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.