Randall Kaye, MD serves as the Global Head of Medical Affairs at SSI Strategy, a boutique consulting firm focused on Medical Affairs, Pharmacovigilance and Clinical Development. In Dr. Kaye’s role at SSI Strategy, he focuses on providing a medical and scientific perspective to transformative initiatives in Medical Affairs and Pharmacovigilance. He plays a key role in SSI’s bespoke advisory services and regulatory compliance service offerings.
Most recently, Dr. Kaye was Chief Medical Officer at Axsome Therapeutics, a biopharmaceutical company developing novel therapies for the treatment of pain and other neurological diseases. While at Axsome, Dr. Kaye developed and executed all Clinical Research functional areas that resulted in the initialization of three clinical programs (IND Filing, FPI) in less than one year. Prior to joining Axsome, Dr. Kaye was Chief Medical Officer at Avanir Pharmaceuticals (acquired by Otsuka), a CNS specialty company. While at Avanir, Dr. Kaye provided leadership and vision to the clinical, regulatory and medical affairs areas, and supported the commercialization of new products from a medical, scientific, regulatory, technical and quality perspective. Prior to Avanir, Dr. Kaye served in a variety of medical affairs leadership positions at Scios Inc. (acquired by Johnson and Johnson) a cardiovascular specialty company, InterMune Inc. (acquired by Roche), a specialty company focusing on Idiopathic Pulmonary Fibrosis and Pfizer Inc.
Dr. Kaye earned his Doctor of Medicine, Masters in Public Health and Bachelor of Science degrees at The George Washington University in Washington, D.C. Dr. Kaye trained in Pediatrics at the University of Massachusetts Medical School and was a Research Fellow in Allergy and Immunology at Harvard Medical School.