Abhi V.
Senior Director, Clinical Science @Apellis Pharmaceuticals
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WORK HISTORY
Senior Director, Clinical Science @Apellis Pharmaceuticals
Boston, MA, US
Clinical development lead for ophthalmology programs, overseeing clinical scientists and medical monitors across global Phase 1–3b trials in GA.Directed regulatory submissions worldwide as in-house scientific expert, ensuring alignment with diverse regulatory requirements.Guided development of TPPs, GDPs, CDPs, and study designs across cross-functional teams (CMC, translational, commercial, medical).Pioneered AI-based biomarkers and novel clinical endpoints to enhance diagnostic and therapeutic precision.Built and managed global scientific advisory boards; led publication strategy, podium presentations, and data communications.Oversaw budgets, timelines and execution in collaboration with internal/external stakeholders.
EDUCATION
Elite School of Optometry, BITS
BS, Optometry
University of Houston
PhD, Physiological Optics and Vision Science
ABOUT ABHI V.
Clinical development executive with 15+ years of leadership experience across pharmaceutical and medical device organizations, advancing assets from early research through global market approval. I specialize in ophthalmology—retina, glaucoma, presbyopia, IOLs and ocular imaging—and bring a unique blend of scientific, clinical, regulatory and medical affairs expertise.Experienced global clinical development leader across Phase 1, 2, 3b and extension trials. I am recognized for spearheading innovative clinical biomarkers and AI-driven endpoints, guiding regulatory submissions across multiple international agencies, and driving cross-functional alignment across CMC, translational, clinical, commercial, and medical teams.My career spans R&D, translational science, clinical operations, regulatory strategy, product development and post-market programs. I have built and led clinical organizations, managed multimillion-dollar budgets, developed global development plans and collaborated with KOLs worldwide. Passionate about advancing eye care, I thrive at the intersection of innovation, clinical execution and strategic decision-making.
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