Takeda · 5 days ago
Director, Clinical Operations, Oncology
United States
Full-time
Remote
Director/Executive
$174K/yr - $274K/yr
12+ years expTakeda 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.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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
Qualification
Required
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
Preferred
Life Sciences preferred
Advanced degree is highly desirable
Experience in more than one therapeutic area and in line management is advantageous
Benefits
U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-14
Pharmaceutical Technology
2026-01-11
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