Assistant General Counsel Policy, Strategy & Litigation

Initial Therapeutics, Inc.; Washington; On-site; USD 210,000 - 310,000; Full time

Job summary

Sanofi Inc. in the United States seeks an Assistant General Counsel to shape policy, strategy, and litigation across drug pricing and access programs. You will advise senior leadership on internal positions and coordinate cross-functional efforts with Market Access Legal, General Counsel, and Communications.

The role includes operational aspects of the 340B program and strategic advocacy. Qualified candidates will have a J.D., 8+ years of experience in complex litigation and policy development,

Qualifications

• J.D. from ABA-accredited law school and active bar membership in good standing.
• Minimum 8 years of experience in complex litigation and strategic policy work at a global company, government agency, or top law firm.
• Ability to master complex subjects quickly and advise senior leaders.

Responsibilities

• Define internal legal positions on drug pricing and government program issues (340B, MFN, PBM reform).
• Develop and coordinate environment-shaping strategy with Law Division and senior leadership.
• Monitor federal/state legislative and regulatory developments and translate analysis into actionable guidance.
• Lead day-to-day legal aspects of 340B program implementation and related proceedings.
• Identify affirmative litigation and advocacy opportunities aligned with pricing and access goals.
• Advise on litigation risk and strategic implications of policy and program design choices.
• Collaborate with business, policy, and communications teams to position Sanofi medicines.

Skills

Legal strategy

Policy analysis

Executive presence

Communication

Leadership

Education

J.D. from ABA-accredited law school

Job description

Job Title: Assistant General Counsel Policy, Strategy & Litigation

• Location: Washington, DC/Morristown, NJ/Cambridge, MA

About the Job

Ready to push the limits of whats possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

This is a senior, high-visibility strategic legal role within Sanofis LEBI organization. The Assistant General Counsel Policy, Strategy & Litigation will help shape how Sanofis Law Division engages the external policy and legal environment that governs how its medicines are priced, purchased, distributed, reimbursed, and accessed. This is not a role that owns a single program it is a role that helps the Law Division think and act strategically across the full landscape of U.S. government pricing and drug pricing reform, including the 340B Drug Pricing Program, PBM reform, Most Favored Nation (MFN) implementation, IRA drug price negotiation, and related federal and state policy developments.

This role reports to the Head of Market Access Legal and will partner closely with the business, the North America General Counsel, the Head of Litigation, the Head of Public Policy & Corporate Affairs, and Communications among others to define Sanofis internal positions, shape affirmative litigation and advocacy strategy, and help design and defend internal programs that advance Sanofis interests and the interests of patients. The role will also maintain day-to-day responsibility for a portion of Sanofis 340B program implementation, providing a concrete operational anchor for the broader strategic mandate. This is a rare opportunity to help build a strategic capability at the center of the Law Division translating legal analysis into positions, programs, and advocacy that shift the external environment in Sanofis favor.

About Sanofi:

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Main Responsibilities

Policy Strategy & Environment Shaping:

• Help define Sanofis internal legal positions on the drug pricing and government program issues that matter most to the business and the patients it serves including 340B, PBM reform, MFN implementation, and government pricing programs more broadly (Medicaid Drug Rebate Program, Federal Supply Schedule, Medicare Part B/Part D).

• Partner with the Head of Market Access Legal, the North America General Counsel, the Head of Litigation, and the Head of Public Policy & Corporate Affairs among others to develop the Law Divisions environment-shaping strategy identifying where legal, policy, and advocacy tools can be used together to favorably position Sanofis medicines and the broader industry.

• Monitor and analyze federal and state legislative, regulatory, and litigation developments affecting drug pricing, government programs, and access, and translate that analysis into actionable recommendations for senior leadership.

340B Program Implementation:

• Serve as day-to-day legal lead on a defined portion of Sanofis 340B program implementation, including aspects of the 340B Integrity Initiative and Credit Model.

• Manage or support 340B HRSA Administrative Dispute Resolution (ADR) proceedings and related federal and state legal matters, in coordination with the Litigation team.

