- Clinical research leader with extensive experience with both site and sponsor activities- Versatile key contributor skilled in clinical, regulatory, product development, clinical marketing, and sales support aspects of the medical device industry- Significant business development experience (pre-diligence, due diligence, acquisitions, integrations)- Accomplished author and persuasive public speaker equally capable in both scientific and marketing/sales support scenarios- Expertise and relationships across multiple therapeutic areas: interventional pain, acute pain, orthopedics/sports medicine, cardiac electrophysiology, interventional cardiology, cardiothoracic surgery, neurosurgery, spine, vascular surgery, urology, facial plastics, enteral feeding, critical care, drug delivery, and wound care- Driving and delivering high level scientific communications across multiple specialties and therapeutic areas.- Designed and executed large, multicenter, randomized clinical trials in key therapeutic areas such as knee osteoarthritis, low back pain, cardiothroacic surgery, and cardiac arrhythmia.Specialties:- Strategic clinical affairs management- Pre-clinical, pre-market, feasibility/first-in-man, investigator-sponsored, & post-market studies- Key opinion leader relationship development- Clinical and scientific advisory boards- Writing for peer-reviewed publication- US regulatory activities (Q-Sub, IDE, IND, PMA, & 510(k) submissions, FDA communications, PMA panel meeting, drug/device combination products)- OUS regulatory activities (CE mark, Japanese PMDA, Clinical Evaluation Reports, EU MDR)- Due diligence evaluations for mergers & acquisitions (including integration)- Advertising & promotions- Clinical marketing / scientific communications- Basic biostatistical analysis- Robotics- Capital sales support- Business development- Start-Up's