Alexandra D.J. Mancini, M.Sc.
Senior Vice President, Clinical and Regulatory Affairs.
Ms. Mancini has over 30 years of global biopharmaceutical R&D experience with a particular emphasis on clinical development and regulatory affairs. Ms. Mancini has been an executive with several biotech companies, overseeing a wide range of drug development activities. As Sr. VP of Clinical & Regulatory Affairs at Sirius Genomics, her role included identifying and managing external resources for medical expertise in sepsis; clinical data management; and statistical theory, programming and analyses. While at INEX Pharmaceuticals as Sr. VP of Clinical & Regulatory Affairs, Ms. Mancini oversaw Clinical Research, Medical Affairs, Clinical Data Management, Medical Writing, Regulatory Affairs, and Quality Assurance for oncology. She served as VP of Regulatory Affairs at QLT Inc. for oncology and ocular diseases, playing a significant role in the development of VISUDYNE from the preclinical stage through to its approval as the first drug for age-related macular degeneration. While at QLT, Ms. Mancini also led the regulatory approval process for the anticancer drug PHOTOFRIN and its associated medical devices, the first drug-device combination product approved by the US Food and Drug Administration. Ms. Mancini has led the data analysis and assimilation, writing, submission and subsequent defense of drug submissions to regulatory agencies around the world, leading to several drug approvals and label extensions.
Ms. Mancini holds a Master of Science degree from the University of Toronto. She is also a Visiting Lecturer at the Segal Graduate School of Business, Simon Fraser University.