Director, Clinical Operations, Oncology

Takeda; Boston (MA); Remote; USD 120,000 - 160,000; Full time

Job summary

Takeda seeks a Director in Clinical Operations for Oncology, reporting to the Executive Director, with responsibilities including leading clinical programs, ensuring execution aligned with business objectives, and managing oversight of strategic partners.

The ideal candidate has at least 12 years in the pharmaceutical sector and is proficient in all phases of clinical study management. This position demands strong leadership, project management skills, and a commitment to fostering an inclusive work environment.

Qualifications

• 12+ years in the pharmaceutical industry with 9+ years in clinical study management.
• Experience in Phase 2 and 3 studies and global programs.
• Expertise in global regulatory and compliance requirements for clinical research.

Responsibilities

• Lead execution of clinical programs within a Therapeutic Area Unit.
• Accountable for clinical program execution focusing on quality and budget.
• Oversee program budget planning and external spending.

Skills

Oncology experience

Leadership

Project/program management

Excellent teamwork

Problem-solving skills

Education

Bachelor’s Degree in Life Sciences

Advanced degree

Job description

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 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.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.