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Consulting Medical Director

AccuScan Sciences · Milpitas, California, United States

Diagnostics / LaboratoryExecutive LevelQuick applyfull-time2 days ago

About The Role

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.
  1. 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.
  1. 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).
  1. 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.
  • 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.
  • 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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