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Job description
Position Overview
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.
Key Responsibilities
Clinical & Scientific Leadership
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
CLIA/CAP Laboratory Oversight
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
Clinical Development Strategy
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)
Market Access & Reimbursement Strategy
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
Health Care Plan (Medical, Dental & Vision)
Retirement Plan (401k, IRA)
Life Insurance (Basic, Voluntary & AD&D)
Paid Time Off (Vacation, Sick & Public Holidays)
Wellness Resources
Stock Option Plan
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Worksite address
milpitas, CA, 95035, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.