The Medical Director will provide clinical leadership and oversight for AccuScan’s precision oncology programs, including whole-genome sequencing (WGS)-based minimal residual disease (MRD) assays in colorectal cancer, lung cancer, and other solid tumors. This role serves as the senior clinical authority for laboratory-developed tests (LDTs), ensuring clinical validity, regulatory compliance, and medical integrity across assay development, validation, and commercialization.
· Provide medical oversight for MRD and ctDNA-based oncology assays.
· Define clinical intended use, target populations, and reporting standards.
· Serve as primary clinical authority for assay interpretation and performance.
· Oversee medical review and sign-out of clinical reports where applicable.
· Serve as CLIA Laboratory Director or Co-Director as applicable.
· Ensure compliance with CLIA, CAP, and state regulatory requirements.
· Oversee quality management systems and inspection readiness.
· Participate in proficiency testing and corrective action oversight.
· Lead medical oversight of clinical studies supporting MRD use cases.
· Collaborate with academic investigators and cooperative groups.
· Support publication strategy and conference presentations (e.g., ASCO, ESMO).
· Provide medical input into MolDx submissions and payer dossiers.
· Align clinical evidence generation with reimbursement milestones.
· Engage with payers and CMS contractors as needed.
Requirements
· MD or DO with board certification in Oncology, or related specialty.
· Eligible to serve as CLIA Laboratory Director (or ability to obtain licensure).
· 8+ years experience in oncology diagnostics or molecular pathology.
· Experience with NGS, ctDNA, or MRD assays strongly preferred.
· Experience supporting CLIA/CAP laboratories.
· Familiarity with MolDx reimbursement pathway preferred.
Benefits
Consulting Medical Director • Milpitas, CA, US
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