Senior Director, RWE Pharmacoepidemiology & Safety Head
Gilead Sciences, Inc
Francesca Kolitsopoulos is the Oncology Pharmacoepidemiology & Safety Head at Gilead Sciences. In this role, Francesca is responsible for leading the strategic design, implementation, and interpretation of pharmacoepidemiology RWE oncology studies at Gilead, utilizing RWE and RWD including large EMR and claims databases to help inform decision-making throughout the product’s lifecycle. Her role includes accurate disease and product safety characterization to improve the likelihood of success of early phase clinical trials, generating pivotal epidemiologic evidence to support regulatory filings, and assessing diversity needs in populations under study. Francesca has been leading observational studies and clinical trials for over 22 years in the pharmaceutical industry, first at Bristol-Myers Squibb, and in roles of increasing responsibility at Pfizer since September 2004. Prior to joining Gilead earlier this year, Francesca led a team of epidemiologists that provided the epidemiologic / RWE strategy for product effectiveness and safety for Pfizer’s Oncology Franchise. She served as Business Process Lead for non-interventional study SOPs where she devised a suite of processes/tools for RWE study execution. Her extensive expertise leading primary data collection studies, large observational cohort studies, and large pragmatic trials are evidenced by her published RWE studies. These include studies for well-known products such as Zoloft, Viagra and Geodon, while her previous ongoing work in cancer health disparity research, in collaboration with Vanderbilt University Medical Center, will be submitted for publication later this year. Francesca’s academic training began in Veterinary Technology, where she holds a Bachelor of Science degree from Quinnipiac University, and later, a Master of Public Health in Epidemiology from Columbia University. In her spare time, Francesca enjoys interior design, cycling, travel, and time spent with her 3 sons, husband, and French bulldog, Eze.