Denise Weaver Breiner

Denise Weaver Breiner, MBA has a wealth of experience in the clinical affairs and research field. Denise Weaver served as the Director of Clinical Affairs at AtriCure, Inc., where they successfully directed and managed medical device studies and hosted FDA audits with no findings. Denise Weaver also played a hands-on role in FDA communications and strategy development. Prior to this, they worked as the Manager of Clinical Affairs at AtriCure, Inc.

Before joining AtriCure, Inc., Denise worked as the Senior Manager of Clinical Operations at OptumInsight, where they led a global effort for legal entity updates and played a key role in the development of an Electronic Data Capture System. Denise Weaver also redeveloped the program management infrastructure and processes.

Denise gained valuable experience as a Business Consultant in the Clinical Affairs department at Ethicon Endo-Surgery, affiliated with Medical Device Research. Here, they contributed their expertise from 2006 to 2010.

Denise Weaver also has an extensive background at Kendle International, Inc., where they held various positions, including Department Head (Quality Control), Global Program Director, Assistant Director, and Senior Project Leader. In these roles, Denise led a team of Clinical Research Associates (CRAs), managed high-profile studies, and served as a Clinical Operations Subject Matter Expert (SME) on FDA Panel Prep Teams.

Denise's career in the field of clinical research began at Phoenix International Life Sciences (PILS) as a Project Manager. Here, they managed various Phase I pharmaceutical trials focused on pharmacokinetics and safety.

Overall, Denise Weaver Breiner, MBA possesses a wide range of expertise in clinical affairs and research, with a strong focus on FDA compliance and strategy development.

Denise Weaver Breiner holds an Executive Development Program degree from Northwestern University - Kellogg School of Management, which they completed in 2018. In 2001, they earned an MBA from the University of Cincinnati, specializing in International Management, Marketing, and Finance. Denise also obtained their Bachelor of Arts degree from The University of Toledo in 1992, where they completed the Honors Program in Comparative Anatomy & Physiology. In 2020, they became a member of the Project Management Institute.