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