Executive Director, Clinical Operations
Remote
Clinical – Clinical Leadership /
Full Time /
Remote
ABOUT THE ROLE
The Executive Director of Clinical Operations is critical to the success and growth of Topography Health. This is an opportunity to work in a dynamic and collaborative environment where your contributions significantly impact patient care and clinical research quality. As a Clinical Research Subject Matter Expert, you will be providing the expertise necessary to guide our clinical site leaders, and establish a robust quality and regulatory operational framework. You will be pivotal in driving clinical research excellence, enhancing patient safety, and ensuring high-quality clinical trial execution. An ownership mindset will be key, with a passion for building scalable, replicable systems. Tasked with managing the full lifecycle of clinical trial operations, from optimizing for site selection and study start-up to participant enrollment and study activity management, this role serves as the key decision-maker for clinical, quality, and regulatory matters. The position requires close collaboration with senior management to set trial goals and strategies, and to ensure the success of studies. You will also act as the primary liaison for the clinical team, facilitating strategic planning, and problem resolution to maintain operational effectiveness and compliance.
KEY RESPONSIBILITIES
Oversee all of Clinical Operations at Topography Health, embodying expert knowledge and ownership of clinical trial processes.
Oversee and manage the daily operations of the clinical research department, ensuring compliance with regulatory standards and achieving trial objectives.
Lead and mentor the clinical operations team, including Regional & Site Managers and Quality & Regulatory teams, fostering an environment of growth and learning.
Develop and implement Standard Operating Procedures (SOPs), training programs, and quality assurance measures to streamline operations and maintain high standards of clinical research.
Direct the planning, start-up, initiation, and execution of clinical trials, including participating in feasibility reviews, preparation for and hosting Site Qualification Visits, advancing study start-up, driving patient enrollment, and overall management of study activities.
Serve as the primary point of contact for clinical operations, offering strategic guidance and making judgment calls on key clinical and regulatory decisions.
Collaborate with senior management to define enrollment goals, strategies for patient recruitment, and overall study success.
Build advancing capabilities at Topography’s clinical trial sites, working with internal and external partners to unblock barriers to trial execution.
Facilitate effective communication and collaboration among clinical teams and stakeholders to ensure alignment with clinical operations objectives and operational efficiency.
Manage and resolve complex clinical and regulatory issues, ensuring trials are conducted in compliance with GCP, ICH and other relevant guidelines.
MINIMUM QUALIFICATIONS
Bachelor's Degree or equivalent 4 years of work experience
15+ years of experience in Clinical Research, serving as a Clinical Research Coordinator or similar role, with advancing levels of seniority and responsibility
10+ years of experience in clinical trial management and regulatory compliance.
10+ years In-depth knowledge of clinical research operations, GCP, FDA regulations, and trial management systems.
8+ years of experience managing and developing a high-performing team.
PREFERRED QUALIFICATIONS
Located in one of the following cities
Ann Arbor, MI
Baltimore, MD
DC Metro
Denver, CO
Madison, WI
Nashville, TN
NYC, NY
San Jose, CA
Los Angeles, CA
San Diego, CA
