Job Summary
Our company is focused on developing treatments for serious immunological diseases. The Executive Director, Healthcare Legal will serve as the primary healthcare attorney for commercial functions.
Key Responsibilities:
Advising the commercial team: Serve as the primary legal advisor to commercial team members and partner with commercial teams on business strategies and risk mitigation.
Influencing marketing, market access, and sales by identifying and communicating risks associated with complex business activities.
Advise clients on discount, rebate/price concession strategies, government pricing, copay/patient assistance programs, policy development, risk mitigation, and interactions with payers/HCPs/HCOs.
Review and negotiate commercial and market access-related agreements (HCP/HCO services, PBM, Specialty Pharmacy, discount/rebate, distribution, market research).
Advise on promotional review committees for marketing, market access, and patient support assets.
Assist with investigations and resolutions of compliance issues and respond to challenges from competitors or regulatory authorities regarding product claims and related matters.
Work with colleagues to ensure adherence to policies and provide training on applicable legal issues.
Provide value-added legal and business insight to evaluate and mitigate risks.
Collaborate with Legal and Compliance colleagues to provide holistic legal support.
Demonstrate flexibility and a growth mindset while offering practical solutions to complex legal challenges.
Keep abreast of changes in healthcare laws and guidance and advise on necessary actions.
Requirements
JD from an accredited law school and admission to practice in California (CA RIHC license acceptable if required).
Minimum 10–12 years of directly relevant healthcare law experience in the bio-pharmaceutical industry; in-house experience launching a commercial drug is strongly preferred.
Strong knowledge of U.S. and global healthcare laws and regulations (AKS/FCA, FDCA, PhRMA Code, FCPA, FDA/OIG guidance, FTC/FCC/SEC guidance, etc.) with preferred experience in ex-US regulations.
Excellent communication, analytical, and relationship-building skills with ability to work independently and cross-functionally.
Desire to grow, develop, and learn beyond immediate subject matter when opportunities arise.