Consulting Medical Director at AccuraGen

Milpitas, California, United States -

Full Time

Start Date

Immediate

Expiry Date

16 May, 26

Salary

0.0

Posted On

15 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Leadership, Oncology, Whole-Genome Sequencing, MRD Assays, LDTs, Regulatory Compliance, Assay Development, CLIA, CAP, Quality Management Systems, Clinical Studies, MolDx Submissions, Payer Dossiers, NGS, ctDNA, Molecular Pathology

Industry

Biotechnology

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 Responsibilities1. 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

Responsibilities

The Medical Director will provide clinical leadership and oversight for precision oncology programs, focusing on whole-genome sequencing-based minimal residual disease (MRD) assays in various solid tumors. This role acts as the senior clinical authority for laboratory-developed tests (LDTs), ensuring clinical validity and regulatory compliance throughout the assay lifecycle.