Clinical Diagnostic Assay Development Consultant (224605)
Life Sciences & Technology
| Clinical Research & Clinical Affairs
A BDN client is looking for a senior-level consultant to work on creating the regulatory roadmap and help design a clinical diagnostic assay that will be used for screening patients enrolled in a clinical study for the client’s Oncology therapies. The consultant will need to help to draft the regulatory roadmap for a companion diagnostic assay from R&D through to FDA approval. The candidate will also work on design/development of the diagnostic assay (immunohistochemistry/IHC method), performing risk assessment for patients screened for the study, filing the IDE, working with/selecting 3rd party to make the assay, developing screening protocol and providing insight on putting together the kits. The consultant will need to have sufficient IVD experience, have previous experience with developing clinical assays for companion diagnostics for predictive biomarkers, experience with regulatory strategy development, IDE filing, and preferably Oncology therapy experience.