Robert Clay

Robert (Bob) Clay serves as Global Regulatory Affairs Advisor for Vigeo Therapeutics, Inc. Bob has more than 30 years of experience in regulatory affairs across the globe and with a diverse range of therapeutic areas in products and devices. As Managing Director at Highbury Regulatory Science, he provides regulatory and drug development consultancy to a range of growing businesses and investors. His executive and in-the-trenches expertise include drug development, oncology, and infection, strategic thinking, and internal change management. As Vice President of Regulatory Affairs – Oncology and Infection at AstraZeneca, he directed the division’s global regulatory function, including development and marketed programs. This included achieving approvals for IRESSA in EU and CAPRELSA in the US/EU, as well as forging external partnerships, such as the acquisition of Novexel, licensing of ZINFORO from Forest, and approval of ZINFORO in the EU. Bob led the regulatory contribution to personalized healthcare and biomarkers; guided the development of global capability; and reviewed project strategies across multiple therapeutic areas.