Joel Bercu, PhD

Gilead Sciences Inc
Director, Nonclinical Saftey and Pathobiology
Dr. Joel Bercu PhD, MPH, DABT is a Director in the Nonclinical Safety and Pathobiology group at Gilead Science and has 18 years of public health / toxicology experience in pharmaceuticals. His mission while at these positions is to protect the safety of staff, patients, and the environment. He leads the Environmental and Occupational Toxicology (EOT) group at Gilead. The EOT group provides expert toxicological documentation for occupational health categorizations / occupational exposure limits, permitted / acceptable daily exposures for cleaning validation, environmental risk assessments, pharmaceutical impurity assessments (including mutagenic / carcinogenic impurities), QSAR assessments of impurities for ICH M7 compliance, deviations, leachables and extractables and excipients. The EOT group is also responsible for monitoring and reviewing toxicology tests including ecotoxicology, mutagenicity testing for impurities, and worker safety testing. Prior to joining Gilead Sciences he has worked at Eli Lilly and Amgen. He is a member of the Society of Toxicology and the Risk Assessment, Occupational and Public Health (where he served as President), and Medical Devices specialty sections. He is a part of the Occupational Alliance for Risk Science – Workplace Environmental Exposure Level (OARS-WEEL) committee and an active member of the Occupational Toxicology Roundtable. He has had several external collaborations to influence regulatory guidances such as chairing the Risk Assessment sub-section for ICH M7 and is developing its corresponding Addendum. He has served on International and Environmental Life Sciences Institute, Health and Environmental Sciences Institute (ILSI HESI) committees to advance risk assessment methodology. He received his BS from Texas A&M University, MPH from University of Texas – Houston School of Public Health, PhD from Indiana University, and is a Diplomate of the American Board of Toxicology (DABT). He continues to publish and present at national meetings in the field of toxicology with a focus on public health and risk assessment.