Sr Principal Scientist
Merck & Co, Inc.
Julia earned a Ph.D. in Epidemiology from Brown University in 2009 and has co-authored 22 peer-reviewed publications; she is first author on 6 of these manuscripts. She has 15 years of experience in the pharmaceutical industry and has worked at several large pharmaceutical companies including J&J and GSK, and is currently part of the Epidemiology group at Merck & Co., Inc. Julia routinely leads cross-functional study teams including members from various functional areas (medical affairs, clinical development, safety, regulatory) and has planned and led several large post authorization safety studies using prospective and retrospective data collection, as well as numerous natural history/disease understanding studies within real world databases. She supports a portfolio of assets in clinical development and has extensive experience in the use of RWE to support clinical trial design and regulatory decision making. Julia has considerable experience interacting with FDA and EMA concerning post authorization safety study design, labelling updates, pediatric investigational plans, and clinical trial design. For the past 2 years, Julia has been an integral part of the TransCelerate RWD Health Authority Engagement workstream and co-authored the resulting deliverable for member companies, ‘Preparing to Engage with Health Authorities on Real World Evidence for Medicines: A TransCelerate Perspective’ Real World Data - TransCelerate (transceleratebiopharmainc.com).
