CK Group are recruiting for a Head of Research, to join a growing early-stage Biotechnology company based near Manchester on a permanent basis. This is fantastic opportunity for an experienced scientific leader with a proven life science background in early drug discovery and driving projects into First-in Human/ clinics.
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
Your Background:
* Degree qualified/ PhD (preferred) with working knowledge on oncology, liposomes or gene therapy
* Proven and successful Project Manager with experience of the drug development process and the needs for progressing a small molecule from lead optimisation to first-in-human/ phase I and onwards to clinical review.
* Experience with CTA or IND submission and tracking
* Familiar with GxP, ICH, and MHRA processes.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 161 053 in all correspondence.
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