Job Description
Pre-Clinical Development Lead
Permanent
Cheshire
SRG is delighted to be working with a seed-stage biotech to help them find a Pre-Clinical Research Lead. The organisation is developing a non-viral gene-delivery platform targeting glioblastoma cells and has shown incredibly positive results in pre-clinical models.
Reporting directly to the founders, you will be the operational engine that drives the platform from final GLP tox through first-patient-in. You will co-ordinate academics, CROs, manufacturing, vendors and regulators to drive this exciting project into clinic.
Key responsibilities:
* Project leadership to build and maintain the integrated project plan (timeline, budget, risk log) for GLP tox, CMC, regulatory and clinical work-streams.
* Regulatory operations – compile and submit CTA/IND, ethics track RFIs, manage agency correspondence (MHRA, FDA, EMA).
* Vendor & CRO management – source, contract, kick-off and oversee CROs and specialist labs; track KPIs and invoices.
* Study start-up – support protocol development, investigator brochure, site selection and green-light packages.
* Stakeholder communication – prepare dashboards and board packs; chair weekly cross-functional calls.