Associate General Counsel (Commercial)

Key Responsibilities

• Commercial & Medical Affairs Legal Support
• 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
• Train 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

Qualification Requirements

• JD required with 12+ years of relevant legal experience in the biopharmaceutical industry (biotech preferred)
• 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
• Experience reviewing promotional and medical materials
• Experience supporting product launch planning and cross functional review committees (experience building for first US launch preferred)
• Strong business partnering skills with ability to balance risk and business goals
• Excellent 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