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 Responsibilities1. 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
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Health Care Plan (Medical, Dental & Vision)
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Retirement Plan (401k, IRA)
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Life Insurance (Basic, Voluntary & AD&D)
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Paid Time Off (Vacation, Sick & Public Holidays)
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Wellness Resources
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Stock Option Plan
