Wren Laboratories is seeking an experienced consultant with expertise in liquid biopsy machine learning (ML) and clinical diagnostic algorithm development to support blood-based transcriptomic molecular diagnostics utilization.

The ideal candidate will have experience developing, verifying, validating, and documenting ML-based clinical classification algorithms, including:

· Development and validation of clinical classification algorithms for molecular diagnostics, liquid biopsy, genomics, transcriptomics, or precision medicine applications

· Design and management of training, testing, and independent validation datasets

· Binary and multi-class predictive modeling

· Clinical cutoff determination and optimization

· Performance assessment (sensitivity, specificity, PPV, NPV, ROC/AUC, etc.)

· Analytical and clinical validation studies

· FDA, CLIA, CAP, ISO 13485, SaMD, AI/ML, De Novo, 510(k), or PMA documentation and regulatory submissions

· Algorithm governance, version control, change management, and lifecycle management

Experience in diagnostics, molecular testing, genomics/transcriptomics, laboratory medicine, or regulated healthcare environments is strongly preferred.

Engagement will be project/task-based, with compensation commensurate with predefined scope, complexity, and data volume.

If interested, please send a brief summary of your experience and relevant projects via LinkedIn message or email to mkidd@wrenlaboratories.com.

Work Location: Remote