ApconiX Welcomes Stephen Kirk
ApconiX is delighted to welcome Stephen Kirk who joins us as a Consultant in Nonclinical Safety and Regulatory Strategy and will be working with Dr. Richard Knight, director and co-founder of ApconiX.
Career
Stephen is an immunologist by training, having completed his degree before entering the drug development space. His early career included roles at Inveresk (now part of Charles River) in Edinburgh, where he gained experience across a wide range of toxicology studies involving new chemical entities, oligonucleotides, biotherapeutics, gene therapies, and cell therapies. In 2000 he moved to CTBR (now Charles River) in Montreal, Canada, where he worked with large pharmaceutical companies to develop immunology assays for the recently introduced ICH S8 guidance. Stephen became increasingly involved in the in-vivo toxicology side, running immunology studies as a study director.
Returning to the UK in 2006, Stephen joined Aptuit, in Edinburgh, as a study director, working across a wide range of toxicology studies involving new chemical entities, oligonucleotides, biotherapeutics, gene therapies, and cell therapies. In 2009, Stephen joined Covance (now Labcorp) in Harrogate. As a toxicology studies director and immunotoxicologist specialist, he ran toxicology studies and provided immunology interepretation. When a specific department for Immunology and Immunotoxicology was created he developed interests in vaccines, antibodies, immunomodulating small molecules and more, and served as Interim Global Lead of Immunology/Immunotoxicology. His responsibilities included the rollout of global protocols and procedures for multiple immunology assays across several sites, as well as developing and managing annual budgets and business development strategies to ensure sustained growth of the group. During his time at Covance, Stephen earned a post-graduate Certificate in Biopharmaceutical Drug Development from the University of Leeds, covering the full drug development spectrum from discovery through to manufacturing development and regulatory submissions. He also worked as a subject matter expert, advising clients on study design and helping them satisfy specific country regulations.
After ten years at Covance, Stephen moved to KalVista Pharmaceuticals and later to Allergy Therapeutics, where he held senior positions, designing nonclinical safety strategies for candidates at various stages of development, as well as authoring of regulatory documents for agency submissions. Recognizing a need to further develop his regulatory expertise, he joined Scendea as a consultant, focusing on the preparation of regulatory submissions including IND, CTA, IB, ODD and PIP/PSP documentation, as well as reviewing nonclinical protocols and study reports.
Working with ApconiX
Stephen had been in touch with ApconiX in past roles and knew some of our team in his social circle. When he decided to become a freelance consultant at the start of 2026, he got in touch with Richard who brought him on board immediately.
With thirty years of experience in nonclinical drug development, Stephen offers services for design, oversight, and interpretation of nonclinical safety studies as well as a solid understanding of GLP’s and nonclinical CRO’s. He provides support for regulatory documentation including CTD Module 2, pre-IND, CTA, IB, ODD and PIP/PSP authoring, as well as identifying gaps in nonclinical safety packages and providing regulatory strategy advice.
Richard Knight commented: “Stephen’s knowledge and background as an immunologist and toxicologist will be a valuable addition to ApconiX consultancy team. He brings a lot of experience from varied roles within biotech, consultancy and CROs, and we are very much looking forward to working with him.”
Interests Outside of Work
Outside the office, Stephen enjoys staying active through running, swimming, and football. When asked if he’s training for a specific race, he laughed: “I think I’ve ticked a lot of the boxes already for marathons and other races, I’m just doing it for fun now.”
