Address
Form of workOverview
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 Patient Services organizations, across the TTR and RARE business on a broad array of strategic and tactical projects within a highly regulated environment. This position will report to the Vice President, Lead Counsel, US Region and will be responsible for providing legal support to business partners in various departments across the organization, focused specifically on 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.
Key Responsibilities
• Manage arrangements with distributors, pharmacies, GPOs, PBMs, and payors
• Advise on:
o Medical and pharmacy benefit coverage and reimbursement, including under Medicare Parts B and D, Medicaid, Veterans Health Care Act;
o Payor interactions and contracting;
o Distributor and specialty pharmacy interactions and contracting;
o GPO interactions and arrangements;
o PBM interactions and arrangements;
o Policy development and SOP reviews
• Counsel day-to-day for market access clients, including review of certain promotional materials, training materials, statements of work, and other contracts
• Assist with a broad range of other healthcare regulatory matters including funding requests and client and vendor training
• Advise business on discount, rebate/price concession strategies, copay/patient assistance programs, policy development, risk mitigation, interactions with customers, payer customer disputes and resolution.
• Draft, negotiates and reviews 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 contribute 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.
• Supervise one or more junior colleagues in this role.
Qualifications
• 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
• JD from an ABA accredited law school 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
• 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.
• Additional skills needed for this role include:
o High integrity and demonstrated ability to treat confidential information with great discretion
o Strong organizational and prioritization skills
o A proven, collaborative team player and pro-active self-starter with strong follow-through
o Able to exercise good judgment, be forward looking, and remain solution-oriented across a variety of situations.
o Able to operate under tight deadlines in a multi-task role, with changing priorities in an, exciting rapidly growing company
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 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 2022, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2023 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. Alnylam is an E-Verify employer.
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 Patient Services organizations, across the TTR and RARE business on a broad array of strategic and tactical projects within a highly regulated environment. This position will report to the Vice President, Lead Counsel, US Region and will be responsible for providing legal support to business partners in various departments across the organization, focused specifically on 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.
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:
• Manage arrangements with distributors, pharmacies, GPOs, PBMs, and payors
• Advise on:
o Medical and pharmacy benefit coverage and reimbursement, including under Medicare Parts B and D, Medicaid, Veterans Health Care Act;
o Payor interactions and contracting;
o Distributor and specialty pharmacy interactions and contracting;
o GPO interactions and arrangements;
o PBM interactions and arrangements;
o Policy development and SOP reviews
• Counsel day-to-day for market access clients, including review of certain promotional materials, training materials, statements of work, and other contracts
• Assist with a broad range of other healthcare regulatory matters including funding requests and client and vendor training
• Advise business on discount, rebate/price concession strategies, copay/patient assistance programs, policy development, risk mitigation, interactions with customers, payer customer disputes and resolution.
• Draft, negotiates and reviews 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 contribute 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.
• Supervise one or more junior colleagues in this role.
Qualifications
• 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
• JD from an ABA accredited law school 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
• 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.
• Additional skills needed for this role include:
o High integrity and demonstrated ability to treat confidential information with great discretion
o Strong organizational and prioritization skills
o A proven, collaborative team player and pro-active self-starter with strong follow-through
o Able to exercise good judgment, be forward looking, and remain solution-oriented across a variety of situations.
o Able to operate under tight deadlines in a multi-task role, with changing priorities in an, exciting rapidly growing company
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 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 2022, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2023 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. Alnylam is an E-Verify employer.
