Senior Director, Clinical Operations
Kathleen has over 24 years of well-rounded experience in clinical research and drug development from academia to industry, supporting clinical trials from the planning stages through NDA submission and post marketing objectives. She has worked for clinical sites, CROs and biotech companies in roles of research assistant, study coordinator, CRA, global project and study management, and clinical operations leadership. She has worked in a broad range of therapeutic areas including immuno-oncology, rare diseases and cardiovascular, with extensive experience in complex study designs and procedures and critical care environments. Kathleen has implemented, performed or overseen all aspects of clinical operations, from feasibility and start-up through database lock, clinical study report and closure, working with cross-functional teams to ensure high quality delivery of projects.
Kathleen strives to understand the needs of each player in the clinical research puzzle, aiming to bring teams together through open, transparent and proactive collaboration in order to achieve the common goal of improving patient’s lives. She had the honor of working on COVID-19 therapeutics in 2020, and successfully implemented remote monitoring paradigms and hybrid study designs for numerous therapeutic indications during COVID-19 restrictions. Kathleen is passionate about improving access to clinical trials for underserved and under-represented populations by working to design and execute research that brings the study to the patient and was part of the Decentralized Trials and Research Alliance (DTRA) early stage initiative towards defining best practices for decentralized clinical trials.