Over 22 years of experience in all facets of clinical research including 20 years in medical device clinical research. My experience includes time at one of the top-three medical devices companies as well as having experience in the start-up atmosphere. I have been responsible for the development and management of over thirty (30) IDE studies including protocol development through final report/submission to regulatory authorities. My experience includes primarily Class III devices with indications in neurology (spinal cord and deep brain stimulation), cardiac (pacemaker, ICD, valves and LVAD), vascular (stents), and orthopedics. Geographically, I have significant experience managing trials in the United States, Canada, Europe, and Hong Kong/China including extended assignments within these regions. Through various roles within the industry, I have proven excellence in the management of clinical trials and associated regulatory interaction; therapeutic and technological expertise; and KOL development and management.
“I am able to help guide the discussion around clinical trial strategy and design for medical devices from FIM through post-market.”