Director, Corporate Counsel - Commercial

About the role

Corporate Counsel who will serve as a key legal partner to the commercial, medical affairs, and business development functions. This role will provide hands-on legal support across a wide scope, including commercial transactions, commercial site activation, compliance, and launch readiness.

• 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

Requirements

• Juris Doctor (JD) from an accredited law school
• Active license to practice law in at least one U.S. jurisdiction
• 7+ years of relevant legal experience, including in an in-house legal department in the biotech, pharmaceutical, or life sciences industry, with preference given to in-house experience at a cell therapy company, or law firm experience advising life sciences clients on commercial and transactional matters
• Experience supporting commercialization or launch activities strongly preferred, including experience drafting and negotiating complex commercial contracts including site agreements
• Familiarity with healthcare, pharmaceutical, biotech, or life sciences regulatory frameworks
• Knowledge of FDA promotional rules and healthcare compliance requirements

About Immix Biopharma

Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is the global leader in relapsed/refractory AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a registrational design. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA.