The Expert: Kimberly Guedes, RN, BSN, MBA.
Kimberly Guedes is a seasoned professional with 30 years of experience in clinical development and operations, spanning pre-clinical, Phase I-IV trials, translational research, and multiple drug development disciplines. She has held various roles in organizations such as Yale University School of Medicine, Keiferx, Centrexion Therapeutics, Merck Pharmaceuticals, Bristol Myers-Squibb, and Mitsubishi Pharmaceuticals.
As a clinical development expert, Kim has directed cross-functional teams, successfully managed complex global regulatory projects, and led multimillion-dollar bids with pharmaceutical companies. Her leadership has resulted in launching research studies across the US, EU, South America, and PAC-Asia, as well as completing multiple phase III trials ahead of schedule during the pandemic.
Kim has a wide range of experience in new product development, process improvement initiatives, and portfolio and corporate integrations. Her clinical expertise includes managing clinical operations in start-up biotech and pharmaceutical companies, such as KeifeRx and Centrexion Therapeutics.
In her various roles, Kim has demonstrated global regulatory and quality product development leadership. She has been responsible for project management, timelines, and budgets for product portfolios, as well as implementing policies, processes, and tools needed to optimize project execution.
Kim has also worked in the CRO sector, supporting clinical trials in project management, operations, feasibility, and investigator start-up initiatives. Her diverse experience in roles from Clinical Research Associate to CEO enables her to provide valuable insights across commercial, marketing, patient recruitment, and retention aspects of the industry.
As a regular presenter at professional conferences, Kim is an active member of the Alzheimer's Executive Leadership Committee for the Ride to End Alz. She holds an MBA from The University of Dayton, a BS in Nursing from Salve Regina University, and is audit-certified through Barnett International. Kim was awarded the Carolyn E. Green Scholarship for leadership opportunities for women in the life sciences industry.
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