Senior Legal Director, US Market Access and Commercial Operations

Overview

You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.

The Senior Legal Director US Market Access and Commercial Operations will provide expert advice and counseling to Alnylam US Value & Access, US Strategic Accounts and US Patients Services organizations, across the US TTR and Global RARE business units on a broad array of strategic and tactical projects within a highly regulated environment.

This position will report to the Senior Vice President, General Counsel Commercial and will require you to work in a matrix setting in a fast-paced, rapidly growing organization, partnering effectively with various stakeholders, including colleagues in the Commercial Legal team as well as Medical Affairs, Commercial, Regulatory, Ethics & Compliance, Privacy and other expertise areas at Alnylam.

As a subject matter expert for business partners, you will be working with various departments across the organization, including but not limited to teams that interact with specialty pharmacies / distributors, payors, and Integrated Delivery Networks (IDNs).

The ideal candidate will have a deep understanding of healthcare laws as they relate to market access issues such as patient support programs;

field reimbursement teams; trade, GPO, PBM and payor relationships and contracts; medical and pharmacy benefit coverage and reimbursement; and drug pricing.

This position is hybrid and will be primarily located in Cambridge, MA .

Key Responsibilities

• Serve as legal business partner to the commercial organization (in particular US Market Access, Channel & Distribution, Patient Services, and Health System Director teams) and providing pragmatic, solutions-oriented, proactive counseling in the development and execution of access, product pricing and payer contracting strategies for established and newly launched products in the US, including :
• Manages arrangements with distributors, pharmacies, GPOs, PBMs, and payors
• Advises on :
• Medical and pharmacy benefit coverage and reimbursement, including under Medicare Parts B and D, Medicaid, Veterans Health Care Act;
• Payor interactions and contracting;
• Distributor and specialty pharmacy interactions and contracting;
• GPO interactions and arrangements;
• PBM interactions and arrangements;
• Policy development and SOP reviews
• Counsels day-to-day for market access clients, including review of certain promotional materials, training materials, statements of work, and other contracts
• Assists with a broad range of other healthcare regulatory matters including funding requests and client and vendor training
• Advises business on discount, rebate / price concession strategies, copay / patient assistance programs, policy development, risk mitigation, interactions with customers, payer customer disputes and resolution.
• Draft, negotiate and review market access related agreements, including : PBM agreements, GPO agreements, Specialty Pharmacy agreements, wholesaler agreements, discount and rebate agreements, distribution agreements, innovative / value-based agreements, market research agreements, vendor agreements, and service agreements.
• Counsel key stakeholders on legal, regulatory and policy developments such as Inflation Reduction Act, fraud and abuse, privacy, government price reporting and antitrust.

Responsibility may also include advice to the Alnylam global value and access strategies.

• Advise on the development and expansion of Alnylam's patient support program (Alnylam Assist) across all of Alnylam's portfolio, which includes 4 currently marketed products in the United States, and new product entrants and indications and relevant agreements with third party vendors.
• Analyze market access initiatives, advisory board proposals, patient support services to ensure that client operations comply with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations, antitrust, and FDA requirements.
• Coordinate legal support by contributing as a member of cross-functional team and interacting with business and law department colleagues on various matters
• Collaborate with other Alnylam lawyers and as a member of cross-functional team to ensure that advice and risk-tolerance is consistent and clear and implemented accordingly.
• Ensure that colleagues are kept abreast 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 Leadership 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.
• Additional responsibilities, as assigned as the organization evolves, including supervising one or more junior colleagues in this role.

Qualifications

• JD from an ABA accredited law school required and member of a state bar
• Minimum of 10 years post-JD experience advising on legal matters in a life sciences space, whether in a law firm or in-house in the biopharmaceutical industry, or both
• Exceptional oral and written communication skills, including drafting 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 the client organizations
• History of self-motivation, working independently on projects, meeting aggressive deadlines, and juggling multiple matters
• 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
• Advanced contracting and redlining skills with strong attention to detail
• Excellent analytical, problem-solving and organizational skills to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards
• Ability to effectively and efficiently manage outside counsel and adhere to a budget
• Experience drafting, interpreting, and negotiating contracts with customers.
• Experience with discount, pricing, contracting and sales matters, including anti-kickback, safe harbors, and fraud and abuse matters.
• High integrity and demonstrated ability to treat confidential information with great discretion
• Strong organizational and prioritization skills
• A proven, collaborative team player and pro-active self-starter with strong follow-through
• Able to exercise good judgment, be forward looking, and remain solution-oriented across a variety of situations.
• Able to operate under tight deadlines in a multi-task role, with changing priorities in an exciting rapidly growing company.

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