Zenas BioPharma

Vice President, Legal – Lead Commercial Counsel

Waltham, MA · Exec

Sponsorship not specified$272k-$340kDetected 50 days ago

ComplianceMarketing AnalyticsBusiness DevelopmentCompensationFDA RegulatoryAnimal StudiesLeadershipCommunication

About the role

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.
The ideal candidate will combine a strategic and seasoned mindset with "hand's-on" tactical and operational excellence.
This position will report to the Chief Legal Officer and be based in our Waltham, MA headquarters location.

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
Compliance Program Support

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
Strong business partnering orientation with ability to balance risk and business goals
JD required with 12+ years of relevant legal experience in the biopharmaceutical industry (biotech experience strongly preferred; experience with compliance helpful)
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)
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

In-house biotech experience strongly preferred.
JD required with 12+ years of relevant legal experience in the biopharmaceutical industry (biotech experience strongly preferred
experience with compliance helpful)

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, pati

Commercial & Medical Affairs Legal Lead
Serve as key legal partner and SME to commercial and medical teams
Counsel market access on pricing, reimbursement, distribution and contracting structures
Provide thought partnership to Compliance to advise commercial, medical, and advocacy teams on compliance obligations

This listing is sourced directly from Zenas BioPharma's careers page and normalized into a canonical job model.