Lynda M. Cristiano

US-trained and licensed pulmonary and critical care physician with ~18 years of extensive experience in pharmacovigilance and benefit-risk management. Broad experience with a risk management system for a product with a complex distribution system with elements to assure safe use; presented risk management learning to regulatory authorities and led teams to successful completion of a global phase IV observational program and pregnancy registry. Highly effective executive with excellent leadership and communication skills and a proven track record of success providing strategic leadership in building successful teams, development of risk management plans, global filings, new drug approvals, and product launches. Experience includes rare diseases, neurology, and immunology/inflammation therapeutic areas. Responsible for providing strategic input for clinical studies throughout product development: phase 1/2a, phase 3, and phase 4 observational studies, and critical assessment of post marketing data. Current position is Senior Vice President, Therapeutic Area Head of Pharmacovigilance Immunology and Inflammation at Sanofi, managing a busy and exciting therapeutic area.