Global Head Clinical Pharmacology & Pharmacometrics
Johnson & Johnson
Daniele Ouellet, PhD, Vice President & Global Head of Clinical Pharmacology & Pharmacometrics (CPP) at Johnson & Johnson (J&J) leads a global team of clinical pharmacologists, pharmacometricians, and a Phase 1 Clinical Pharmacology Unit. Daniele has more than 30 years’ experience in the pharmaceutical industry and has been a champion of model informed drug development (MIDD) throughout her career. In her role at J&J, Daniele ensures that CPP provides clinical pharmacology and pharmacometric modeling expertise including Quantitative System Pharmacology (QSP) and Model Based Meta Analysis (MBMA). Her team supports end-to-end clinical drug development projects starting at first-in-human (FIH) up to registration and beyond,for for small molecules, monoclonal antibodies, and novel modalities across the portfolio. Daniele has a Bachelor’s degree in Pharmacy from the University of Montreal and graduated with a Master and PhD degrees from the University of North Carolina at Chapel Hill.
Daniele served on the Board of Directors of the American Society of Clinical Pharmacology and Therapeutics (ASCPT, 2021-2024), the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ, 2021-2023) and International Society of Pharmacometrics (ISoP, 2014-2017). She is a Fellow of ISoP (FISoP), was awarded the ISoP Leadership Award in November 2020, and is an Honorary Fellow of the American College of Clinical Pharmacology. Daniele has published more than 80 original articles, multiple abstracts, and chaired annual scientific meetings and various symposiums .
Saturday, May 31, 2025
8:30 AM - 3:00 PM East Coast USA Time