Chief Medical Officer, Vice President Clinical Development

About the role

Immix Biopharma is seeking a motivated physician leader with drug development experience to serve as Vice President of Clinical Development. This leadership role sits within a growing clinical development organization in the autoimmune and oncology space. You will report to the C-Suite and directly influence the development of our portfolio in autoimmune and oncology indications, helping to define the broader clinical development strategy. You will interface with sites, CROs, investigators, and advisors, and collaborate internally with clinical, translational, and scientific groups.

This role is strategic with key interactions at the highest leadership levels and will also require you to be hands-on at the program level. You will be responsible for study conduct, program activities, and clinical development plans across the portfolio.

Responsibilities

• Provide scientific, clinical, and product development leadership and support for development programs across the Immix Biopharma portfolio as a key member of the Development Leadership Team.
• Provide indirect leadership to a cross-functional, matrix team of physicians, clinical scientists, and other development teams.
• Offer specific therapeutic area expertise to enhance innovation and efficiency in clinical trial design and execution.
• Responsible for the generation and continual refinement of the clinical development plans for Immix’s portfolio from IND to POC to NDA.
• Provide key contributions to IND, NDA, and PMA submissions via overseeing medical documentation and active participation in meetings with regulatory agencies.
• Serve as clinical lead for early development study conduct, including study design, protocol writing, regulatory documents, CRO interactions, study start-up, investigator interactions, data monitoring, health authority interactions, analyses, and study reports.
• Establish and develop relationships with investigators and thought leaders in close collaboration with the Medical Affairs function.
• Assist in scientific advisory boards, conference activities, external collaborations, and partnerships.
• Provide medical, disease-specific, and development perspective into specific research programs or broader research initiatives.

Requirements

• Medical Doctor (MD/MBBS/DO) degree with fellowship training in rheumatology/medical hematology/oncology at a US-accredited program.
• Three (3) or more years of clinical development experience at a large pharmaceutical company.
• Deep knowledge and understanding of autoimmune diseases and oncology, including drug development paradigms, clinical pharmacology, and technical, business, and regulatory approaches.
• Outstanding interpersonal and communication skills, both written and oral, with the ability to communicate complex information clearly and succinctly.
• Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external stakeholders.
• In-depth understanding of phase I-IV drug development.
• Passion for clinical development and precision medicine, with strong connections to external experts and highly credible advisors in the oncology space.
• Talent and ability in forging and nurturing key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations, and CROs.

About Immix Biopharma

Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is the global leader in relapsed/refractory AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system produces toxic light chains, clogging 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” 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 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.