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