Consulting Medical Director

AccuraGen; Milpitas (CA); On-site; USD 250,000 - 380,000; Full time

Benefits offered by this job

Health Care Plan

Retirement Plan

Life Insurance

Paid Time Off

Wellness Resources

Stock Option Plan

Job summary

AccuScan seeks a Medical Director to provide clinical leadership for precision oncology programs, including whole-genome sequencing-based MRD assays in colorectal cancer and other solid tumors.

This role is the senior clinical authority for laboratory-developed tests (LDTs), ensuring clinical validity, regulatory compliance, and medical integrity across assay development, validation, and commercialization.

Qualifications

• MD or DO with board certification in Oncology or related specialty.
• Eligible to serve as CLIA Laboratory Director.
• 8+ years experience in oncology diagnostics or molecular pathology.
• Experience with NGS, ctDNA, or MRD assays preferred.
• Experience supporting CLIA/CAP laboratories.
• Familiarity with MolDx reimbursement pathway preferred.

Responsibilities

• Provide medical leadership 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.
• Ensure CLIA/CAP regulatory compliance and state requirements.
• Oversee quality management systems and inspection readiness.
• Lead medical oversight of clinical studies supporting MRD use cases.
• Collaborate with academic investigators and cooperative groups.
• Support publication strategy and conference presentations.

Skills

Clinical leadership

Oncology diagnostics

NGS experience

Regulatory compliance

Education

MD/DO with board certification in Oncology

Tools

CLIA/CAP oversight

Job 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

• 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
• 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
• 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)
• 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