Working closely with In Vivo Pharmacology lead, project leads and internal scientists, you will understand the scientific question each in vivo study is designed to answer and the decision it is intended to support. Scientific strategy and major design choices will be agreed collaboratively; you will take ownership of translating those decisions into robust, executable CRO studies and driving day-to-day delivery from protocol development through data review and reporting.
What you'll do
Understand the science and operationalise agreed study designs
- Work with internal project leads and scientists to understand the underlying biological question, study objectives, key readouts and intended decision-making value of each study
- Translate agreed study concepts into clear, executable CRO study plans covering model set-up, groups and controls, dosing, endpoints, sampling, tissue allocation, downstream readouts and timelines
- Critically review CRO proposals, protocols and amendments for scientific coherence, practical feasibility and alignment with the agreed study objective; challenge ambiguities or inconsistencies and escalate changes that could affect interpretation
- Act as the primary day-to-day scientific contact for CRO partners conducting in vivo studies on Engitix's behalf
- Support study scoping, vendor evaluation and selection, quotations/SOWs and protocol finalisation, then coordinate kick-off, test-article and sample logistics, in-life communication, terminal collections, data transfer and reporting
- Manage multiple concurrent studies, dependencies, timelines and deliverables; resolve operational issues where possible and flag material scientific, logistical or schedule risks early
- Review CRO study updates, amendments, deviations, sampling plans and practical constraints throughout execution, checking them against the protocol and scientific objective
- Review interim and final data for completeness, protocol consistency, data quality and biological plausibility; identify discrepancies and work with internal and CRO scientists to determine whether issues are technical, executional or biological
- Communicate concise study status, results, deviations, risks and unresolved issues to In Vivo Pharmacology lead, project leads and senior stakeholders, escalating promptly when scientific interpretation or programme-level decisions are required
- Maintain complete, accurate and traceable study records, including ELN entries, protocols and amendments, study schedules, material and sample logistics, key decisions and communications, data packages, QC reviews and final reports
- Ensure outsourced studies are delivered to high standards of scientific rigour, animal welfare, data integrity and applicable regulatory requirements
- Identify opportunities to improve CRO ways of working, study execution, operational efficiency and data quality across the in vivo portfolio
