Patti Connolly, MS
Director of Clinical Services
Patti Connolly serves as the Director of Clinical Services for Pearl Pathways. She has over 30 years of experience in medical research across academic and industry settings with over 10 years focused on product development, clinical research, and regulatory affairs. Her leadership as the director of projects led to the development of multiple in vitro diagnostic products. Patti’s extensive experience includes managing successful design development projects, clinical trials design, protocol and budget development, contract negotiation, IRB submissions, site monitoring, auditing, and study close out. She directed domestic and international regulatory affairs initiatives and maintains a track record of accelerating novel product realization by formulating clinical research and regulatory submissions strategies. Patti has also participated in ISO 13485 audits and led interactions with the FDA.
Prior to joining Pearl Pathways, Patti was a founding member of a high-growth company involved in the development of innovative diagnostic test system technologies for infectious diseases. Patti bolstered growth of the company from a start-up concept to an established, profitable life sciences organization. She enhanced the company’s data analytics capabilities, spearheaded risk management strategies, developed bench strength by augmenting staff engagement through capability building, and directed projects leading to the development of multiple in vitro diagnostic products.
Patti is an accomplished microbiologist with extensive experience in biocontainment, serving several years as the Responsible Official in the CDC Select Agent Program. Patti is a persuasive writer and influential communicator, able to synthesize complex technical materials. She has authored over 60 manuscripts published in peer-reviewed journals as well as presented at numerous scientific meetings.
Patti is experienced at developing and managing budgets, defining and reaching performance objectives. She applies a team-focused, winning leadership style and has successfully assembled and led several cross functional teams. Patti earned a B.S. in Microbiology and an M.S. in Pathology and Laboratory Medicine from Indiana University before completing the graduate certificate program in Medical Device Leadership from Xavier University.