DELFI Diagnostics is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges.
Requirements
- 10+ years experience with NGS technologies, assay development, and multi-omics integration
- Proven track record in high-throughput assay development, LIMS, and laboratory automation as evidenced by assays released into production and/or publication record
- Deep understanding of regulatory requirements for diagnostic test development (FDA Class I/II/III, 510(k), De Novo, CDx, CAP, CLIA, NYSDPH)
- Experience with both LDT operations and IVD development pathways
- Experience with clinical trial design and biomarker validation studies
- Six Sigma, Design of Experiment (DOE)
- Experience with liquid biopsy, ctDNA, or minimal residual disease detection
Responsibilities
- Oversee development of NGS-based cancer diagnostic assays from concept to clinical implementation
- Champion high-throughput assay development and automation strategies to support scalable operations
- Ensure robust analytical validation and clinical validation studies meet regulatory requirements for both LDT and IVD pathways
- Drive continuous improvement of existing assay performance, including sensitivity, specificity, and turnaround time
- Ensures assay development is conducted with rigorous adherence to Design Control practices, following the Quality Management System (QMS).
- Ensures thorough documentation of development processes, experimental results, and data analyses to support internal decision-making and regulatory submissions.
- Ensures robustness of assays and facilitates design transfer to other departments including, but not limited to Manufacturing, Quality Systems, Regulatory Affairs and Marketing.
Other
- PhD in Molecular Biology, Genetics/Genomics, Biochemistry, or related field with 20+ years of experience
- Minimum 8 years in senior leadership roles in diagnostics, biotechnology, or pharmaceutical industry, exemplifying best practice in recruiting, team-building, employee performance management and career development, goal-setting, and cross-functional collaboration
- Strong publication record and demonstrated thought leadership in cancer diagnostics, genetics, genomics, or related fields
- Superb written, verbal communication, and influencing and presentation skills, including the ability to communicate complex concepts succinctly to a variety of audiences
- Decisive, proactive, and composed with a balance of high IQ and EQ
