Dr. Alex MacDonald is a quantitative clinical pharmacologist and Pharma industry veteran with experience across the Pharma/Biotech, consulting and government sectors. He joins Certara from the Specialist consultancy and CRO, Allucent, where was Senior Vice President of Model-Informed Drug Development (MIDD). He led a global team of pharmacometricians, PBPK and translational modelers, pharmacokineticists, and data programmers delivering quantitative clinical pharmacology consulting services to small and mid-size biotech and pharmaceutical companies.
Alex brings more than 25 years of experience in clinical pharmacology, pharmacokinetics, and modeling and simulation across the full drug development spectrum — from early discovery and translational science through late-stage regulatory submissions and post-marketing activities. Prior to joining Allucent, he held senior leadership roles at AstraZeneca and GlaxoSmithKline. At AstraZeneca, as Executive Director and Global Head of Respiratory and Immunology Clinical Pharmacology and Pharmacometrics, he led the clinical pharmacology and MIDD strategy for a broad R&I portfolio, contributing to the successful global approvals of anifrolumab in systemic lupus erythematosus, tezepelumab in severe asthma, nirsevimab for RSV infection in pre-term infants as well as significant life cycle progression of AZ’s inhaled product portfolio. At GSK, he served as Senior Director and Head of Immuno-Inflammation Clinical Pharmacology, with accountability across rheumatology, gastroenterology, and autoimmune disease programmes, contributing to the successful global approval of belimumab (Benlysta) in systemic lupus erythematosus. Earlier in his career, he held positions at F. Hoffmann-La Roche and Novartis Pharma, developing expertise in PBPK and translational PK/PD modeling across cardiovascular, metabolic, respiratory, and dermatology disease areas. As a government scientist with UK’s Health and Safety Executive, Alex provided PBPK expertise for industrial product toxicology risk assessment and approval.
Dr. MacDonald holds a Ph.D. in Physiologically-Based Pharmacokinetic Modeling from the University of Sheffield, supervised by Professor G.T. Tucker, a co-founder of Simcyp, an MSc (Eng) in Control Systems Engineering, also from Sheffield, and a BEng (Hons) in Electrical and Electronic Engineering from the University of Bradford. He has over 30 publications and peer-reviewed articles in scientific journals, acts as reviewer for multiple journals and was on the organizing committee for the leading UK PK/PD modelling conference, PK UK.
