Chief Medical Officer, Vice President Clinical Development

Immix Biopharma (Nasdaq: IMMX); Los Angeles (CA); On-site; USD 300,000 - 420,000; Full time

Job summary

Immix Biopharma seeks a physician leader to serve as Vice President Clinical Development and Chief Medical Officer. This role shapes autoimmune and oncology programs, interfaces with CROs, investigators and regulatory bodies, and guides IND-to-POC-to-NDA plans.

The ideal candidate has deep early-to-late stage experience, a track record of advancing precision medicines, and strong scientific rigor with disease biology insight.

Qualifications

• MD/MBBS/DO with fellowship training in medical hematology/oncology at a US-accredited program.
• Five or more years of FDA-facing clinical development experience.
• Deep knowledge of autoimmune diseases and oncology with drug development paradigms.

Responsibilities

• Provide scientific, clinical and product development leadership for development programs.
• Lead cross-functional teams and interfacing with regulatory agencies.
• Develop and refine clinical development plans from IND to NDA.
• Contribute to trial design, regulatory documents and study conduct.

Skills

Leadership

FDA experience

Medical communication

Education

MD/MBBS/DO with fellowship in hematology/oncology

Job description

Chief Medical Officer, Vice President, Clinical Development

Immix Biopharma is seeking a motivated physician leader with drug development experience to serve as Vice President 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 and help to define the broader clinical development strategy. You will interface with sites, CROs, investigators and advisors. You will 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.

The ideal candidate will have deep expertise in early to late-stage clinical development and a demonstrable track record of advancing precision medicines from bench to bedside to approval with strong scientific rigor and a thorough understanding of target and disease biology.

What You Will Do

• As a key member of the Development Leadership Team, you will be responsible for providing scientific, clinical and product development leadership and support for development programs across the Immix Biopharma portfolio.


• Provide indirect leadership to a cross-functional, matrix team of physicians, clinical scientists and other development teams


• Provide 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 Bicycle’s portfolio from IND to POC to NDA


• Provide key contribution to IND, NDA, PMA submissions via overseeing medical documentation and active participation in meetings with regulatory agencies


• 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, 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

Qualifications

• Medical Doctor (MD/MBBS/DO) degree with fellowship training in medical hematology/oncology at a US-accredited program


• Five (5) or more years of FDA-facing clinical development experience


• Possess a 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 and 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


• You are passionate about clinical development and precision, and are well connected to external experts and highly credible advisors in the oncology space


• You have 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, 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 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.