Dr. Carmen Bozic is Senior Vice President of Global Development at Biogen. Her department is responsible for developing and obtaining regulatory approval of therapies in Biogen’s therapeutic focus areas of Neurology, Immunology, and Hematology. The functions in her department include global clinical development, regional clinical development in Japan and Europe, safety and benefit risk management, global clinical operations, biostatistics, medical writing, data management and statistical programming.
Dr Bozic is an experienced drug development leader with over 17 years of biopharmaceutical industry experience with progressively increasing responsibilities in multiple functions and therapeutic areas. As the former Global Head of Safety and Benefit-Risk Management at Biogen for several years, she led a world-class organization that was accountable for patient safety for the pre and post-approval pipeline and addressed complex issues in safety and benefit-risk management. Dr. Bozic has also overseen functions accountable for the regulatory filing and approvals of multiple therapies, including TECFIDERA (dimethyl fumarate) and PLEGRIDY (pegylated interferon beta-1a) for multiple sclerosis, as well as ELOCTATE (Factor VIII Fc fusion protein) and ALPROLIX (Factor IX Fc fusion protein) for the treatment of severe Hemophilia A and B in multiple countries. She led the development of the risk management plan for TYSABRIÃ’ (natalizumab) and presented on this topic at an FDA Advisory Committee, leading to the approval of TYSABRI for the treatment of multiple sclerosis. She has also served as the industry representative to the FDA’s Risk Communication Advisory Committee and is a member of PhRMA’s Clinical and Preclinical Development Committee.
Dr. Bozic received an MD degree and did her residency in internal medicine at McGill University in Montreal, Canada, completed a fellowship in Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital in Boston, and was an Associate Physician at Beth Israel Deaconess Medical Center and Harvard Medical School before joining the biopharmaceutical industry. She is a frequent lecturer and speaker on benefit-risk and other drug development topics nationally and internationally.