Karim Anton Calis, Pharm.D., M.P.H., FASHP, FCCP

Director of Clinical Research and Compliance

301 435 0092
NIHBC 10 - CRC BG RM 1-3130

Karim Anton Calis, Pharm.D., M.P.H., FASHP, FCCP, was named director of clinical research and compliance for the Division of Intramural Research in 2017. He also holds an appointment as chair of the NIH Office of Intramural Research’s institutional review board (IRB). He is a senior scientist with training and experience in pharmacotherapy, public health, clinical research, and drug development.

From 1989 to 2009, Dr. Calis directed the NIH drug information and pharmacotherapy consultation service. His clinical practice and research in the intramural program focused on the treatment of endocrine and reproductive disorders, pediatric rare diseases, and childhood growth and obesity.

Prior to joining NIH, Dr. Calis was a medical reviewer and acting clinical team leader for the U.S. Food and Drug Administration (FDA), conducting clinical efficacy and safety reviews of FDA-regulated drugs and biologics for the Center for Drug Evaluation and Research’s Division of Metabolism and Endocrinology Products. He served as senior clinical analyst in the FDA Office of Medical Policy and acting clinical team leader in the Division of Clinical Trial Quality, working on medical, scientific, and regulatory policy initiatives to improve clinical trial oversight and enhance the safety and integrity of clinical research. He also was a clinical professor at the University of Maryland and Virginia Commonwealth University.

Dr. Calis served as chair of the Endocrinology Expert Committee, vice chair of the Medicare Model Guidelines Expert Committee, member of the Executive Committee of the Council of Experts of the United States Pharmacopeia, as well as chair of several IRBs, data monitoring committees, and other professional committees and task forces. He also served as a reviewer and editorial board member for numerous medical journals. He has authored nearly 200 peer-reviewed publications in high-impact journals, medical textbooks, and authoritative electronic media, including national guidelines and best practices for data monitoring committees. He is the senior founding editor of a textbook dedicated to women’s health pharmacotherapeutics across the lifespan.

Dr. Calis earned his bachelor’s and doctorate from the University of Maryland and master’s degree in public health from the Johns Hopkins University Bloomberg School of Public Health.

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