Director of Biometrics, Corcept Therapeutics
Julia A. Varshavsky, Ph.D. is a strategic leader with 15 years of drug development experience spanning areas of drug discovery, Phase I-IV development, commercialization, life-cycle management and business development. Her therapeutic area expertise includes orphan and non-orphan indications across many therapeutic including endocrinology, asthma, allergy, inflammatory bowel disease, critical care, oncology, and sleep and movement disorders.
In her current role at Corcept Therapeutics, Dr. Varshavsky is responsible for building and executing the vision for systems, processes and staffing for Biostatistics, Statistical Programming and Data Management, including optimization and management of data capture systems, and data analytics framework in support of the Corcept portfolio.
During her tenure, Dr. Varshavsky served in a variety of leadership roles across drug discovery to late stage development in both large R&D settings (Eli Lilly and Company, Genentech) and small-to-midsize pharma (Jazz Pharmaceutical, Corcept Therapeutics). As a development team leader, Dr. Varshavsky led cross-functional teams towards key deliverables such as clinical development plans, BLAs, NDAs, and regulatory response. She has successfully negotiated statistical design and analysis approaches with the FDA and EMEA in late stage development, as well as post-marketing commitment settings. Her work in drug discovery contributed to discovery, validation and utilization of compound-specific methods for identification of genetic and protein predictors of clinical safety and efficacy. As a due-diligence team member, she contributed to the assessment of probability of technical success of clinical components of a US submission dossier with an impact on deal structure and timing.
In her roles as a functional manager and clinical development partner, Dr. Varshavsky had an opportunity to mentor and coach many colleagues on drug development strategies and execution, and led corporate initiatives to increase efficiency of drug development processes. She has also served as an industry representative on professional committees resulting in an increased collaboration between pharma industry and academia via enhancement of academic curriculum and design of corporate internship programs.
Dr. Varshavsky holds a Ph.D. in Statistics from Purdue University where she worked under the advisorship of Professor James. O. Berger. She has published and presented in the fields of theoretical and applied Bayesian statistics as well as methodological approaches to clinical trial design optimization and analysis.