James Kaye, MD, DrPH, is a medical oncologist/hematologist, epidemiologist, and Senior Director of Epidemiology at RTI-HS. Dr. Kaye completed an internship and residency in internal medicine at the Beth Israel Hospital in Boston and a fellowship in medical oncology/hematology at the Dana Farber Cancer Institute. He then served on the faculty in the Department of Medicine at Harvard Medical School while practicing medical oncology/hematology and coordinating the clinical research program at Harvard Community Health Plan.

In 1991, Dr. Kaye joined the clinical development group at Genetics Institute, Inc. (later Wyeth, now Pfizer) where he directed clinical trials on several hematology/oncology products, two of which were approved for marketing. He participated in numerous Food and Drug Administration interactions, including investigational new drug and biologic license application submissions, advisory committee presentations, and label negotiations.

Dr. Kaye subsequently completed doctoral training in pharmacoepidemiology with a focus on pharmaceuticals and cancer risk. He was senior epidemiologist at the Boston Collaborative Drug Surveillance Program and a faculty member at Boston University School of Public Health, where he continues to serve as adjunct associate professor of epidemiology.

In 2009, Dr. Kaye joined RTI-HS, where he conducts research on postmarketing safety issues (especially cancer risk) and advises RTI-HS staff on a variety of health economics, biostatistics, and other projects relating to hematology/oncology drugs in development. He has chaired or participated in numerous independent data monitoring committees for clinical trials of drugs for the treatment of cancer or hematologic diseases, and he consults with clients on the assessment of cancer-related safety issues for drugs used in other indications. Dr. Kaye has authored more than 100 articles in the peer-reviewed medical literature.