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Job description
Chief Medical Officer, Vice President, Clinical Development
Our Values
What You Will Do
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.
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 rheumatology/medical hematology/oncology at a US-accredited program
Three (3) or more years of clinical development experience at a large pharmaceutical company
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 (NCT ), 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.
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Worksite address
los angeles, CA, 90079, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.