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Brad joined Experien Group in 2009 with over 10 years clinical research experience working in medical device companies. He has been employed by large device companies as well as successful start-ups, and he possesses particular expertise with cardiovascular and spinal orthopedic devices. Brad has extensive experience in designing, managing and supporting U.S. and OUS clinical trials, including feasibility studies, IDE trials and post-market studies.
At Experien Group, Brad directs clinical and regulatory activities, including clinical trial design and study management for U.S. and international trials. He supports regulatory submissions, including U.S. IDE submissions as well as OUS Notified Body, Competent Authority and Ethics Committee submissions. Brad performs analyses of marketed products' compliance to U.S. and international regulatory reporting requirements and he implements changes to bring products into compliance, as needed. Brad's primary functions include:
- Clinical strategy development
- Clinical protocol development, including Informed Consent, Case Report Forms, trial agreements, etc.
- Clinical trial management, including budgets, timelines, site coordination, and monitoring
- Clinical study documentation for regulatory submissions (e.g., IRB or Ethics Committee packages)
- Formulation and facilitation of Data Safety Monitoring Boards (DSMBs) and Clinical Events Committees (CECs)
- Independent core lab selection and management
- Clinical report writing
- U.S. and international regulatory submissions and compliance activities
PAST COMPANIES AND EXPERIENCE
Prior to joining Experien Group, Brad held management positions at Medtronic and Abbott Vascular. He also worked for start-up companies, including Conor Medsystems and PharmaSonics. As a clinical study director for several companies, Brad has presented at investigator meetings and conducted Clinical Advisory Board meetings. While he has been primarily involved with clinical research for medical device companies, Brad has also supported R&D, manufacturing, marketing and sales departments. He orchestrated post-acquisition activities for cross-functional teams at Medtronic following the purchase of Kyphon and he helped CryoVascular develop both public and physician information campaigns to increase market penetration.
EDUCATION
Brad received a BS degree in Environmental Studies from San Jose State University in San Jose, California. |
