Lesko was director of the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research (CDER) at the FDA for 16 years until his retirement in July 2011. He currently is clinical professor and director of the Center for Pharmacometrics and Systems Pharmacology at the University of Florida College of Pharmacy at Lake Nona in Orlando, Fla.
At the FDA, Lesko created a new Division of Pharmacometrics, which is responsible for the quantitative analysis of dose-response, PK-PD relationships, PBPK to support drug labels and NDA approvals, and the development of drug-disease models to support clinical trial simulations. Lesko led a systems pharmacology program that used mechanistic approaches to investigate drug safety issues and bioinformatics methods to predict off-target effects. He also advanced precision medicine by championing the inclusion of new genetic information in on-market drug labels.