Director, Regulatory and Clinical Affairs
Ms. North joined Sedia Biosciences in September 2020 as Director, Regulatory and Clinical Affairs, and is responsible for leading the Regulatory and Clinical Trials operations for the company. Ms. North’s experience includes program and project management at ICON Plc (2019-2020), IQVIA MedTech (2017-2019), and Biotronik, Inc. (2009-2017) where she managed the project teams and clinical trial operations of global clinical research studies for companion diagnostics, in-vitro diagnostics, blood safety therapies, breast implant products and cardiology indications. Prior, Ms. North was at Hemcon Medical Technologies as Vice President, Clinical Trials (2006-2008), where she was responsible for the development of the clinical strategies and operationalization of the company’s clinical research programs. As Director of Clinical Affairs for Calypte Biomedical (2004-2006), Ms. North coordinated the conduct of international product evaluations within industry and NGO programs within key African and Asian countries and was responsible for the regulatory submissions that led to product approvals within the strategic countries of interest. Her early career was at OraSure Technologies (1991 – 2004) in various roles within R&D and Clinical Research, where she was a key leader during the clinical development programs for the company’s oral fluid diagnostics, and acted as primary company liaison to the Centers for Disease Control and Prevention during the product launch of the company’s HIV rapid test technologies and implementation within US Public Health Laboratories. Ms. North holds a B.S. degree from Humboldt State University in Molecular and Cellular Biology. She has achieved PMP certification (Project Management Institute) and CCRP certification through Society of Clinical Research Professionals (SOCRA).