Head, US Commercial Legal

San Francisco, CA
Full Time
Job #: 21292 Exp.: 14+ Years
Position Summary
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 a number of 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 Complinance 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

Essential Qualifications
  • 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

Preferred Qualifications
  • 4+ years of in-house experience in the pharmaceutical industry
  • Prior experience advising on products for rare or ultra-rare conditions

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