Denise Weaver Breiner, MBA
About Denise Weaver Breiner, MBA
Denise Weaver Breiner, MBA, serves as the Director of Clinical Affairs at AtriCure, Inc., where she has worked since 2016. With over 20 years of experience in clinical research and regulatory affairs, she has held various leadership roles and authored significant regulatory documentation.
Current Role at AtriCure
Denise Weaver Breiner serves as the Director of Clinical Affairs at AtriCure, Inc. since 2016. In this role, she oversees clinical operations and ensures compliance with regulatory standards. Her responsibilities include managing clinical trials and collaborating with various stakeholders to advance the company's clinical objectives. AtriCure is focused on developing innovative medical devices for the treatment of atrial fibrillation and other cardiac conditions.
Previous Experience at OptumInsight
Denise worked at OptumInsight as Senior Manager of Clinical Operations from 2011 to 2013. During her tenure, she was responsible for overseeing clinical operations and contributed to the development of clinical strategies. She authored annual FDA reports and safety reports, showcasing her expertise in regulatory documentation and compliance.
Career at Kendle International, Inc.
Denise spent ten years at Kendle International, Inc. from 1997 to 2007, where she held multiple roles including Department Head of Quality Control, Global Program Director, and Senior Project Leader. Her experience in these positions contributed to her extensive knowledge of clinical research and quality assurance processes within the pharmaceutical and medical device industries.
Education and Academic Background
Denise holds an MBA with a focus on International Management, Marketing, and Finance from the University of Cincinnati, where she studied from 1999 to 2001. She also completed the Executive Development Program at Northwestern University's Kellogg School of Management in 2018. Earlier, she earned a BA in Comparative Anatomy and Physiology from The University of Toledo, where she participated in the Honors Program from 1988 to 1992.
Expertise in Regulatory Affairs
Denise has over 20 years of strategic involvement in clinical research, with significant experience in regulatory affairs. She has hosted FDA audits at both sponsor and multiple site levels, achieving no findings, which demonstrates her compliance and audit management skills. Additionally, she has extensive experience with FDA Pre-Sub and Q-Sub meetings, further indicating her strong background in navigating regulatory processes.