Director, Clinical Operations, Oncology

Role Summary

Director, Clinical Operations, Oncology based remotely reporting to the Executive Director, Clinical Operations, Oncology. This role leads the execution of clinical programs within a Therapeutic Area Unit and provides Clinical Operations leadership to drive quality, timelines, and budget adherence for large, complex programs in oncology.

Responsibilities

• Lead and direct the execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU).
• Provide line management and expert counsel for issue resolution across programs as needed.
• Provide Clinical Operations leadership under the direction of the Senior Director, Clinical Operations.
• Accountable for the overall execution of assigned clinical program(s) with focus on quality, budget, and timelines.
• Oversee Strategic Partners and other vendors to meet ICH-GCP commitments and Takeda’s business objectives.
• Manage large, complex, high-risk programs or suites of programs requiring multi-functional leadership to achieve goals.

Qualifications

• Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.
• 12 or more years’ experience in the 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 with innovative operations approaches.
• Expertise in global regulatory and compliance requirements for clinical research (e.g., US CFR, EU CTD, ICH GCP); 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). Ability to influence without authority.
• Entrepreneurial and innovative; willing to drive change; comfortable with ambiguity; promote knowledge sharing.

Education

• Bachelor’s Degree or international equivalent in Life Sciences; advanced degree highly desirable.
• At least 12 years in the pharmaceutical industry with 9+ years in clinical study management; oncology experience required.