Executive Director of Clinical Operations

About the Company

Respected biotechnology (BioTech) company

Industry Biotechnology

Type Privately Held

About the Role

The Company is in search of an Executive Director of Clinical Operations to provide strategic leadership and operational oversight for clinical trial activities, particularly within an early-phase drug development setting. The successful candidate will be responsible for leading the Clinical Operations team, ensuring the efficient and compliant conduct of trials, and maintaining a strong focus on cross-functional collaboration, vendor management, and inspection readiness. This role demands a professional with a Bachelor's degree (advanced degree in Biomedical or Life Sciences preferred), a background in oncology, and expertise in all stages of the clinical trial lifecycle, including regulatory inspection readiness. Experience in high-growth, dynamic environments with global, matrixed team management is essential, as is proficiency in creating and maintaining SOPs, quality documents, and compliant operational environments.

Key responsibilities for the Executive Director include providing strategic guidance to meet corporate goals, overseeing all aspects of clinical trial execution, and integrating clinical operations expertise into development activities. The role also involves developing and monitoring key performance indicators, fostering cross-functional communication, and representing clinical operations in stakeholder meetings. The ideal candidate will have a strong understanding of GCP, ICH guidelines, and clinical documentation standards, as well as proficiency in clinical systems. They should be adept at managing and mentoring a team, guiding vendor selection and oversight, and driving process improvement initiatives to enhance operational efficiency. The position requires excellent organizational, communication, and leadership skills, as well as the willingness to travel internationally for clinical site engagement and oversight.

Travel Percent Less than 10%

Functions

CEO/President Non-Profit Management Medical Care/Hospital Administration