Cell Therapy Clinical Operations (Associate Director)

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

Job summary

Immix Biopharma, Inc. is seeking an Associate Director, Cell Therapy (CAR-T) Clinical Operations to manage day-to-day study activities, budgets, and timelines across one or more trials in compliance with GCP and regulatory requirements.

You will lead site management, develop critical study documents, and mentor CROs, CRAs, and site staff while ensuring quality and timely delivery of trial milestones in the CAR-T program.

Qualifications

• 3–5+ years of cell therapy clinical operations experience.
• Bachelor's degree or higher in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent).
• Strong knowledge of the clinical research process, including regulatory requirements.
• Exceptional project management, organizational and problem-solving skills.
• Collaborative, team-oriented mindset with eagerness to learn.
• Excellent written and verbal communication skills, able to convey complex ideas to study personnel.

Responsibilities

• Oversee scope, quality, timelines and budget for the early-stage CAR-T program, coordinating with internal leads, CROs and vendors.
• Lead site and study management activities, including start-up and development of critical study documents.
• Provide study-specific training and leadership to clinical research staff and CROs/CRAs/sites.

Skills

Cell therapy operations

Project management

Regulatory knowledge

Clinical trial design

Cross-functional collaboration

Communication skills

Education

Bachelor's or higher in natural/health sciences

Job description

Cell Therapy Clinical Operations (Associate Director)

Our 3 Core Values

• Integrity
• Initiative

How You Will Contribute to Advancing Clinical Trials

As our Associate Director, Cell Therapy (CAR-T) Clinical Operations, you will be accountable for the day-to-day study management and successful delivery of one or more clinical trials in accordance with the protocol, Immix SOPs and good clinical practices (GCP) and applicable regulations. By managing all aspects of the study including study start-up, budget and timeline, you'll play a critical role in advancing our life-saving therapies through the clinic and to patients who need it most.

What You'll Do

• For our Cell therapy (CAR-T) programs: Oversee scope, quality, timelines, and budget for our early-stage clinical trial, working with internal functional leads, CRO, and vendors to ensure overall project objectives are met.
• Lead site and study management activities, including study start-up and development of critical study documents.
• Provide study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel.
• Effectively communicate expectations to CRO, ensure appropriate site management, hold CRO accountable to timelines, and verify quality metrics.
• Anticipate obstacles or complex issues at the site, vendor, and study levels, and implements solutions.
• Proactively identify issues for escalation, participate in problem-solving and implementation of risk mitigation.
• Develop and ensure compliance with clinical monitoring plan; conducts or oversees co-monitor as needed for staff training and quality assurance (QA) purposes.
• Review the quality and integrity of the clinical data through review of electronic CRF data. Work with CRO/sites to resolve data queries.

Skills and Experience We Look For

• 3-5+ years of cell therapy clinical operations experience, including some experience with early phase research design.
• BA/BSc or higher (MD/PharmD/PhD) in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent)
• Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and regulatory requirements.
• Exceptional project management skills, organizational and problem-solving skills
• Eager to learn with a collaborative, team-oriented mindset.
• Excellent written and verbal communication skills with an ability to express complex ideas to study personnel at research and clinical institutions.

About Immix Biopharma, Inc.

Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a global leader in AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system that is 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 proprietary CD3ζ, CD8 hinge and binder "digital filter" 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.