Senior Nonclinical Development Manager

Senior Nonclinical Development Manager Cycle Company: Cycle Pharmaceuticals Ltd Position Summary: This full-time position is within the Research and Development department in our Cambridge office on a hybrid basis (minimum 3 days in the office). We’re expanding our Research and Development team and recruiting for a Senior Nonclinical Development Manager to lead nonclinical and translational science across our development portfolio, helping turn promising science into robust development strategies for patients living with rare and complex diseases. In this role, you’ll take ownership of nonclinical study design, oversight and interpretation, spanning pharmacology, disease models and GLP toxicology. Working across programmes in metabolic disease, neurology, immunology and oncology. You’ll ensure nonclinical development packages are scientifically rigorous, strategically aligned and designed to meet FDA expectations. From new molecular entities to reformulation programmes under the 505(b)(2) regulatory pathway, you’ll work closely with both internal teams and external experts to generate meaningful evidence, manage specialist CROs and bioanalytical partners, and translate study findings into clear recommendations that inform clinical development. If you’re a nonclinical scientist who thrives on solving complex scientific challenges, brings strong study design and CRO management experience, and wants to see the impact of your work across the development journey, we’d love to hear from you. Our Company At Cycle, we believe that Every Single Patient Matters . This is at the heart of why we work and were looking for people to join our team who share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen. Our growing portfolio now covers oncology, haematology, neurology and rare metabolic genetic conditions where we improve existing drugs, repurpose them for new uses and bring generics back to market. Using cutting-edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice. Headquartered in Cambridge, UK, with a significant US presence, Cycle has scaled rapidly and was named one of the UK’s fastest-growing private companies by The Sunday Times (Sunday Times 100 2024 & Sunday Times 100 Tech 2025). If you want to know more about what we do then, why not check out our website and take a look at some of our patient stories: Patient Stories - Cycle Pharma What you’ll be doing in this role: • Lead the design, placement, oversight and interpretation of pharmacology, proof-of-concept, PK/TK, ADME and GLP/non-GLP toxicology studies, including safety pharmacology, genotoxicity, reproductive toxicology and juvenile animal studies. • Develop integrated nonclinical development plans aligned with clinical and regulatory strategies, identifying data gaps and defining study requirements in collaboration with Regulatory Affairs, including bridging strategies for reformulation programmes. • Select and manage nonclinical CROs, bioanalytical laboratories and consultant toxicologists, overseeing study protocols, interim data, reports, timelines, budgets and issue resolution; act as sponsor representative for GLP studies where required. • Ensure studies meet applicable GLP requirements, relevant ICH guidelines and regulatory expectations, while upholding high standards of animal welfare and the principles of Replacement, Reduction and Refinement (3Rs). • Interpret nonclinical findings to inform clinical development, including NOAELs, safety margins, exposure limits, starting doses and dose escalation, working closely with Clinical Development. • Define translational hypotheses and b