Chief Operating Officer
Ioniq Sciences, Inc.
Built and advanced IONIQ Sciences as a leader in early cancer diagnostics by developing products, obtaining 17 Company patents, completing 7 clinical trials, obtaining regulatory approvals and quality certifications, setting up manufacturing and distribution and raising $40 million of investment. Managed over 100 Company staff, contractors and consultants including employees, clinical coordinators and monitors, regulatory and quality assurance consultants, customer, and technical support, mechanical, electrical, computer and bioengineers, biostatisticians, salesman, trainers, software developers, and physician investigators.Prepared business plans, slides budgets, financial projections, patents, private placement memorandums and SEC filings (Annual reports, Form 10-K and 10-Q’s,) and managed financial audits to grow Company. Managed and designed multisite clinical trials, trained staff, monitored and developed study protocols at centers including Mayo, Stanford, MD Anderson, Beth Israel, UCLA, HCA Healthcare, Huntsman Cancer Institute, Intermountain Healthcare, and centers in Italy, Germany, Switzerland, Mexico, and China. Obtained CE Mark (European medical device approval) and maintained approval for 10 years by developing regulatory documents, technical files, clinical evaluations, risk analysis, and managing quality and European auditsObtained US FDA Medical Device Breakthrough Designation, developed and authored FDA submissions including 510k’s, De Novo application (2,918-page submission), Covid-19 Emergency Use Authorization and Q-subs.Designed and implemented an ISO 13485 certified quality management system, set up manufacturing, established vendor relationships and implemented assembly and inspection processes in the US (SLC, UT) and China (Wuxi, Jiangsu province); ISO 13485 certification of quality management obtained and maintained for 10+ years. Reduced production costs by 50% by setting up in house manufacturing in lieu of outsourcing.
