Flavio Leonin, MD
About Flavio Leonin, MD
Flavio Leonin, MD, is a Senior Manager of Clinical Affairs at pSivida, with extensive experience in clinical research and operations across multiple pharmaceutical companies. He has managed significant clinical studies and collaborated with regulatory agencies to ensure protocol compliance and approval.
Work at pSivida
Flavio Leonin serves as the Senior Manager of Clinical Affairs at pSivida, a position he has held since 2014. In this role, he oversees clinical operations and manages various aspects of clinical trials. His responsibilities include maintaining clinicaltrials.gov information and providing status update reports to senior management. His extensive experience in clinical research supports the company’s commitment to advancing ophthalmology studies.
Previous Experience in Clinical Research
Flavio Leonin has held several significant positions in clinical research prior to his current role. He worked at Merck Research Laboratories as a Senior Clinical Trials Associate - Consultant from 2009 to 2011. He also served as a Regional Clinical Research Associate at Boehringer Ingelheim from 2000 to 2001, and as a Clinical Trials Manager - Consultant at Pfizer Consumer Healthcare from 2005 to 2006. His diverse experience spans multiple organizations and roles, contributing to his expertise in clinical trials.
Education and Expertise
Flavio Leonin earned his Doctor of Medicine (MD) from Perpetual Help School of Medicine, where he studied from 1987 to 1991. He also holds a Bachelor of Science (BS) in Biology from Boston College, completed from 1980 to 1984. His educational background provides a strong foundation for his career in clinical affairs and research management.
Clinical Trial Management Experience
Throughout his career, Flavio Leonin has managed clinical and operational aspects of multiple Phase III global ophthalmology studies. He has experience with planned enrollment of 300 patients across six countries. His responsibilities have included preparing and reviewing study documents such as protocols, informed consent forms, and monitoring reports, ensuring compliance and quality in clinical research.
Collaboration with Regulatory Agencies
Flavio Leonin has collaborated with the FDA on Phase III protocols, which led to protocol approval and modifications in primary efficacy endpoints and statistical analysis. His involvement in the development and approval of vendor/site budgets and various study plans demonstrates his ability to navigate complex regulatory environments effectively.