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Areas of expertise: Clinical Development and Operations; Phase I-IV Clinical trials, Pre-clinical, Translational Medicine, Quality, Global Regulatory, CMC, Commercial Product Development; packaging
Kim is an experienced clinical development and operations professional. Her entrepreneurial approach is informed by 30 years across multiple areas of drug development; operations,and project management, including pre-clinical, Phase I-IV, and translational research trials. From Neurology-Neurosurgery RN to Clinical Research Coordinator at Yale University School of Medicine to Vice President of Global Clinical Operations at pharmaceutical, start-up biotech companies and CROs including Keiferx, Centrexion Therapeutics, Merck Pharmaceuticals, Bristol Myers-Squibb, and Mitsubishi Pharmaceuticals
Kim has experience working alongside executive leadership to direct cross-functional teams of subject matter experts and has established herself as a subject matter expert in complex global regulatory, clinical development, and operations. Her leadership and engaging interpersonal style have delivered multimillion-dollar bids with pharmaceutical companies, global research studies launched in the US, EU, South America, and PAC-Asia, as well as multiple, sequential, phase III trials achieved ahead of schedule, during the pandemic.
She has led teams in the completion of a wide range of projects, including new product development, process improvement initiatives, and portfolio and corporate integrations.
Kim’s clinical expertise spans several areas, including leading the clinical operations of start- up biotech and pharmaceutical companies. As a member of KeifeRx’s Clinical Operations team, Kim conducted a GAP Risk & Clinical Trial Analysis designed to inform Senior leadership and the board of directors of any global or regional changes in the therapeutic, regulatory, CMC and financial landscapes that would affect the startup and completion of a Phase III Alzheimer’s trial, while enhancing comprehensive project quality, ICH E6 R3 compliance, and a Diversity, Equity and Inclusion plan.
Kim also oversaw and was a hands- on clinical operations executive member at Centrexion Therapeutics, where she led the completion and closed out three phase three pivotal trials during the pandemic.
Kim has demonstrated a breadth of global regulatory and quality product development leadership. She implemented and managed the planning, timelines, and budget for Centrexion’s product portfolio of priority non-opioid injectable pain therapies. She established the policies, processes, enterprise-wide tools, and training needed to optimize the management and execution of projects ranging from IND enabling, Translational , Phase I-III trials, through NDA preparation , including FDA inspection readiness preparation.
To immerse herself more deeply in every dimension of biopharmaceutical endeavors, Kim spent several years in the CRO sector supporting clinical trials in project management, operations, feasibility, and investigator start up initiatives at INC.(Syneos), Clinsys Clinical Research and QED Pharmaceuticals.
Kim provides insight gained from her experience leading teams with roles ranging from Clinical Research Associate to CEO; and representing a multitude of operational disciplines worldwide. Kim’s experience in developing and leading project initiatives – from pre-clinical to NDA– for clients across commercial/marketing, patient recruitment/retention, startup biotechnology to large global pharmaceutical companies.
Kim is a regular presenter at professional conferences and is part of the Alzheimer’s Executive Leadership Committee for the Ride to End Alz. Kim received her MBA from The University of Dayton, OH, and her BS in Nursing from Salve Regina University. Kim is also audit-certified through Barnett International and was awarded the Carolyn E. Green Scholarship dedicated to leadership opportunities for women in the life sciences industry.