This is a fully outsourced-delivery role: you won't be running studies at the bench yourself, but you'll be the scientific backbone that keeps every externally run study scientifically sound, on track and well documented.
Key Responsibilities
Understand the science and operationalize 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
Own day-to-day delivery of externally commissioned in vivo studies
- Act as the primary day-to-day scientific contact for CRO partners conducting in vivo studies on Aerska'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
Monitor study execution, quality and data
- 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 the in vivo pharmacology lead, project leads and senior stakeholders, escalating promptly when scientific interpretation or programme-level decisions are required
Maintain rigorous study documentation and ways of working
- 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
