This position can be based at any of the following Alexion (AstraZeneca) locations; Boston, MA, Gaithersburg, MD, and Wilmington, DE, and may require up to 20% travel.
This is what you will do:
We are seeking a Director, US Market Access Counsel to join the Alexion US Commercial Law Practice Group. This position will provide legal support on a broad range of market access and healthcare issues to the US Market Access and Strategic Accounts teams.
The ideal candidate must have a strong understanding of US healthcare laws as they relate to payer relationships and contracting, coverage and reimbursement, pricing strategy, patient support programs, and price reporting obligations.
This role will routinely interact with senior US management and will be required to work across a number of Alexion functional groups. The ideal candidate must have strong communication and collaboration skills, be proactive and be able to work independently while managing multiple projects and clients.
You will be responsible for:
Developing and maintaining a deep understanding of healthcare laws and compliant industry practices relating to market access for Alexion drugs, including:
Strategic contracting with payers, distributors, and specialty providers
Contracting with government payers
Coverage and reimbursement, in particular for Part B drugs
Pricing dynamics and access for drugs for ultra-rare diseases and conditions
Pricing and pricing strategy considerations
Government price reporting, including state price transparency reporting requirements
Patient assistance programs, including support for in-home services
Providing day-to-day counseling to the US Market Access and the Strategic Accounts teams, including:
Counseling key stakeholders to ensure compliance with key healthcare laws, regulations, and guidance, including the Federal Food, Drug & Cosmetic Act, the Anti-Kickback Statute, federal and state government price reporting obligations, the False Claims Act, HHS-OIG guidance, and the PhRMA Code on Interactions with Healthcare Professionals
Providing strategic support for the negotiation of government and key commercial-pay contracts
Serving as a reviewer for promotional and training materials prepared by the US Market Access and Strategic Accounts teams
Partnering with the Alexion Compliance function to continuously assess and mitigate healthcare compliance risks relating to the Alexion market access and patient support programs
Advising on internal policy and process matters relating to patient access to Alexion products
Helping to coordinate input from internal legal experts as needed (e.g., input from in-house counsel focusing on privacy, clinical research, human resources, securities laws, etc.) to support the Market Access and Patient Services, teams
Working with the Alexion contracts group to ensure that the routine contracting needs of the US market access and the patient services teams are met in a timely, efficient, and compliant manner
Partnering with the Alexion Corporate Affairs function to evaluate proposed legislation and regulations that affect the market access or patient support teams
Effectively manage outside counsel, as appropriate, for advice on market access and patient support program-related issues
You will need to have:
5+ years of legal expertise focusing on pharmaceutical market access issues
Substantial expertise advising on reimbursement issues for Part B drugs
Prior experience advising senior executives
Strong communication skills
Ability to work in a matrixed environment
Eligibility to practice law in the United States
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
2+ years of in-house legal experience in the pharmaceutical industry
Prior experience advising on market access issues for rare or ultra-rare conditions
Prior experience advising on advertising and promotion-related issues for prescription drugs
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders..., hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes' list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.