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We are seeking a Head, US Commercial Legal to lead the Alexion US Commercial Legal Group. This position will report to the Alexion Chief Legal Officer and will be a member of both the Legal Leadership Team and the US Leadership Team. This role serves as the primary legal partner for the US Commercial and US Medical Affairs functions. In addition, this position will oversee a group comprised of four direct reports and three or more indirect reports. The ideal candidate must have a deep understanding of US healthcare and healthcare fraud and abuse laws as they relate to the advertising, promotion, distribution, and reimbursement of prescription drugs.
This role will routinely interact with senior US management and C-suite executives and will be required work across several Alexion functional groups. The ideal candidate must have strong communication and collaboration skills, be proactive, executive presence and be able to work independently while managing multiple projects and clients.
Job Duties & Responsibilities
Serve as the primary legal partner for the Senior Vice President responsible for overseeing the Alexion commercial function
Oversee the efforts of four seasoned attorneys and three or more indirect support staff to ensure that the US commercial and medical affairs functions receive timely and pragmatic legal advice that is consistently delivered across all related functions
Calibrate legal and execution risk to ensure sustainability and avoid derailers
Coordinate input from senior internal legal experts as needed (e.g., input from in-house counsel focusing on privacy, clinical research, human resources, securities laws, etc.)
Partner with the Alexion Compliance function to continuously assess and mitigate healthcare compliance risk relating to the Alexion US commercial and medical affairs functions
As a member of the Alexion Legal Leadership Team, drive projects to support the vision of One Legal (e.g., contracting efficiency, utilization of preferred outside counsel, implementation of knowledge management systems, etc.)
Develop and maintain a deep understanding of healthcare laws and compliant industry practices relating to advertising, promotion, distribution, and reimbursement of Alexion drugs, including:
the Federal Food, Drug & Cosmetic Act
the Anti-Kickback Statute (AKS)
the False Claims Act (FCA)
HHS-OIG guidance relating to the pharmaceutical industry practices
FDA regulations and guidance relating to the promotion and distribution of prescriptions drugs laws, regulations, and guidance relating to prescription drug overage and reimbursement, in particular for Part B and Part D drugs
the PhRMA Code on Interactions with Healthcare Professionals
Proactively manage a budget, through thoughtful use of outside counsel spend and attention to internal legal expenses
14+ years of legal expertise
Prior experience managing other lawyers and legal professionals, either directly or indirectly
Substantial expertise advising on healthcare laws, advertising and promotion, and reimbursement-related issues for life science companies
Substantial experience advising at the senior executive and C-suite levels
Strong communication skills
Ability to work in a matrixed environment
Eligible to practice law in the United States
4+ years of in-house experience in the pharmaceutical industry
Prior experience advising on products for rare or ultra-rare conditions
Internal Number: 21292)
About Alexion Pharmaceuticals, Inc.
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, hypopho...sphatasia (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.
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