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Job description
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 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 (NCT ), 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.
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Worksite address
los angeles, CA, 90079, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.