Senior Counsel, Commercial Legal & Compliance

Compass Therapeutics, Inc. was founded in 2014 and is headquartered in Boston, MA. We are an oncology-focused biopharmaceutical company discovering and developing proprietary antibody-based therapeutics to treat multiple diseases. Our robust pipeline currently includes four clinical assets spanning all phases of studies, novel mechanisms of action, and first-in-class or best-in-class potential across multiple tumor types. Our lead clinical-stage asset, tovecimig, has completed a randomized late-stage biliary tract cancer study and we are preparing for a BLA submission. We are now at an exciting inflection point as we build out a commercial organization to support our first product launch. This is a unique and pivotal moment to join us and help make a meaningful impact on patients' lives. For more information, visit www.compasstherapeutics.com.

Position Overview:

Our Legalteam is seeking a commercially experienced and business-minded Senior Counsel, Commercial Legal & Compliance reporting directly to our General Counsel. This high-impact role will lead the development of our commercial legal and compliance capabilities and framework in preparation for a BLA submission and potential first product launch. This role will partner cross-functionally to enable compliance commercialization while mitigating nuanced legal and regulatory risk specific to the life sciences industry. The ideal candidate is a pragmatic problem-solver who can balance legal rigor with business practicality in a fast-moving environment. We seek candidates who appreciate our unique opportunity to impact patients in need of new therapeutic options.

This position is on-site at our office in Brighton, MA with an expectation of 4 days/week in the office.

Responsibilities:

• Lead the development and implementation of the company's commercial legal and healthcare compliance infrastructure in advance of launch
• Serve as primary legal advisor to the Commercial and Medical Affairs functions through commercial buildout and commercial launch activities, ensuring milestones are met within compliance standards
• Design, implement, and manage a robust healthcare compliance program in preparation for commercial launch, including policies, procedures, training, and monitoring activities
• Structure and implement a cross-functional promotional review and approval process, encompassing review of pre-approval communications, promotional materials, and other external content, all aligned with FDA promotional regulations and industry standards
• Build strong relationships and lead strategic planning to successfully collaborate and execute across teams: sales, marketing, market access, supply and distribution, pricing, and reimbursement
• Represent the Legal function on future brand, product, and launch teams in collaboration with internal and external stakeholders, including structuring, drafting, and negotiating complex commercial agreements
• Collaborate closely with medical organization, including medical affairs, to provide practical advice on strategies, plans, and tactics for scientific exchange and field activities
• Proactively assess risks and advise on our compliance with applicable healthcare laws and regulations, including FDA and OIG guidance, fraud and abuse laws, PhRMA Code, data privacy and security laws, and transparency and price reporting requirements
• Act as the primary legal resource on interactions with HCPs, including FMV and needs assessments, advisory board structuring, and consultant and speaker management
• Build and oversee a robust transparency, aggregate spend tracking, and reporting program
• Develop innovative legal solutions in a fast-paced environment and across a range of disciplines
• Draft, negotiate, and advise on a broad range of sophisticated commercial contracts and transactions, including product sales, supply and distribution, master services, software and technology, licensing, and strategic collaborations
• Support business development activities, including strategic collaborations and partnerships
• Contribute to broader corporate legal needs as we evolve and expand our operations, including managing outside counsel where specialized advice is required

Qualifications:

• Bachelor's degree, J.D. from a top law school, and active bar membership in at least one U.S. jurisdiction; current license to practice in Massachusetts preferred
• 7+ years of relevant legal experience representing clients in the life sciences industry (in-house or at a law firm); in-house pharmaceutical or biotechnology experience preferred
• Deep knowledge and understanding of U.S. healthcare laws and regulations, including the Anti-Kickback Statute, False Claims Act, FDA promotional regulations, OIG guidance, PhRMA Code, Sunshine Act, HIPPA, and various state analogues; familiarity with government pricing programs (Medicaid Best Price, AMP, 340B) is nice to have
• Hands-on experience building comprehensive compliance infrastructure, including codes, policies, procedures, and other key components thereof, in a commercial setting
• Prior experience launching oncology products or specialty pharmaceuticals preferred, with a deep understanding of biopharmaceutical legal and regulatory risks, with MLR/PRC expertise
• Experience drafting and negotiating complex commercial agreements in the life sciences space
• Ability to communicate effectively and clearly to a diverse set of audiences ranging from junior employees to senior executives to the board of directors
• Strong analytical and problem-solving skills; ability to think creatively and develop innovative legal strategies; adaptability and nimbleness
• Intellectual curiosity and a passion for science