Kristen McCaleb

Kristen McCaleb is a seasoned professional in the field of medical affairs operations and drug development, currently serving as the Senior Director of Medical Affairs Operations at Guardant Health since December 2024. With prior experience at Frontier Medicines, Kristen excelled in technical operations by building a team of over 60 consultants to successfully manufacture the company's first clinical candidate and secure an IND without agency inquiries on the CMC module. Additional roles included leadership positions at Gilead Sciences, Exact Sciences, and Invitae, focusing on alliance management, global clinical affairs, and program management, respectively. Kristen's background in medicinal chemistry at Roche and consulting experience further positioned Kristen as an expert in optimizing processes and enhancing collaboration across multidisciplinary teams. Kristen earned a Ph.D. in Organic Chemistry from the University of Colorado Boulder and a B.S. in Chemistry with High Distinction from the University of Illinois Urbana-Champaign.