Vice President, Legal – Lead Commercial Counsel
$272,000–$340,000 year
Hybrid · Boston, Massachusetts, United States
Job Summary
Lead Commercial Counsel for Zenas’ U.S. commercial framework, partnering with Commercial, Medical Affairs, Market Access, and Patient Support to advise on pre-launch and launch activities, pricing/reimbursement strategies, contracting, and regulatory compliance. Serve as SME on U.S. healthcare laws, FDA promotional regulations, and industry codes, guiding content review for Promotional Review Committee, Medical Legal Regulatory Review, and related committees; train personnel; oversee outside counsel; support compliance program enhancements (AKS, FCA) and cross-functional legal support across the business. This role leads the legal strategy for the anticipated first U.S. product launch (obexelimab) and will be based in the U.S. headquarters with hybrid work arrangements.
Required Qualifications
- JD required
- 12+ years of relevant legal experience in the biopharmaceutical industry
- Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG guidance, and industry codes
- Experience providing legal support to Commercial, Medical Affairs, Market Access, and Patient Support functions
- Experience reviewing promotional and medical materials as a Legal reviewer
- Ability to interpret and apply healthcare laws to complex business activities
- Experience supporting product launch planning and cross-functional review committees
- Strong business partnering orientation with ability to balance risk and business goals
- Excellent written and verbal communication skills
- Ability to manage multiple priorities in a fast-paced environment
- In-house biotech experience strongly preferred
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