Consulting Medical Director

AccuScan Sciences

  • Milpitas, California
  • 22 days ago

    Highlights

    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.

    Numbers & Facts

    LocationMilpitas, California

    Description

    Description

    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

    Similar Jobs

    See more jobs