[Remote] Director, Clinical Operations, Oncology

Note: The job is a remote job and is open to candidates in USA. Takeda is a patient-focused, innovation-driven company transforming the pharmaceutical industry. They are seeking a Director of Clinical Operations in Oncology to lead and direct multiple clinical programs, ensuring quality, budget adherence, and timely execution. Responsibilities • 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)) • 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 Skills • Bachelor's Degree or international equivalent required • 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 • 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 • Life Sciences preferred • Advanced degree is highly desirable • Experience in more than one therapeutic area and in line management is advantageous Benefits • Medical, dental, vision insurance • 401(k) plan and company match • Short-term and long-term disability coverage • Basic life insurance • Tuition reimbursement program • Paid volunteer time off • Company holidays • Well-being benefits • Up to 80 hours of sick time • Up to 120 hours of paid vacation Company Overview • Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs. It was founded in 1781, and is headquartered in Tokyo, Tokyo, J

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