Cell Therapy Clinical Operations (Associate Director)

About the role

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, good clinical practices (GCP), and applicable regulations. You will manage all aspects of the study, including study start-up, budget, and timeline, playing a critical role in advancing our life-saving therapies through the clinic and to patients who need them most.

Responsibilities

• 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 implement solutions.
• Proactively identify issues for escalation, participate in problem-solving, and implement risk mitigation.
• Develop and ensure compliance with clinical monitoring plan; conduct or oversee co-monitoring 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.

Requirements

• 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 the clinical research process, including working knowledge of all functional areas of clinical trials and regulatory requirements.
• Exceptional project management, 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, a devastating disease where the immune system produces toxic light chains that clog the heart, kidney, and liver, causing organ failure and death. Our lead candidate, NXC-201, is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy 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 the FDA and in the EU by the EMA.