Consulting Medical Director

AccuScan Sciences; Milpitas (CA); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Health plan (Medical, Dental & Vision)

Retirement Plan (401k, IRA)

Life Insurance (Basic, Voluntary & AD&

Paid Time Off (Vacation, Sick & Public

Wellness Resources

Stock Option Plan

Job summary

AccuScan Sciences seeks a Medical Director to lead clinical strategy for precision oncology programs, including WGS-based MRD assays in colorectal and lung cancers. The role acts as senior clinical authority for LDTs, ensuring validity, regulatory compliance, and medical integrity across development and commercialization.

Ideal candidate has 8+ years in oncology diagnostics, board certification in Oncology, and proven experience with NGS, ctDNA, or MRD assays.

Qualifications

• MD or DO with board certification in Oncology; eligible for CLIA Laboratory Director role.
• 8+ years in oncology diagnostics or molecular pathology.
• Strong experience with NGS, ctDNA, or MRD assays.
• Familiarity with CLIA/CAP labs and MolDx reimbursement pathways.

Responsibilities

• Provide medical leadership for MRD and ctDNA-based oncology assays.
• Define clinical intended use, target populations, and reporting standards.
• Sign-out of clinical reports and medical review as applicable.
• Oversee CLIA/CAP compliance, quality systems, and proficiency testing.

Skills

Oncology leadership

Clinical governance

Regulatory/compliance oversight

Experience with NGS/ctDNA/MRD

MolDx reimbursement familiarity

Education

MD or DO with board certification in Oncology

Tools

NGS platforms

CAP/CLIA regulatory knowledge

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

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