Roger D. Klein, M.D., J.D.

Roger D. Klein, M.D., J.D., is a board-certified molecular pathologist and attorney who was formerly Chief Medical Officer of OmniSeq, Inc., a tumor profiling company that was acquired by LabCorp. Dr. Klein continued in a similar capacity at LabCorp helping to ensure the successful integration of the company. While at OmniSeq, he oversaw the company’s Knowledge Informatics/Data Analysis group.
Dr. Klein has been medical director of molecular pathology at several academic institutions, including Cleveland Clinic, where he oversaw molecular oncology and germline genetic testing. In addition, he has served as a medical, strategic, and regulatory consultant in the biotechnology, clinical laboratory, diagnostics, healthcare, artificial intelligence, medical device, and investment industries. A leading figure in the field, Dr. Klein has advised the Departments of Health & Human Services, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and the Centers for Disease Control and Prevention, and has held leadership roles on and participated in numerous professional society committees at the Association for Molecular Pathology, the College of American Pathologists, the American Society of Clinical Oncology, the Clinical Laboratory Standards Institute, and the American Medical Association. He is a former Co-Chair of CDC’s Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group.
He has served as a mentor with the NYU Stern School of Business’ Endless Frontier Labs startup incubator, a Faculty Fellow at the Center for Law, Science and Innovation at Arizona State University Law School, an expert on FDA and Health with the Regulatory Transparency Project, a Policy Advisory to Heartland Institute, and a member the Board of Advisors of the Liberty & Law Center at the Antonin Scalia Law School at George Mason University. He has over 60 peer-reviewed articles and book chapters, has been a member of several editorial advisory boards, and has received numerous professional and community awards.
Dr. Klein completed medical school and an internship at Case Western Reserve Medical School, residency and fellowships at Yale Medical School, and a fellowship at Mayo Clinic. He earned his law degree at Yale Law School, where he was an articles editor for the Yale Journal on Regulation and an Olin Fellow in Law, Economics, and Public Policy. He is licensed to practice medicine in Ohio, Florida, and New York and licensed to practice law in Ohio and the District of Columbia. Dr. Klein is a member of the U.S. Supreme Court Bar.