Home » Clinical Development Lead
- June 15, 2018
Based from offices in London, Stevenage & Edinburgh, LifeArc is a medical research charity which helps academic researchers and life science organisations turn their research into patient centred treatments & diagnostics. LifeArc lowers the economic hurdles which might have otherwise prevented research being developed & validated to have viable commercial medical applications.
LifeArc’s Centre for Diagnostics Development (CDD) helps develop early stage diagnostic opportunities through to clinical evaluation, with a view to creating long term commercial opportunities with patient benefit. LifeArc is looking to appoint a Clinical Development Lead to the CDD to define and implement CDD’s clinical development strategy, as well create technical documents for regulatory submissions and international registration. The Clinical Development Lead will be based out of LifeArc’s CDD at Edinburgh BioQuarter, which is a purpose-built hub for some of Scotland’s most innovative life science companies.
The role is integral to the CDD’s ability to deliver clinical performance evaluation data to their industrial collaborator or regulatory body. The Clinical Development Lead will define the CDD’s clinical development strategy in collaboration with the project development team and from this design, implement and monitor the requisite clinical studies of new and modified in vitro diagnostic products; they will also lead in the preparation of regulatory submissions and international package registrations.
The Clinical Development Lead collaborates in the development of the scientific validity dossier and supports the development team with feasibility studies, including preparation of the clinical evidence dossier of the IVD product(s) in development.
This position requires a detailed understanding of the clinical laboratory and how it functions; experience or thorough understanding of assay and instrument principles involved in in vitro diagnostic product design and usage and in the scientific, statistical, regulatory and compliance requirements of clinical research is essential.
As such, we expect the successful candidate to have established a high degree of competence in clinical research and have experience in all aspects of a clinical research program and regulatory submissions. A strong communicator able to converse with both internal teams, external collaborators as well as individuals and groups at clinical sites.
We would also expect the successful candidate to have a background and degree in Biomedical Sciences, Biology or other Life Sciences, have experience in GCP and be a holder of a PhD or an MD. A high degree of accuracy & attention to detail in the preparation of written documents such as clinical protocols and regulatory submissions is essential.
Candidates should also be based within a commutable distance of Edinburgh or be willing to relocate for thes role.
Further information can be obtained by contacting Leah Ronaldson on 0131 539 7087 or by email via firstname.lastname@example.org which is also the address for applications.