Lead Counsel, 340B Government Programs

Scorpion Therapeutics; Cambridge (MA); On-site; USD 180,000 - 320,000; Full time

Benefits offered by this job

Comprehensive benefits package (med, d

Job summary

Sanofi seeks an experienced in-house counsel to lead all legal matters arising from the 340B Integrity Initiative in the United States. You will provide day-to-day oversight for the 340B Credit Model and manage federal/state litigation, investigations, and HRSA ADR proceedings.

You will monitor federal/state regulatory developments, advise on 340B intersections with MDRP, FSS, and Medicare Part B, and develop positions on interpretive questions. Strong communication and leadership are essential.

Qualifications

• J.D. (ABA-accredited); active bar membership in good standing.
• 8+ years’ experience in healthcare law, pharmaceutical pricing, government price reporting, or related field.
• Deep 340B expertise (contract pharmacy, duplicate discounts, diversion, HRSA oversight, ADR).
• Experience managing/supporting complex federal litigation involving HHS/HRSA/CMS.

Responsibilities

• Serve as lead in-house counsel on all legal matters arising from the 340B Integrity Initiative.
• Provide day-to-day legal oversight and strategic direction for the 340B Credit Model.
• Manage federal and state litigation, investigations, and enforcement actions implicating Sanofi’s 340B practices.
• Manage and coordinate HRSA Administrative Dispute Resolution (ADR) proceedings.
• Monitor, analyze, and advise on federal and state legislative and regulatory developments relating to 340B.
• Advise on intersection of 340B with MDRP, FSS, and Medicare Part B (duplicate discount prevention, Best Price implications, ceiling price calculations).
• Develop and update legal positions on 340B interpretive questions (covered entity eligibility, patient definition, contract pharmacy arrangements, orphan drug exclusions, HRSA oversight/enforcement, manufacturer obligations).
• Provide strategic counsel to senior leadership on risks, litigation strategy, regulatory developments, and policy options.
• Act as primary legal point of contact for cross-functional 340B matters.
• Monitor and analyze industry-wide 340B litigation and advise on implications.
• Represent Sanofi in PhRMA working groups/coalitions; coordinate positions with industry peers.
• Partner with Government Affairs/Public Policy on federal and state 340B legislative/regulatory positions.
• Engage HRSA, CMS, HHS OIG, and state Medicaid agencies; advocate for program integrity reforms.
• Train commercial, market access, and compliance teams on 340B legal requirements, Credit Model, ADR, and compliance obligations.

Skills

Communication skills

Leadership presence

Learning agility

Collaborative mindset

Education

J.D. (ABA-accredited)

Job description

Sanofi seeks an experienced in-house counsel to lead all legal matters arising from the 340B Integrity Initiative in the United States. You will provide day-to-day oversight for the 340B Credit Model and manage federal/state litigation, investigations, and HRSA ADR proceedings.

You will monitor federal/state regulatory developments, advise on 340B intersections with MDRP, FSS, and Medicare Part B, and develop positions on interpretive questions. Strong communication and leadership are essential.