Nilay C. Shah, MBBS (MD), is a physician–executive and global clinical operations leader with more than two decades of experience advancing therapeutic development, regulatory strategy, and commercial growth across the biotech and CRO sectors. He currently serves as Senior Vice President and Global Head of Ophthalmology at Emmes, where he leads the company’s fastest-growing therapeutic division and serves on the Executive Management Committee, reporting directly to the Chairman and CEO.
Over a 19-year tenure at Emmes, Dr. Shah has played a central role in scaling the organization from a 125-person firm to a global CRO with more than 1,400 employees. He has led complex, multi-phase clinical trials across ophthalmology, dermatology, neurology, endocrinology, rare disease, and other therapeutic areas. His leadership includes oversight of a Phase III trial supporting market authorization of a novel anti-CD6 monoclonal antibody and direction of the clinical program for the first autonomous AI system to receive FDA approval for the detection of diabetic retinopathy.
In addition to his operational leadership, Dr. Shah has built and retained high-performing global teams, created Emmes’ first pharmacovigilance department, and driven strategic alliances and commercial transformation initiatives that strengthened the organization’s position as a global partner to emerging and mid-size biotech companies.
Dr. Shah has long been active in Maryland’s innovation ecosystem. He serves as an advisor and reviewer for multiple TEDCO venture programs and is a Board Member of the Baltimore Innovation Initiative, supporting early-stage companies as they navigate regulatory pathways and commercialization strategy.
He earned his M.B.B.S. from the University of Mumbai and completed clinical training at the University of Pennsylvania, Robert Wood Johnson Hospital, and University of Mumbai Teaching Hospitals. He maintains certifications in Good Clinical Practice and NIH Clinical Research and is an active member of leading professional organizations in ophthalmology, drug development, and biotechnology.



