Thomas Gould Email & Phone Number

Oct 2013 – present Independent Consultant, Minneapolis, Minnesota Supporting start up efforts globally. Consultations with start up medical device companies on their efforts with general business development. Assistance with Clinical Affairs departmental planning, site selection and recruitment, protocol development, patient trial enrollment, and trial execution including PMA submission. Assist with the creation of regulatory strategies and submissions globally. Sales and marketing strategies, including planning and budgeting for both pre-approval and commercial product rollouts.

Responsible for management of 5 ongoing Clinical Trials and global clinical support as well as led and directed all US sales. Creation and management of Data Safety Monitoring Boards, Adverse Event Adjudication Committees, and Scientific Advisory Boards for all global clinical trials. Manage global CRO activities with all sites. Clinical support for development of next generation LVAD design including design of animal protocols and animal studies.. Recruited and negotiated contracts with all Clinical Trial sites. Manage all aspects of global clinical and regulatory site data collection and field clinical support. Developed all training materials for both surgical implant and clinical support. Successful FDA trial audits.

Au

Lead this Australia start up company’s US efforts since 2005. First US employee. Identified and successfully negotiated contracts, site training and IRB approvals at every site (32) in 4 clinical trials. 22 US employees, 7 direct reports, with 155 employees worldwide, plus 9 distributors. Achieved CE Mark in 2007, successfully completed US Bridge to Transplant Feasibility Trial, CE Mark Trial, CE Post Market Trial, and US Bridge to Transplant Pivotal Trial. Prepared PMA submission for FDA approval for Bridge to Transplant labeling. Total US P&L responsibility. Manage all aspects of US business. Consult with Australasian and European country managers and coordinate worldwide marketing efforts. Created and managed all CRO activities. Created and managed all DSMBs, AEAC, and SAB, as well as Anticoagulation and Infection Control committees.

Managed midwesteern territory and was promoted to Director of Field Operations for this Left Ventricular Assist compnay founded by the late Dr. Michael Debakey.

Intorduce this Canadian EP company into the US and managed all aspects of the US midwestern business.

Sold EP mapping systems and services in the midwest. Company was sold to 3M.

Manages midwestern sales territory of industry leader in Left Ventricular Assist Devices. Company was sold to competitor, Thoratec.

President's club 3 times, Rookie of theYear, Highest profit territory 8 times. # 1 Capital equipment sales (Haemonetics) 5 times. President's Award for Overall Sales acheivenent. Grew territory 500%.