Dynamic global clinical research and regulatory subject matter expert with 20+ years of experience and a history of optimizing regulatory compliance with process improvements and cost control. Proactive leader with proven ability to build business relationships and translate complex, technical concepts into accessible terms. Excellent critical thinking, research, contract negotiation, legal analysis, and writing skills.
Responsible for North American Operations of a global full-service CRO: P/L, legal, regulatory, quality assurance, audit, inspection support, business operations and development, resourcing, talent recruitment/retention/development, and client satisfaction. Coverage includes Canada, Mexico and Puerto Rico. Provide for FDA submisisons and negotiations on a client's behalf.
Key indications: oncology, pain, respiratory, immunotherapy, central nervous system, psychiatry, women's health, surgery, precision medicine, endocrinology, regenerative medicine, dermatology...and rescue trials. Co-developing programs for EMR-EDC interoperability initiatives that will forever change the acceleration of research and reduce costs for Sponsors.
Founder of SCOPE Academy Workshop Series offered FREE to the public interested in learning about the development of a medical product under specific regulatory, clinical research and marketing perspectives.
Executive representative of CRO provider for Shifield International Group bridging Chinese FDI into the US.
With low attrition rates (less than 5%), especially against the typical CRO (25+%), SCOPE has a phenomenal business culture that prioritizes both clients and employees. Learn why and how SCOPE should be your strategic partner in research!