Senior Counsel, Commercial, US Market Access and Pricing

Overview

The Senior Counsel, Commercial, US Market Access will provide expert advice and counseling to the business on a variety of strategic and tactical projects within a highly regulated environment across the US commercial business units. This position will report to the Vice President, Legal Commercial and will require working in a matrix setting in a fast paced, rapidly growing organization and will partner with various stakeholders, including with colleagues across the Commercial Legal team, as well as Commercial, Medical Affairs, Regulatory, Ethics & Compliance, Privacy and other expertise areas at Alnylam. In addition, the person in this role will regularly confer with peer counsel for US Patient Services and US Strategic Accounts.

The ideal candidate will have significant experience counseling prescription drug companies on legal issues relating to market access, government pricing, medical and pharmacy benefit coverage, contracting, federal and state laws impacting pricing and access, antitrust, state pricing transparency, and patient assistance.

This position ishybridand will be primarily located inCambridge, MA.

Key Responsibilities

Strategic Legal Counseling

• Serve as legal business partner to the commercial organization (in particular US Market Access), to provide pragmatic, solutions-oriented, proactive counseling in the development and execution of market access, product pricing and payer contracting strategies for established and newly launched marketed products in the US.
• Advise on:

• Distribution, trade, and channel strategy across specialty pharmacies, distributors, wholesalers, GPOs, and PBMs;
• Coverage and reimbursement strategies under Medicare Parts B and D, Medicaid, and Veterans Health Care Act;
• Governing pricing matters, such as requirements and compliance with Medicaid Drug Rebate Programs (MDRPs) including impact to Average Manufacturer Price (AMP), Best Price and other price reporting calculations, and PHS 340B program;
• Federal Supply Schedule (FSS) contract, including annual negotiation of FSS prices and reporting in compliance with Federal Acquisition Regulations (FARs) and the Veterans Health Care Act;
• Counsel day-to-day for market access clients, including review of certain promotional materials, training materials, statements of work, and other contracts.
• Counsel key stakeholders on legal, regulatory, and policy developments such as Inflation Reduction Act, 340B Pricing Programs, contract disputes with PBMs on rebate liabilities, fraud and abuse, privacy, government price reporting and antitrust. Responsibilities may also include advice on Alnylam global value and market access strategies.

Contracting & Transactional Support

• Draft, review, and negotiate a wide range of market access-related agreements, including:
  • PBM, GPO, wholesaler, specialty pharmacy, and distribution contracts.
  • Discount, rebate, value-based and risk-sharing agreements; and
  • Vendor agreements support market access, distribution, and patient support operations.
• Ensure all agreements comply with applicable healthcare laws, internal polices and government pricing requirements.
• Advise business on payer customer disputes and resolution.

Regulatory & Compliance Guidance

• Provide counsel on state and federal laws and regulations impacting market access operations, including:
  • Anti-kickback Statute, False Claims Act, OIG Guidance, PhRMA Code, and state drug pricing transparency laws.
• Assist with government price reporting audits and related processes.
• Assist with any Market Access-related audits (e.g., government price reporting).
• Support the development, implementation, and maintenance of internal policies, SOPs, and training programs to mitigate compliance risks.

Cross-Functional Collaboration

• Coordinate legal support by contributing as a member of cross-functional team and interacting with business and law department colleagues on various matters such as:
  • Advising on the development, design and implementation of Alnylam's patient support services and programs (e.g., Alnylam Assist) across all of Alnylam's portfolio, which includes 4 currently marketed products in the United States, new product entrants and indications, and relevant agreements with third party vendors; and
  • Analyzing market access iniatives, advisory board proposals, and patient support services to ensure that client operations comply with applicable laws, regulations, and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations, antitrust, and FDA requirements.

Team Leadership & Development

• Collaborate with other Alnylam lawyers across the broader legal department and as a member of cross-functional teams to ensure that advice and risk-tolerance is consistent, clear and implemented accordingly.
• Stay abreast of evolving healthcare legislation and regulations, and the enforcement landscape.
• Educate colleagues of all relevant legal and regulatory requirements and legal developments in their areas of business by developing and providing training and periodic updates.
• As a member of the Commercial Legal Team, actively contribute to the legal function by building a positive culture, fostering engagement, sharing best practices and participating in initiatives focused on building departmental and functional knowledge and competencies.
• Mentor junior legal staff.
• Additional responsibilities, as assigned, and as the organization evolves.

Qualifications

• JD from an ABA-accredited law school; member in good standing of a state bar and aility to obtain MA in-house counsel license if not barred in MA;
• 10 years of relevant post-JD experience advising on legal matters in a life sciences space, whether in a law firm, in-house in the biopharmaceutical industry, or both;
• Exceptional oral and written communication skills, including relevant contract drafting and redlining skills, and presentation capabilities;
• Excellent interpersonal and conflict resolution skills and ability to work in highly collaborative, team-oriented environment;
• Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with internal and external stakeholders;
• Strong analytical, attention-to-detail, problem-solving, and organization skills with demonstrated history of self-motivation to handle multiple competing priorities while meeting high quality and timeliness standards;
• Extensive experience advising on statutes, regulations, and guidance documents applicable to market access activities, including Medicaid, 340B program, Veterans Administration, federal and state anti-kickback statutes, state drug pricing transparency laws, OIG guidance documents and advisory opinions, the False Claims Act, and the PhRMA Code;
• Experience advising on discount, pricing, and contracting and sales matters, including anti-kickback, safe harbors, and fraud and abuse matters;
• Deep experience working with Integrated Delivery Networks (IDNs), hospital systems, and specialty distribution networks;
• Ability to effectively and efficiently manage outside counsel and adhere to a budget;
• Additional skills required for this role include:
  • Acting with high integrity and a demonstrated ability to treat confidential information with great discretion;
  • Ability to exercise good judgment, be forward-looking, and remain solution-oriented across a variety of situations.

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.