Apsida Life Science is currently recruiting on-behalf one of the UK's most exciting clinical stage Biotech firms! This is an excellent opportunity to join a world class research team in a dynamic, expanding biotech company. Our client is focused on identifying and developing cancer treatments by exploiting novel targets, operating in a scientific area of high expectation following the success of PARP inhibitors in the clinic. Our client have three molecules in clinical development with further programs being progressed into the clinic!
The organisation are looking for someone to oversee their companion diagnostic strategy for its late and early-stage clinical oncology development programs. The successful candidate must possess an understanding of clinical biomarker development, the commercial testing landscape, and the global regulatory guidelines for companion diagnostic submissions.
Responsibilities
* Design clear strategic recommendations for incorporating innovative clinical testing and companion diagnostic development into patient selection trials incorporating scientific, regulatory, commercial and global considerations
* Collaborate with the Biology, Clinical Development and Regulatory functions to drive diagnostic and clinical testing strategy from candidate selection to Launch.
* Proactively manage diagnostic projects supporting their drug development programs; Effectively partner with external diagnostic manufacturers, laboratories and vendors to support delivery of diagnostic tools and strategies. Provide oversight and leadership of external relationships as needed
* Ensure the integration of clinical assays or IVDs into clinical trials including reviewing sections of clinical protocols, lab manuals and/or ICFs.
* Provide regulatory expertise to all programs, author key sections of regulatory documents involvement in regulatory interactions.
Experience
* Over 7 years of experience conceiving and executing diagnostic/companion diagnostic strategies toward regulatory approval.
* A strong track record of leadership and ability to think holistically and long-term across industry trends and issues.
* Demonstrated experience in the development of companion diagnostics, particularly immunohistochemistry and biomarker strategies, including in depth knowledge of biomarker-based indication selection, assay development, analytical validation, and clinical validation of companion diagnostics
If you are interested in learning more, please reach out to Ethan Cortese at Apsida Life Science:
Ethan.cortese@apsida.co.uk
www.apsida.co.uk
+44 (0) 203 854 4606
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK) & Boston (USA) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.