Performance-driven clinical strategist and researcher for medical device, biologic, and combination products. Combines extensive medical product experience, healthcare administration background, and nursing expertise to bring a unique perspective to corporate, clinical and regulatory strategic planning, marketing, project management, team development, problem solving, staff motivation/cooperation and interdisciplinary communication. Committed to excellence in corporate strategy, clinical development program design, and team success. A dynamic and successful leader of highly effective and engaged physician advisors, clinical departments, and multidisciplinary teams. Demonstrated expertise in the strategic design and development of innovative and successful trial designs including global IDE/IND trial approvals. Extensive global regulatory experiences, including verbal and written communications and in-person meetings with FDA, Health Canada, Notified Bodies, and the Therapeutic Goods Administration (Australia). Obtained FDA Orphan Drug, Fast Track, and Breakthrough Therapy designations for a novel microbiota-based drug. Expertise in the development of marketing and communications strategy and tactics for corporate, clinical, and regulatory success. Strong, demonstrated marketing and business development skills. Extensive experience with cardiovascular, neuromodulation, spinal/orthopedic, ophthalmic, gastrointestinal, urinary and infectious diseases products. Highly regarded speaker, trainer, and mentor. Developed numerous innovative and successful marketing, sales, and clinician training programs and materials.
Registered Nurse, State of Minnesota, current.
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