Legal Counsel

Position Overview:

We are seeking a seasoned Counsel to serve as the primary legal advisor for our LDT-focused clinical laboratory. This role will oversee all legal matters across corporate governance, intellectual property, commercial and strategic transactions, regulatory compliance, and payer access (Medicare and commercial insurers). The ideal candidate brings deep expertise in the regulatory environment for Laboratory Developed Tests (LDTs), including CLIA, CAP, and evolving FDA policy frameworks.

Key Responsibilities:

Corporate & Governance

• Advise senior leadership and the Board on corporate governance, compliance, and strategic legal issues.
• Draft and negotiate corporate agreements, investor documentation, governance policies, and risk-management frameworks.
• Support corporate development initiatives, including partnerships, collaborations, acquisitions, international subsidiaries, and joint ventures.
• Manage fund-raising process including investor relation communications.

Commercial & Transactional

• Draft, negotiate, and manage contracts central to LDT operations, including laboratory services agreements, clinical collaborations, R&D partnerships, distribution agreements, MSAs, NDAs, and vendor/supplier agreements.
• Counsel business teams on commercialization strategies, contracting models, and compliant business practices.
• Support sales channels, and go-to-market strategies for clinical and research services offerings.

Intellectual Property

• Develop and execute IP strategies aligned with the company’s technologies, algorithms, software, and proprietary workflows.
• Manage patent and trademark portfolios, oversee external IP counsel, and evaluate freedom-to-operate in relevant assay and diagnostic spaces.
• Support licensing, technology transfer, and data-use agreements essential to assay development and validation.

Regulatory & Compliance

• Guide the organization through federal and state regulatory frameworks governing LDTs, including CLIA, CAP, state laboratory licensure, HIPAA, and genetic testing laws.
• Monitor evolving FDA policy on LDTs (e.g., rulemaking, enforcement discretion shifts) and advise leadership on risk, strategy, and implementation as well as international regulatory submissions in Japan.
• Develop and maintain robust compliance programs addressing quality systems, data privacy, billing, and clinical validation.
• Partner with quality, regulatory, and scientific teams to ensure compliant test development, validation, launch, and marketing.

Medicare & Payer Access

• Provide legal guidance on reimbursement pathways for LDTs, including coding, coverage, and payment strategies under Medicare, Medicaid, and commercial plans.
• Support payer engagement and contracting, including appeals, audits, and negotiations related to LDT reimbursement.
• Ensure compliance with billing rules, medical-necessity standards, and healthcare fraud/waste/abuse laws (e.g., AKS, Stark, FCA).
• Advise on payer-related policies that affect LDT commercialization under local MAC and clinical-utility requirements.

Risk Management & Internal Legal Support

• Provide legal support on privacy, data rights, cybersecurity, employment, clinical collaborations, and general corporate matters.
• Lead or support investigations and regulatory responses related to CMS, OIG, state health departments, and other oversight bodies.
• Manage outside counsel and ensure efficient allocation of legal resources.

Qualifications:

• Juris Doctor (JD) from an accredited law school; active bar membership in good standing.
• 7+ years of legal experience, ideally with a mix of law-firm and in-house roles in diagnostics, LDTs, clinical laboratories, or life sciences.
• Demonstrated expertise with CLIA, CAP, HIPAA, state lab laws, and payer-related regulatory frameworks.
• Experience navigating FDA policies impacting LDTs and IVDs (including evolving oversight structures).
• Strong background in commercial transactions, IP strategy, clinical trials, and compliance programs within a scientific or regulated environment.
• Excellent negotiation, communication, and cross-functional collaboration skills.
• Legal team management.

About BOSTONGENE:

BostonGene is pioneering the development of AI-driven biomedical software for the analysis of multi-omic data from cancer patients on the individual and cohort level. To support this mission, we have a cutting-edge high-complexity molecular laboratory that generates large volumes of high quality data, and a state-of-the-art dry lab staffed by an unparalleled team of data scientists and bioinformaticians. This service is used by our biopharma partners to provide custom solutions for clinical trials; from biomarker discovery to companion diagnostic development. We provide immediate diagnostic solutions for clinicians, such as our Tumor PortraitTM test to tailor optimal treatment strategies to improve cancer patient outcomes.