Associate Director, Clinical Development

Immix Biopharma (Nasdaq: IMMX); Los Angeles (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Immix Biopharma is seeking an Associate Director, Clinical Development in Los Angeles to lead protocol drafting for new indications and interpret complex trial data. You will coordinate cross-functional, global collaborations and communicate findings to stakeholders, advancing AL amyloidosis programs.

The role requires deep experience in designing multicenter trials, regulatory interactions, and adherence to GCP and FDA guidelines.

Qualifications

• Multi-year experience designing clinical trials and drafting US FDA protocols.
• Experience conceptualizing, designing and conducting complex global trials in Ph1b to registrational stages.
• Strong knowledge of GCP, FDA regulations and international guidelines.

Responsibilities

• Lead drafting of clinical trial protocols for new indications.
• Support cross-functional and global collaborations to integrate scientific and regulatory input into development programs.
• Interpret and communicate clinical trial data.
• Develop key opinion leaders and present at advisory boards and scientific meetings.
• Identify new clinical research opportunities.

Skills

Clinical trial design

US FDA knowledge

Global trial execution

GCP & regulatory familiarity

IND/BLA experience

Education

MD or equivalent

PhD

PharmD

Bachelor’s or higher degree

Job description

Associate Director, Clinical Development

Our Values

What You Will Do

• 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 presentation at advisory boards, key scientific meetings and external committee meetings
• Identify new clinical research opportunities

What We Look For

• Multi-year experience designing clinical trials and drafting protocols for US FDA
• In-depth understanding of and proven success in how to conceptualize, design, and conduct 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 of regulatory interactions, authoring filing IND or BLA experience
• MD (or equivalent), PhD, PharmD or other Bachelors/higher degree

Who we are …

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.