• Draft, review, and negotiate a broad range of commercial agreements, including: - Commercial site agreements - Vendor and supplier agreements - Distribution, logistics, and manufacturing support agreements - Consulting, advisory board, patient advocacy and speaker agreements - Overflow support for clinical, research, and medical affairs-related contracts and confidentiality agreements • Develop and maintain contract templates and playbooks to support efficient scaling. • Provide legal guidance to commercialization team including marketing, market access, commercial operations, patient advocacy and medical affairs teams on promotional activities, disease education, and engagement with healthcare professionals. • Provide legal guidance on go-to-market strategies for a first-in-class or novel cell therapy. • Support legal aspects of sales, distribution, and commercialization models. • Advise on pricing, contracting, and reimbursement-related legal considerations in coordination with internal stakeholders. • Review and advise on promotional materials and commercial communications in coordination with medical and regulatory teams. • Advise on healthcare compliance matters and regulations impacting commercial activities, including: - FDA/EMA (including promotional and labeling requirements) and FTC regulations - Anti-Kickback Statute (AKS), False Claims Act (FCA), and other applicable anti-kickback, anti-corruption, and fraud and abuse laws - Sunshine Act and other transparency and reporting obligations (e.g., EU disclosure rules) - PhRMA Code and applicable state laws • Partner with compliance to support training, policies, and internal review processes for commercial and medical materials. • Provide guidance on data privacy and protection matters, including HIPAA and GDPR, particularly in relation to: - Patient support programs - Registries and real-world evidence initiatives - Data-sharing and vendor agreements • Assist with legal due diligence and integration activities related to partnerships or acquisitions. • Identify legal and business risks and propose practical, compliant solutions aligned with company objectives. • Collaborate closely with internal stakeholders to streamline contracting processes and improve operational efficiency.