Provide independent scientific and quality oversight for biomarker assay development, validation, implementation, and ongoing performance across multiple technology platforms.
Salary Range (annually) $128,600.00 - $210,000.00
- Provide independent scientific and quality oversight for biomarker assay development, validation, implementation, and ongoing performance across multiple technology platforms.
- Review and approve assay-development scopes of work, analytical validation plans, quality-monitoring plans, final validation reports, and biomarker analytical reports.
- Define fit-for-purpose validation strategies and design pilot studies to identify and control preanalytical variables that may affect assay performance.
- Partner with Global Clinical Operations and external laboratories to ensure assays are properly validated and implemented for clinical sample testing.
- Conduct technical assessments and site visits as needed to evaluate analytical performance, operational rigor, scientific quality, and readiness to meet clinical-study needs.
- Ph.D.
- M.D.
- or comparable advanced degree in a relevant scientific discipline