Brian Barnes

Director, Governance Excellence & Risk Management
BioNTech
 

Brian Barnes is a clinical development and quality leader at BioNTech, where he leads Governance & Risk Management within Global Development Excellence. With more than 20 years of experience across sponsor, CRO, and clinical technology organizations, he specializes in risk-based quality management and the practical, compliant application of AI in regulated clinical development. Brian leads cross-functional initiatives that embed risk-based approaches into trial execution and strengthen the quality and traceability of operational decision-making. He also contributes to industry working groups, regulatory engagement, and publications advancing risk-based monitoring and quality oversight in clinical trials.

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