Immix Biopharma, Inc. Vice President, Legal & Compliance Los Angeles, CA · Full time Company website

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Immix Biopharma

Los Angeles, CA / Hybrid

Vice President, Legal & Compliance 

Position Summary

We are seeking an strategic, experienced, and hands-on Vice President, Legal & Compliance as we advance NXC-201 toward potential FDA approval, BLA submission, and commercial launch. We are moving with urgency towards a commercial US launch and need a legal leader who can build the legal and compliance function from the ground up and who has guided biopharmaceutical companies through the clinical-to-commercial transition.

What You Will Do

• Design and oversee a corporate compliance program for a newly commercial public biopharmaceutical company, including commercial compliance policies and procedures, fraud and abuse prevention (Anti-Kickback Statute, False Claims Act), HCP engagement guidelines, transparency and aggregate spend reporting, and FCPA compliance
• Establish and lead the promotional review process (PRC/MLR) for all advertising, promotional, and medical affairs materials to support compliant product communications from pre-launch through commercialization
• Direct legal strategy for the commercial organization in connection with product launch, including market access strategy, pricing, distribution channel agreements, payor contracting, and commercial partnership arrangements
• Support clinical operations, regulatory affairs, and medical affairs functions, including clinical trial agreements, investigator site agreements, regulatory strategy, and medical education and advisory board engagements
• Oversee contract lifecycle management and lead negotiation of complex agreements across commercial, clinical, and corporate functions

Qualifications

• J.D. from an accredited law school
• 10+ years of progressive legal experience, with a substantial portion in the biopharmaceutical or biologics industry
• Demonstrated experience guiding a biopharmaceutical company through the clinical-to-commercial transition, including product launch legal strategy and compliance program buildout
• Deep knowledge of pharmaceutical commercial compliance, including Anti-Kickback Statute, False Claims Act, Sunshine Act / transparency reporting, and promotional review
• Experience with FDA regulatory matters, clinical trial operations, and R&D legal support in a biologics or pharmaceutical environment
• Experience at an AM Law 100 or equivalent law firm preferred
• Experience with cell therapy, gene therapy, or advanced biologics preferred

About Immix Biopharma

Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a global leader in 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 potentially 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.