Position Summary:The Vice President, Legal - Lead Commercial Counsel will lead the commercial legal function with primary responsibility to support our expected first U.S. product launch (specifically, our antibody obexelimab for patients living with IgG4-RD, for which a BLA was submitted to FDA in May 2026). This individual serves as a trusted strategic partner and provides practical, timely and business-savvy legal advice to the Commercial (Sales, Marketing, Market Access, Analytics), Medical Affairs and Patient Support functions. This role is the subject matter expert (SME) on U.S. healthcare laws, FDA promotional regulations and industry codes to enable legal and compliant pre-launch, launch and ongoing commercial and medical activities. This role partners with Compliance to ensure that the Company's U.S. compliance program remains risk-based, fit-for-purpose and aligned with our corporate values, while supporting cross-functional teams through advisory responsibilities, training and policy development. The ideal candidate will combine a strategic and seasoned mindset with "hand's-on" tactical and operational excellence. In-house biotech experience strongly preferred. This position will report to the Chief Legal Officer and be based in our Waltham, MA headquarters location.
Key Responsibilities:Commercial & Medical Affairs Legal Lead- Serve as key legal partner and SME to commercial and medical teams
- Provide practical legal advice on pre-launch activities and launch strategy, including medical (e.g., MSL activities and programs), disease awareness, sales, marketing (brand messaging, activities and campaigns), marketing analytics, patient advocacy programs, advisory boards, incentive compensation for commercial personnel and other business activities
- Counsel market access on pricing, reimbursement, distribution and contracting structures; advise on payer engagement issues including PIE and FDAMA 114; draft and lead the development of market access and patient support agreements; advise patient support team on legal issues related to patient support and hub services
- Act as Legal representative reviewing content and messaging on Promotional Review Committee, Medical Legal Regulatory (Medical) Review Committee, Publications Review Committee, ISR reviews, grants and sponsorships committees and similar bodies
- Training of applicable personnel
- Oversee outside counsel; conduct and respond to diligence for financings, business development activities and the like as needed; and review other external corporate content such as press releases
Compliance Program Support- Provide thought partnership to Compliance to advise commercial, medical, and advocacy teams on compliance obligations
- Partner with Compliance to evolve the U.S. compliance program consistent with company size and scope and aligned with company values
- Partner with Compliance to coordinate training activities including legal and compliance responsibilities, ethics, policies and procedures
- Support development and enhancement of compliance policies and SOPs related to AKS, FCA, and industry codes
Cross-Functional Legal Support- Coordinate legal support as a cross-functional partner with business and Legal and Compliance colleagues
Other duties and responsibilities as assignedQualifications:- JD required with 12+ years of relevant legal experience in the biopharmaceutical industry (biotech experience strongly preferred; experience with compliance helpful)
- Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG guidance, and industry codes, and ability to stay current on evolving trends and enforcement priorities
- 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 (experience building for a company's first U.S. launch is preferred)
- 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; comfortable working in a demanding start-up culture with evolving processes; flexible and able to adapt to new situations as the business demands
#LI-Hybrid
The position is eligible for a competitive compensation and benefits package.
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $272,000 to $340,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas' competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.
