Karthi Natarajan joined COUR in 2024 as Head of Clinical Operations, overseeing the implementation and execution of all clinical trials.
With over 25 years of experience in clinical trial operations and pharmaceutical development, Karthi has been instrumental in IND, NDA, and sNDA submissions, including Addyi, the first FDA-approved treatment for female sexual dysfunction. He led development and execution of a Phase 1 driving simulator protocol that is the framework for FDA guidance on assessing drug impairment. He was also the clinical trial lead for global Phase 3 studies in metastatic melanoma and breast cancer. Karthi also supported the due diligence, acquisition, and development of over 12 products, including assets in oncology, women’s health, and rare disease treatments.
Before joining COUR, Karthi was Senior Director of Clinical Development at Macro Biologics from 2022 to 2024, where he led clinical strategy and development of novel topical antimicrobials for surgery and trauma. His clinical experience started as a Project Manager at Rho, Inc. (2000-2005), progressing through roles such as Clinical Trials Manager at Abraxis BioScience (2008-2011), Director, Clinical Affairs at Sprout Pharmaceuticals (2012-2015), Director, Clinical Operations at Roivant Sciences in 2016, and President at Lozob Consulting, LLC (2019-2021).
Karthi has a deep passion for clinical research and enjoys the challenges of navigating the drug development process to generate the highest quality data from clinical trials.
He earned his BSPH and MPH in Biostatistics from the University of North Carolina at Chapel Hill’s Gillings School of Global Public Health.