Unknown Company

Consulting Medical Director

milpitas, ca • Posted Today
Onsite Contract Physicians & Doctors

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.
  • 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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Consulting Medical Director in milpitas at Unknown Company

This position is listed as contract and onsite.

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