Marc possesses over 11 years of industry experience supporting clinical research programs for medical devices. He joined Experien Group (now Veranex) in early 2020 to support the firm’s growing clinical department with his experience in managing all aspects of clinical studies from clinical strategy, study design and development, through data analysis and clinical report generation.
At Veranex, Marc supports clients by directing and managing clinical projects, including U.S. and international clinical study programs from first-in-human (FIH)/feasibility studies (FS) to large randomized controlled pivotal trials in pursuit of medical device commercialization. His central responsibilities include:
- Participating on design teams throughout the product life cycle
- Providing input on clinical strategy development to optimize the client’s clinical evidence goals
- Directing clinical elements and generating clinical study documentation required for FDA, U.S., and OUS regulatory agency submissions, including pre-submission packages and investigational device exemption (IDE) applications, as well as final clinical study reports for de novos, 510(k)s, PMAs, and EU technical files and design dossiers
- Providing clinical study operational leadership, oversight, and support from study planning through close-out and analysis in accordance with projected timelines; this includes study/site activation activities, management of clinical study databases, formulation and facilitation of Data Safety Monitoring Boards (DSMBs), Clinical Events Committees (CECs), and core labs with the study sponsor to ensure study success
Past companies and experience
Prior to joining Veranex, Marc spent two years at Santen leading their medical device clinical operations department and global clinical programs to support their PMA submission, OUS submissions, and EU postmarket clinical follow-up requirements for a novel ophthalmic implant to treat primary open angle glaucoma. Marc also spent nine years within various divisions of Medtronic in roles of increasing leadership capacity in the clinical affairs discipline. Marc garnered product experience with significant risk (SR) and non-significant risk (NSR) technologies, capital equipment, implantables, medical instrumentation, including nerve integrity monitors, robot-assisted surgery systems, MRI-guided laser ablation systems, surgical navigation systems, sinus surgery tools, ophthalmic implants, hydrocephalus shunts, external ventricular drainage and monitoring systems, cranial fixation systems, and neuro-endoscopes. Marc has extensive experience in influencing design and development from a clinical perspective and he is a patent co-author on a novel Foley catheter design.
Marc earned his B.S. in cell and developmental biology with honors at the University of California, Santa Barbara.