The Medical Director will provide clinical leadership and oversight for AccuScan鈥檚 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路聽聽聽聽聽聽聽Provide medical oversight for MRD and ctDNA-based oncology assays.
路聽聽聽聽聽聽聽Define clinical intended use, target populations, and reporting standards.
路聽聽聽聽聽聽聽Serve as primary clinical authority for assay interpretation and performance.
路聽聽聽聽聽聽聽Oversee medical review and sign-out of clinical reports where applicable.
2. CLIA/CAP Laboratory Oversight路聽聽聽聽聽聽聽Serve as CLIA Laboratory Director or Co-Director as applicable.
路聽聽聽聽聽聽聽Ensure compliance with CLIA, CAP, and state regulatory requirements.
路聽聽聽聽聽聽聽Oversee quality management systems and inspection readiness.
路聽聽聽聽聽聽聽Participate in proficiency testing and corrective action oversight.
3. Clinical Development Strategy路聽聽聽聽聽聽聽Lead medical oversight of clinical studies supporting MRD use cases.
路聽聽聽聽聽聽聽Collaborate with academic investigators and cooperative groups.
路聽聽聽聽聽聽聽Support publication strategy and conference presentations (e.g., ASCO, ESMO).
4. Market Access & Reimbursement Strategy路聽聽聽聽聽聽聽Provide medical input into MolDx submissions and payer dossiers.
路聽聽聽聽聽聽聽Align clinical evidence generation with reimbursement milestones.
路聽聽聽聽聽聽聽Engage with payers and CMS contractors as needed.
路聽聽聽聽聽聽聽MD or DO with board certification in Oncology, or related specialty.
路聽聽聽聽聽聽聽Eligible to serve as CLIA Laboratory Director (or ability to obtain licensure).
路聽聽聽聽聽聽聽8+ years experience in oncology diagnostics or molecular pathology.
路聽聽聽聽聽聽聽Experience with NGS, ctDNA, or MRD assays strongly preferred.
路聽聽聽聽聽聽聽Experience supporting CLIA/CAP laboratories.
路聽聽聽聽聽聽聽Familiarity with MolDx reimbursement pathway preferred.
- 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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