Precision Medicine, CDx & Design Control Execution

" Lead end to end program management for CLIA based diagnostic initiatives, including IUO assay design and development, analytical verification, assay transfer, and CLIA validation.

" Drive Design Control rigor across design inputs/outputs, risk management, traceability, design reviews, and Design History File (DHF) readiness in alignment with established TM QMS.

" Partner with Pathology/IHC, Molecular Diagnostics, Device Quality, Regulatory Affairs, and Lab Compliance to ensure compliant and timely clinical enablement.

" Integrate diagnostic strategies into clinical protocols to support patient stratification and early development decision making.



Bioanalysis Program Management (GLP)

" Coordinate GLP compliant bioanalytical programs (PK/PD/ADA) supporting clinical studies, including oversight of assay timelines, critical reagents, data transfers, a...