• Maintain current legal positions on key 340B interpretive questions covered entity eligibility, patient definition, contract pharmacy arrangements, orphan drug exclusions, duplicate discounts, and diversion and ensure they are reflected consistently in Sanofis broader policy and litigation strategy.

Affirmative Litigation & Strategy:

• Proactively identify, assess, and help develop affirmative litigation and advocacy opportunities that advance Sanofis drug pricing and market access positions.

• Provide litigation strategy counsel across the Law Divisions drug pricing and government program docket, working alongside (not in place of) the attorneys managing individual matters, to ensure litigation positions are coordinated with Sanofis broader policy and advocacy strategy.

• Advise on the litigation risk and strategic implications of policy positions and program design choices before they are adopted.

Internal Program Design & Defense:

• Partner with market access legal, market access, and government pricing teams to help design internal programs (e.g., 340B integrity and credit programs, PBM-related initiatives) that are both commercially sound and legally defensible.

• Help build the legal and factual record needed to defend Sanofis programs in litigation, agency proceedings, and public/legislative debate.

Advocacy & Third-Party Engagement:

• Serve as Sanofis representative on key trade association working groups (e.g., PhRMA) addressing drug pricing reform, government pricing, and market access policy, representing Sanofis interests and coordinating positions with industry peers.

• Represent Sanofis legal perspective in other industry coalitions and forums on drug pricing reform, government pricing, and market access policy.

• Collaborate with Government Affairs, Public Policy, and Communications to develop and advance Sanofis legislative and regulatory positions, including engagement with Congress, HHS, CMS, HRSA, and relevant state agencies.

• Engage directly with government and regulatory agencies to represent Sanofis legal perspective and advocate for policy outcomes consistent with Sanofis strategy.

Cross-Functional Partnership & Senior Leadership Counsel:

• Serve as a trusted strategic advisor to senior Law Division and business leadership, preparing and presenting clear, actionable analysis on high-stakes drug pricing and policy questions.

• Serve as a primary point of contact ensuring legal, policy, and litigation strategies are integrated and coherent across functions rather than developed in silos.

• Prepare and deliver training to commercial, market access, and compliance teams on relevant legal requirements and strategic positioning.

About You

Basic Qualifications

• J.D. from an ABA-accredited law school; active bar membership in good standing in at least one U.S. jurisdiction.

• Minimum 8 years of experience as a practicing attorney, including substantial experience in complex litigation (through discovery, dispositive motions, and/or trial) and in developing and executing legal or policy strategy at a global company, government agency, trade association, or top law firm.

• Demonstrated ability to master complex, unfamiliar subject matter quickly and to exercise sound judgment before becoming a subject-matter expert.

• Demonstrated strategic thinking, creativity, and sound judgment a track record of shaping positions and strategy, not just executing on settled ones.

• Strong executive presence and communication skills, with the ability to advise and influence senior leaders and to represent the Law Division credibly with external stakeholders.

• Highly collaborative, with the interpersonal skill to build trust and alignment across legal, business, and policy functions.

Preferred Qualifications

• Working knowledge of the 340B Drug Pricing Program and other federal government pricing programs (Medicaid Drug Rebate Program, Federal Supply Schedule, Medicare Part B/Part D), including familiarity with Best Price, AMP, and ceiling price concepts. Direct 340B experience (contract pharmacy, duplicate discounts, diversion, HRSA ADR proceedings) is a plus given this roles ongoing operational 340B responsibilities but is not required at hire.

• Experience with, or working knowledge of, PBM reform, Most Favored Nation (MFN) policy, Inflation Reduction Act (IRA) drug price negotiation, or related drug pricing reform issues.

• Experience litigating constitutional claims, statutory and regulatory challenges, and/or Administrative Procedure Act (APA) matters.

• Experience engaging with trade associations, government agencies, and/or state attorneys general on policy or litigation matters.

• A federal appellate clerkship or comparable litigation pedigree.

• Enthusiasm for using AI and emerging technology to work more effectively.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

• Make your work count by supporting a company that brings life-changing treatments to millions and is committed to doing right by patients, communities, and the planet.

• Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably

• Support teams across science, medicine, and operations by building better systems, shaping bold strategies, and enabling innovation at speed

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affluent employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.