Jay Donosky, MBA
About Jay Donosky, MBA
Jay Donosky, MBA, is the Vice President of Clinical Affairs at Allurion Technologies, bringing extensive experience in clinical research and operations across various organizations. He has held significant roles at companies such as Amgen, W.L. Gore & Associates, and Edwards Lifesciences, and he possesses expertise in managing clinical studies for Class III medical devices.
Current Role at Allurion Technologies
Jay Donosky serves as the Vice President of Clinical Affairs at Allurion Technologies since 2023. In this role, he oversees clinical operations and strategies, focusing on the development and management of clinical studies related to the company's medical devices. His leadership contributes to the advancement of clinical research initiatives within the organization.
Previous Experience in Clinical Affairs
Before joining Allurion Technologies, Jay Donosky held various positions in clinical affairs. He worked at Edwards Lifesciences as Senior Director of Clinical Affairs Global Strategy & Program Management from 2021 to 2023. He also served as Clinical Affairs Leader for Cardiac at W.L. Gore & Associates from 2017 to 2021, and as Associate Director of Clinical Operations at Tanox, Inc. from 2006 to 2007. His diverse experience spans multiple organizations and roles in the clinical research field.
Educational Background and Qualifications
Jay Donosky holds an MBA from the W. P. Carey School of Business at Arizona State University, which he completed from 2007 to 2009. He also studied at Indiana University School of Medicine, where he pursued Medicine. Additionally, he earned a B.S. in Biology from the University of Southern Indiana and a B.S. in Business from Miami University. His educational background supports his expertise in clinical operations and project management.
Expertise in Clinical Research and Project Management
Jay Donosky possesses extensive expertise in managing Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) studies for Class III medical devices. He has significant experience leading clinical research across all phases of biopharmaceutical studies, including First-in-Human (FIH) and Early Feasibility Studies (EFS). He holds a Project Management Professional (PMP) certification, indicating a high level of proficiency in project management.
Teaching and Instructional Roles
In addition to his corporate roles, Jay Donosky has served as an Adjunct Faculty Associate at Arizona State University from 2010 to 2012. He specializes in Project Management and Clinical Operations, contributing to the education of graduate-level students in these fields. His instructional experience complements his professional background in clinical research.