Sally Dowen

WORK HISTORY

EDUCATION

ABOUT SALLY DOWEN

I’m an independent clinical trials consultant with over 20 years of comprehensive clinical trials experience from first concept to final reporting. My previous leadership roles include Head of Clinical Trials at the MHRA (the UK medicines regulator) and Director of Clinical Science and Regulatory Affairs at one of the UK\'s most respected early-phase CROs (with overall responsibility for Clinical Project Management, Regulatory Affairs, and Medical Writing). I’m a specialist in early phase development and have overseen more than 200 phase I and II trials across a diverse range of therapeutic areas including: CNS, dermatology, diabetes, endocrine, gastrointestinal, immunology, infectious diseases, pain, psychiatric, respiratory, and oncology. I have contributed to the design, regulatory strategy, management and reporting of many trial types, including: adaptive, multipart first-in-human trials, single ascending dose (SAD), multiple ascending dose (MAD), food effect, ethnicity bridging, bioequivalence and bioavailability, drug-drug interaction studies, ADME (absorption, distribution, metabolism, and excretion), thorough QT, PET, fMRI, trials involving patient and special populations, and trials of genetically modified organisms (GMO).My unique experience and clinical trials expertise combine regulatory rigor and scientific scrutiny, with trial logistics and problem solving, making me a valuable partner in achieving optimal trial outcomes. I’m a people-focused leader, who integrates seamlessly with client teams, fostering open communication and providing practical guidance. I’m Alternate Vice Chair of London–Brent Research Ethics Committee (flagged for review of clinical trials in children, phase 1 healthy volunteers, and gene therapy products), a member of the UK Health Research Authority’s Phase 1 Expert Advisory Group and the MHRA’s Phase 1 Stakeholder group, and a guest lecturer at King’s College London. I hold a BA in Natural Sciences (specialising in Cellular Pathology and Virology) and a PhD in Molecular Oncology from Cambridge University, and a Certificate in Human Pharmacology from the Royal College of Physicians.