Consulting Medical Director

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