation/awareness with senior management, e.g. functional or regional executive staff, PRC, alliance governance committees.
• Contribute to the Clinical Development Plan(s) and associated operational strategy, in support of the Asset Strategy.
• Accountable for program budget planning and external spend related to program execution and works closely with Global Program Management, and Finance to ensure financial accuracy.
• Ensures communication of program status, cost and issues to inform timely decision‑making by senior management.
• Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees; accountable for operational risk management strategy in collaboration with Strategic Partners.
• Accountable for inspection readiness and provides appropriate guidance to COPLs/COMs in support of inspection activities.
• Collaborates with and is responsible to the Senior Director, Clinical Operations to ensure adequate clinical operations resources are assigned to program(s).
• Demonstrate advanced Takeda Leadership Behaviors and act as a role model for Takeda´s values.
• Recognized as a clinical operations expert by other functions and ability to represent and lead cross functional initiatives.
• May participate in Business Development/in‑licensing/alliances evaluations by providing operational due diligence.
Education and Experience
• 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…