As the VP of Research and Clinical Affairs, I am responsible for both US IDE studies as well as OUS data collections on our products. I oversee the coordination of all clinical trials, vendors, budgeting and publication of data resulting from the trials. I am also responsible, as part of the senior management team, for the strategic development of the clinical program.

During my tenure at Orthofix, Inc., a medical device company, I held consecutive roles of increasing responsibility. In my current role, I oversee Clinical Affairs operations and led the restructure of Clinical Research Department. I direct corporate strategy for product development in collaboration with the executive team – define policies and protocols for clinical study implementation (IDE, post-market, and retrospective), identify surgeon partners, oversee clinical trials, develop departmental SOPs, and assure all deliverables are on time and within budget. Additionally, I recruit, train, and manage multidisciplinary teams of CRAs, biostatisticians, clinical consultants, and data managers. I foster collaborative relationships with internal and external business partners to meet organizational objectives – coordinate with legal team to ensure regulatory compliance, provide technical expertise and investigator brochures for Sales/Marketing, and oversee relationships with CROs and vendors. Some of my contributions include:-- Increased sponsor-site recruitment by 1.5 times with new digital recruitment tools, in-person qualifications, and IDE trial site qualifications initiatives.-- Oversee corporate publication strategy for clinical trial results including articles in peer-reviewed journals and white papers, deliver regulatory reporting, and present research to diverse audiences.

In the role of Clinical Research Director, I developed a full-scale clinical trials program for medical device company. I managed day-to-day operations of clinical research trials – directed protocol development, site selection, monitoring, data collection, and budget oversight. Also, I designed and initiated post-market clinical trials on existing products and delivered post-approval studies for Mobi-C motion-preserving disc. One of my contributions include:-- Established company-wide clinical research program – directed numerous managed studies, cultivated high-performance research staff, and wrote and initiated four protocols to collect real world evidence (RWE) on existing products.

I earned several promotions within the clinical research team during my tenure at DJO Surgical, a medical device company. In my most recent position as Director, I led the clinical research team and oversaw department operations. I established protocols, developed post-approval clinical research trials for surgical and recovery sciences product lines, recruited surgeons, and monitored and cleaned up three IDE studies. Additionally, I implemented talent acquisition strategies and facilitated training initiatives. Some of my contributions include:-- Delivered annual FDA progress reports and created multiple white papers and clinical research papers.-- Designed and initiated a mandated 522 order.

Lead study coordinator on several IDE osteoporosis and lupus trials as well as a very large shoulder study.