Associate Director, Clinical Development

About the Role

Immix Biopharma, Inc. (ImmixBio) is a global leader in AL Amyloidosis, developing NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy with a "digital filter" designed to filter out non-specific activation. 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 received Breakthrough Therapy Designation (BTD), Regenerative Medicine Advanced Therapy (RMAT) from the US FDA, and Orphan Drug Designation (ODD) from both the FDA and EMA.

Responsibilities

• Lead drafting of clinical trial protocols for new indications
• Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s)
• Interpret and communicate clinical trial data
• Develop key opinion leaders and make scientific presentations at advisory boards, key scientific meetings, and external committee meetings
• Identify new clinical research opportunities

Requirements

• Multi-year experience designing clinical trials and drafting protocols for US FDA
• In-depth understanding of and proven success in conceptualizing, designing, and conducting complex, global clinical trials in all phases of development, especially Ph1b and 2/3 registrational trials
• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
• Prior experience with regulatory interactions, authoring IND or BLA filings
• MD (or equivalent), PhD, PharmD, or other Bachelor’s/higher degree

Our Values

• Integrity
• Intelligence
• Initiative