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
1. 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.
2. 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.
3. 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).
4. 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