Senior Counsel, Commercial, US Market Access and Pricing

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. Responsibilities may also include advice on Alnylam global value and market access strategies. Ensure all agreements comply with applicable healthcare laws, internal polices and government pricing requirements. Advise business on payer customer disputes and resolution. 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. 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. 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. 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; 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.