{"$schema":"https://raw.githubusercontent.com/jsonresume/resume-schema/v1.0.0/schema.json","basics":{"name":"Robert Townsend","label":"VP of Clinical Operations","image":"https://saywise-production-profilepicturestoragebucket-kbfooccc.s3.amazonaws.com/profile-pictures/193973ec-4911-4a50-8b8a-2411092f4482/linkedin-1791292596409.jpg","summary":"I have extensive experience in global clinical trial development, execution, and management. I have been involved in every aspect of the clinical studies from study development, protocol development, start-up, close-out, database lock, PMA submission, PMA Panel committee review meeting and Post-Approval studies. Most recent achievements include approval of the Cartiva SCI device, a venture capital backed start-up, that resulted in entity acquisition by Wright Medical for $435m. Additional Experience Highlights: • Managed largest study ever conducted for clinical condition of first MTP OA • Low lost to follow up rate over the 2 year study (98% data available) • No BIMO Site Audits required by FDA • No internal Cartiva clinical/regulatory audit by FDA • Overwhelming positive vote by Orthopaedic Advisory Panel Meeting • Successfully met study endpoint for all pre-defined and post-hoc analyses as requested by the FDA • First synthetic cartilage implant device ever approved by the FDA • First PMA supported by only OUS data since 1976 • First PMA for any device used in the forefoot","location":{"city":"Alpharetta, GA, United States"},"profiles":[{"network":"LinkedIn","username":"roberttownsend79","url":"https://linkedin.com/in/roberttownsend79"}]},"meta":{"canonical":"https://saywise.com/member4788","version":"v1.0.0","lastModified":"2026-10-06T13:16:38.574Z"},"x_saywise":{"handle":"member4788","pronouns":null,"availability":null,"oneLiner":"I have extensive experience in global clinical trial development, execution, and management. I have been involved in every aspect of the clinical studies from study development, protocol development, start-up, close-out, database lock, PMA submission, PMA Panel committee review meeting and Post-Approval studies. Most recent achievements include approval of the Cartiva SCI device, a venture capital backed start-up, that resulted in entity acquisition by Wright Medical for $435m. Additional Experience Highlights: • Managed largest study ever conducted for clinical condition of first MTP OA • Low lost to follow up rate over the 2 year study (98% data available) • No BIMO Site Audits required by FDA • No internal Cartiva clinical/regulatory audit by FDA • Overwhelming positive vote by Orthopaedic Advisory Panel Meeting • Successfully met study endpoint for all pre-defined and post-hoc analyses as requested by the FDA • First synthetic cartilage implant device ever approved by the FDA • First PMA supported by only OUS data since 1976 • First PMA for any device used in the forefoot","profileUrl":"https://saywise.com/member4788","markdownUrl":"https://saywise.com/member4788/profile.md","pdfUrl":"https://saywise.com/member4788/resume.pdf","archetype":{"code":"HS-DG","name":"Launchpad Navigator","url":"https://saywise.com/sca/e2969ac8920f","rarity":"One of the first Launchpad Navigators on Saywise"}},"work":[{"name":"NEXT Life Sciences","position":"Vice President Clinical Operations","url":"https://nextlifesciences.org","startDate":"2025-11-01"},{"name":"ReGelTec, Inc","position":"Senior Director Clinical Affairs","url":"https://regeltec.com","startDate":"2020-10-01","endDate":"2025-11-01"},{"name":"Self-employed","position":"RT Clinical Consulting","location":"Alpharetta, Georgia, United States","startDate":"2020-05-01"},{"name":"Unknown","position":"RT Clinical Consulting","location":"Alpharetta, Georgia, United States","url":"https://currituck.k12.nc.us","startDate":"2020-05-01"},{"name":"Aziyo Biologics, Inc.","position":"Director of Clinical","url":"https://aziyo.com","startDate":"2019-11-01","endDate":"2020-05-01"},{"name":"Wright Medical","position":"Director Clinical Operations","url":"https://wright.com","startDate":"2018-10-01","endDate":"2019-11-01"},{"name":"Cartiva, Inc.","position":"Director Clinical Operations","location":"Alpharetta, GA","url":"https://cartiva.net","startDate":"2011-05-01","endDate":"2019-11-01","summary":"Clinical Project Manager at Cartiva. Inc, a private, venture capital-backed company dedicated to the development of novel therapies and technological advances in the orthopaedic industry. The Clinical Project Manager role has centered around management of the Phase III Prospective, Randomized, Multi-centered Clinical Trial (the MOTION study) of the Cartiva Synthetic Cartilage Implant. The Cartiva implant has gained approval for use in various international markets and most recently received a favorable Panel Advisory vote as part of the PMA review process. The PMA review process comes after completion of the MOTION study in the United Kingdom and Canada where the Cartiva device outcomes were successfully compared to the standard of care, fusion. The MOTION study was awarded the 2015 Roger A. Mann award winner for best clinical study of 2015."},{"name":"Carticept Medical, Inc.","position":"Clinical Coordinator","startDate":"2010-04-01","endDate":"2011-05-01"},{"name":"PPD","position":"Clinical Submission Specialist","url":"https://ppd.com","startDate":"2008-02-01","endDate":"2010-05-01"},{"name":"Voith Paper R&D","position":"Research Assistant","startDate":"2005-08-01","endDate":"2008-02-01"}],"education":[{"institution":"Georgia Southern University","studyType":"BS in Biology","startDate":"1998-01-01","endDate":"2002-01-01"}],"skills":[{"name":"Medical Devices"},{"name":"Clinical Trials"},{"name":"Clinical Research"},{"name":"FDA"},{"name":"Orthopedic"},{"name":"Clinical Development"},{"name":"Surgery"},{"name":"CTMS"},{"name":"Pain Management"},{"name":"CRO"},{"name":"Management"},{"name":"Medicine"},{"name":"GCP"},{"name":"EDC"},{"name":"ICH-GCP"},{"name":"Orthopedics"},{"name":"Oncology"},{"name":"U.S. Food and Drug Administration (FDA)"}],"certificates":[{"name":"ICH-GCP"}]}