Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other autoimmune diseases. Our lead cell therapy is FDA IND cleared next generation CAR-T NXC-201, currently being evaluated in our ongoing Phase 1b/2 NEXICART-1 (NCT04720313) clinical trial, initiated in February 2021. NXC-201 has the potential to be the world’s first “Single-Day CRS” CAR-T (CRS median onset day 1, median duration 1 day), enabling the potential for a faster return home for patients and supporting ongoing expansion into autoimmune indications. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma, and ODD by the European Commission (EMA) in AL Amyloidosis. Learn more at www.immixbio.com and www.BeProactiveInAL.com.
Hybrid · Toronto
Support regulatory strategy and execution for clinical trials, including preparing, reviewing, submitting, and maintaining INDs, amendments, and other regulatory documents. Monitor regulatory changes, coordinate submission materials across internal and external teams, maintain regulatory records, and support audits and inspections.
Hybrid · Toronto
Coordinate clinical trial site start-up from identification through activation, including regulatory and ethics submissions, contract and budget negotiations, and essential document processing. Track timelines and start-up metrics, communicate with sites and cross-functional teams, and resolve or escalate issues to support on-time study launches.
