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Provides medical and scientific expertise on clinical safety across the full product lifecycle, with emphasis on evaluating safety data during clinical development and post-approval. Chairs the Safety Management Team, oversees signal detection, aggregate reports (DSURs, PSURs, RMPs) and regulatory responses, and sets safety strategy for global cross-functional development and post-marketing teams.
Maidenhead
Lead the computationally guided design of a lipid nanoparticle delivery platform, applying chemical and biophysical principles to optimise LNP composition and formulation. Use AI-enabled chemistry, cheminformatics, predictive models and molecular modelling to prioritise formulation components, working closely with the experimental team and founding team in a small start-up.
London
Design and build large-scale synthetic gene loci and transgenic platforms for antibody discovery, using CRISPR/Cas9, RMCE and site-specific integrases. Hands-on molecular biology including PCR, NGS, plasmid construction and flow-cytometric immunophenotyping, within a small multidisciplinary team working from dry-lab design to wet-lab validation.
Cambridge
Field-based role installing, maintaining and servicing nano-flow cytometry instruments at customer sites across the UK and Europe, plus remote phone and email troubleshooting of hardware, software and reagents. Involves preventative maintenance scheduling, service documentation, spare parts inventory and coordinating service contracts with the sales team, following training with senior technical staff.
Stevenage
Lead regulatory strategy for a cardiology device company expanding into the US, UK, EU and Middle East, owning FDA, CE and UKCA submissions from Class I to Class II/III. Drive an audit-ready QMS (ISO 13485, 21 CFR Part 820, ISO 14971) and advise senior leadership on regulation, quality and clinical governance, working directly with the FDA, MHRA and notified bodies.
Bluetree
Cambridge
Leads the full statistical contribution to a clinical development programme, defining statistical strategy and methodology for trial design, analysis and regulatory submissions. Represents Biostatistics in interactions with FDA, EMA and PMDA, manages CRO/FSP outsourcing, and provides thought partnership on innovative study design and Go-No Go criteria. Two positions available across multiple therapeutic areas.
Amsterdam, Netherlands
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