Senior Vice President of Clinical Operations
2 weeks ago
Key Responsibilities
In this essential position, you will have the chance to influence clinical development across various Therapeutic Areas.
Position Overview
Immix Biopharma is in search of a driven physician leader with extensive drug development experience to take on the role of Vice President of Clinical Development. This pivotal position is part of a dynamic clinical development team focused on autoimmune and oncology sectors. You will report directly to the executive leadership and play a crucial role in shaping our portfolio strategy for autoimmune and oncology indications while defining the overarching clinical development framework. Your role will involve collaboration with clinical sites, Contract Research Organizations (CROs), investigators, and advisory panels. You will work closely with internal teams, including clinical, translational, and scientific divisions.
This position is strategic, requiring high-level interactions with leadership while also necessitating hands-on involvement at the program level. You will oversee study execution, program initiatives, and clinical development strategies across the entire portfolio.
The ideal candidate will possess profound expertise in both early and late-stage clinical development, along with a proven history of advancing precision medicines from initial research to regulatory approval, demonstrating strong scientific integrity and a comprehensive understanding of target and disease biology.
- As a vital member of the Development Leadership Team, you will provide scientific, clinical, and product development guidance for programs within the Immix Biopharma portfolio.
- Offer indirect leadership to a cross-functional team of physicians, clinical scientists, and other development professionals.
- Bring specific therapeutic area knowledge to enhance innovation and efficiency in clinical trial design and execution.
- Oversee the creation and ongoing refinement of clinical development plans for the portfolio from Investigational New Drug (IND) applications to Proof of Concept (POC) and New Drug Applications (NDA).
- Contribute significantly to IND, NDA, and Premarket Approval (PMA) submissions by managing medical documentation and actively participating in regulatory meetings.
- Serve as the clinical lead for early development studies, including study design, protocol development, regulatory documentation, CRO engagement, study initiation, investigator interactions, data monitoring, health authority communications, analyses, and study reporting.
- Establish and nurture relationships with investigators and thought leaders in close collaboration with the Medical Affairs team.
- Assist in scientific advisory boards, conference participation, external collaborations, and partnerships.
- Provide medical, disease-specific, and developmental insights into specific research initiatives or broader research programs.
Qualifications
- Medical Doctor (MD/MBBS/DO) degree with fellowship training in rheumatology, medical hematology, or oncology from a US-accredited institution.
- A minimum of three (3) years of clinical development experience within a large pharmaceutical organization.
- Possess a deep understanding of autoimmune diseases and oncology, including drug development frameworks, clinical pharmacology, and regulatory approaches.
- Exceptional interpersonal and communication skills, both written and verbal, with the ability to convey complex information clearly and concisely.
- Proficient in fostering collaboration, achieving results, influencing stakeholders, and resolving conflicts across various internal and external parties.
- Comprehensive knowledge of phase I-IV drug development processes.
- A passion for clinical development and precision medicine, with strong connections to external experts and credible advisors in the oncology field.
- Proven ability to build and maintain key partnerships and collaborations with the external scientific community, including academia, governmental bodies, nonprofit organizations, and CROs.
Additional Information
- Flexible working environment.
- Competitive compensation package, including an annual company bonus.
- Eligibility for an option grant to acquire shares in Immix Biopharma, Inc.
Your information will be kept confidential in accordance with EEO guidelines.
Immix Biopharma, Inc is dedicated to fostering a diverse workforce that reflects the communities we serve. We believe that diverse and inclusive teams create a stronger and more innovative organization. Therefore, all qualified applicants will be considered for employment without regard to race, religion, color, gender, sexual orientation, age, disability status, marital status, or veteran status.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering cell therapies for AL Amyloidosis and other autoimmune conditions. Our leading cell therapy, NXC-201, is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy currently undergoing evaluation in the Phase 1b/2 NEXICART-1 clinical trial. NXC-201 aims to be the first "Single-Day CRS" CAR-T, potentially allowing for quicker patient recovery and supporting expansion into autoimmune indications. NXC-201 has received Orphan Drug Designation (ODD) from the FDA for both AL Amyloidosis and multiple myeloma, as well as ODD from the European Commission (EMA) for multiple myeloma and AL Amyloidosis.
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