University of Colorado Anschutz Medical Campus

Department: Colorado Center for Personalized Medicine

Job Title: Lead Scientist, Functional Precision Medicine Initiative

Position: # 00803140 – Requisition #: 40294

Job Summary:

We are recruiting a Lead Scientist for the Functional Precision Medicine Initiative to provide scientific, technical, and strategic leadership supporting the development, clinical translation, and growth of the Functional Precision Medicine Platform. This individual will lead assay innovation, quality system development, translational implementation, external partnerships, and platform expansion activities supporting the development of a Clinical Laboratory Improvement Amendments (CLIA)-ready functional precision medicine laboratory.

The Lead Scientist serves as the scientific lead for platform evolution and future clinical readiness, working closely with the Director of the Functional Precision Medicine Initiative, the Clinical Laboratory Improvement Amendments Director, quality and compliance personnel, external consultants, computational scientists, automation engineers, and external collaborators. This role partners closely with the Leading Scientist responsible for day-to-day laboratory operations, personnel management, and sample execution workflows.

Key Responsibilities:

Scientific Development and Clinical Translation (25%)

• Lead development, optimization, and deployment of next-generation organoid-based functional precision medicine assays, including mini-ring screening assays intended for future clinical implementation.

• Partner with the Director of the Functional Precision Medicine Initiative and the CLIA Director to establish scientific roadmaps for clinical translation, assay validation strategies, performance specifications, and clinical deployment plans.

• Design and execute analytical validation, reproducibility, bridging, and feasibility studies supporting future clinical implementation.

• Evaluate emerging technologies, biomarkers, and assay methodologies that may expand platform capabilities and clinical utility.

• Translate research workflows into scalable, standardized processes suitable for regulated laboratory environments.

Quality Systems, Compliance, and Regulatory Strategy (20%)

• Serve as scientific lead for development of assay-specific quality systems in partnership with CLIA leadership, quality and compliance personnel, and external consultants, supporting a CLIA and College of American Pathologists (CAP) compliant functional precision medicine laboratory.

• Develop assay validation strategies, quality control frameworks, acceptance criteria, trending approaches, and performance monitoring plans.

• Contribute to quality management system elements including standard operating procedures, controlled documentation, deviation tracking, corrective and preventive actions, and quality metrics.

• Support preparation of validation reports, technical documentation, audit mater