Stephen Kirk is a highly experienced Senior Preclinical Consultant with over 30 years in nonclinical drug development. Holding an M.Sc. in Biopharmaceutical Drug Development from the University of Leeds, he specialises in toxicology, immunology, and regulatory strategy, with deep expertise across biologics, vaccines, and small molecules.
Stephen has built his career guiding complex drug development programmes from early-stage research through to first-in-human clinical trials. His core speciality lies in designing, implementing, and interpreting nonclinical safety study packages, with particular strength in immunotoxicology. This is including assay development and validation in line with ICH S8 guidance.
His career spans senior roles at several prominent organisations. At Allergy Therapeutics, he led a successful IND submission for a novel peanut allergy vaccine. At KalVista Pharmaceuticals, he managed FDA relations and delivered regulatory documentation across Phase 1 and 2 trials. His decade at Covance/Labcorp saw him serve as Study Director and Principal Investigator, overseeing immunotoxicology, PK/PD, and biodistribution studies under FDA and OECD GLP guidelines. Most recently, as Principal Consultant at Scendea, he led regulatory submissions including IND, CTA, IB, ODD, and PIP/PSP filings for multiple clients.
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