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The Role:
This is a key operational role, where you will be responsible for driving our clients oncology programme from final GLP tox through to a first-in-human Phase I trial. You will be main point of contact and take ownership for coordinating CROs, stakeholders, vendors, and regulators to drive this exciting project to clinic.
Responsibilities:
- Project leadership - build and maintain the integrated project plan for GLP tox, CMC, regulatory and clinical work-streams.
- Compile and submit CTA/IND, ethics track RFIs, manage agency correspondence (MHRA, FDA, EMA).
- Vendor & CRO management
- Support protocol development, investigator brochure, site selection
- Stakeholder engagement and management
- Degree qualified/ PhD (preferred) with working knowledge ononcology, liposomes or gene therapy
- Proven and successful Project Manager with wealth of experience coordinating or managing Phase I/II trials (CRO, biotech or NHS R&D)
- Experience with CTA or IND submission and tracking
- Familiar with GxP, ICH, and MHRA processes.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only) in all correspondence.
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