Role Summary
Director, Clinical Operations, Oncology based remotely reporting to the Executive Director, Clinical Operations, Oncology. Lead and direct the execution of multiple clinical programs within a Therapeutic Area Unit (TAU) with accountability for quality, budget, and timelines. Provide Clinical Operations leadership and oversee external partners to meet program objectives and regulatory requirements.
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 assigned programs.
- Provide Clinical Operations leadership under the direction of the Senior Director, Clinical Operations.
- Accountable for overall execution of assigned clinical program(s) with focus on quality, budget, and timelines.
- Oversee Strategic Partners and other vendors to meet organizational objectives and ensure compliance with ICH-GCP.
- Manage large, complex, high-risk programs or a suite of programs requiring multi-functional leadership to achieve goals.
Qualifications
- Bachelorโs Degree or international equivalent; Life Sciences preferred. Advanced degree highly desirable.
- 12+ years in the pharmaceutical industry, including 9+ years in clinical study management.
- Experience across early phase, Phase 2 and 3 studies, and global/international programs. Oncology experience required.
- Experience in more than one therapeutic area and in line management is advantageous.
- Strong leadership, project/program management, and matrix leadership capabilities.
- Expertise in global regulatory and compliance requirements for clinical research (e.g., US CFR, EU CTD, ICH GCP) with awareness of local country requirements.
- Supervisory experience; excellent teamwork, organizational, interpersonal, and problem-solving skills.
- Fluent business English (oral and written); ability to influence without authority.
- Entrepreneurial and innovative; able to drive change and operate in ambiguity; promotes knowledge sharing.
Education
- Bachelorโs Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable.