Searching for an individual to be responsible for the development and validation of FDA approved quantitative diagnostic immunohistochemical assays on HistoRx’s proprietary platform, including the design and execution of studies for demonstration of clinical utility. In vitro diagnostic assay development experience specifically coupled to an instrument is important. The role will involve extensive interaction with commercial laboratories, academic thought leaders, and vendors.  Requires a business-savvy scientist to develop and maintain productive and successful relationships with commercial partners.

This position will involve the commercial development of diagnostic assays involving both established and new biomarkers:

• Thoroughly understand the overall diagnostic development process with an eye towards timelines and regulatory requirements.
• Understand the current diagnostics marketplace and have the ability to develop a plan to drive adoption of HistoRx diagnostic assays at all levels.
• Understand the necessity and composition of clinical assays which may be required for the development of HistoRx diagnostic assays.
• Collaborate with external investigators to design and conduct studies to confirm relevant biomarkers and test initial field performance characteristics of prototype diagnostic assays.
• Collaborate with external investigators to design and conduct multi-site studies to validate clinical utility (sensitivity/specificity, predictive value, likelihood ratio, etc.) of commercial versions of diagnostic assays.
• Facilitate the transfer of diagnostic assays and the HistoRx clinical instrument to commercial reference laboratories.  Support installation, training and trouble shooting efforts as necessary.
• Support the transfer of the commercial reagent products to external manufacturers and support troubleshooting and investigation efforts with contract manufacturing organizations.
  

Ph.D. preferred in physical or biological science with 10+-15 years industry experience in development of in vitro diagnostic tests and conducting studies for testing and validation of diagnostic assays.  Familiarity with applicable regulations and experience with laboratory testing in a CLIA-certified clinical laboratory are desirable. Demonstrated ability to function in a hands-on position in a start-up environment, highly desirable.  Excellent written and verbal communication/presentation skills are essential. The incumbent must possess a proven track record of leadership and establishing strong relationships with others at all levels. Effective collaboration and influence skills, with a customer service focus, are required.