Sr. Scientist / Associate Director, Clinical Biomarkers (autoimmune Diseases)

About IGM Biosciences, Inc.

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites, compared to conventional IgG antibodies with only 2 binding sites. We have created unique IgM antibodies with high selectivity, affinity, and avidity that may redefine what is possible for therapeutic antibody medicines. We are committed to exploring how the unique structure and binding properties of the IGM antibody can improve outcomes for patients with these serious conditions. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology, immunology, and inflammation targets. For more information, please visit www.igmbio.com.   Imvotamab in Autoimmune and Inflammatory Diseases Imvotamab is a bispecific T cell engaging IgM antibody targeting CD20 and CD3 proteins. We believe that Imvotamab, with its 10 binding units for CD20, may successfully bind to CD20 expressing B cells with more power (avidity) compared to an IgG bispecific antibody with only one or two binding units for CD20. Our preclinical studies suggest that Imvotamab may offer the potential for deeper depletion of B cells, including those in low CD20 expressing cells, than currently approved antibody therapies. We are evaluating Imvotamab in Phase 1b clinical trials of Imvotamab in severe systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and idiopathic inflammatory myopathies (myositis).

Position Summary We are seeking a highly skilled, motivated, and creative Senior Scientist with deep knowledge of adaptive and innate immunity in inflammatory and autoimmune diseases and experience in clinical biomarker strategy, design, and execution, especially for T-cell engagers.

You should have a proven track record of biomarker assay development and be adept at working productively as part of a highly matrixed team with expertise in multi-parameter flow cytometry of primary human, non-human primate, and mouse immune cells. 

This role will require up to 30% lab work. You will be responsible for biomarker identification and characterization in translational research studies, implementation of state-of-the-art biomarker methods, and analysis and interpretation of biomarker data to guide early clinical development for autoimmune diseases.

This role reports to the Executive Director of Translational Research.

Responsibilities:

• Develop, qualify, and implement methods to identify candidate pharmacodynamic and predictive biomarkers in nonclinical models of autoimmune disease.
• Integrate and interpret preclinical biomarker data for successful cross-functional transfer to clinical biomarker colleagues.
• Collaborate with research and clinical development teams to develop clinical biomarker assays. Work closely with contract research organizations to transfer and qualify clinical biomarker assays.
• Accountable for biomarker strategy, delivery, communication, and follow-up.
• Generate and analyze diverse clinical biomarker data to derive scientific insights, validate them with experimental approaches, and translate them into development/diagnostic opportunities.
• Utilize your thorough understanding of autoimmune disease and drug target biology and provide disease area biomarker expertise.
• Present at cross-functional, internal team meetings and external conferences.
• Write biomarker sections of clinical protocols, reports, regulatory filings, and scientific publications.

Requirements:

• Level commensurate with experience.
• Senior Scientist/Associate Director: PhD with 8+ years, MS with 15+ years, or BS with 17+ years of experience in the biotech/biopharmaceutical setting (in a relevant scientific field e.g., immunology, molecular biology).
• 8+ years of industry experience in clinical biomarkers and drug development in autoimmunity/immunology.
• 8+ years of wet laboratory experience (up to 30% in the lab) with expertise and a strong understanding of immunoassays (i.e., flow cytometry), molecular biology, and cell biology techniques.
• Experience in clinical biomarker strategy, design, and execution, especially for T cell engagers, through CROs and internal resources would be a significant advantage.
• A deep understanding of human immunology and hands-on experience with preclinical immune-related models is required, along with the ability to distill complex issues, effectively visualize data, and develop hypotheses and direct analysis plans.
• Fluent in high dimensional flow cytometry analysis and interpretation.
• Key deliverables for this position will be the analysis of clinical biomarker datasets; thus, experience integrating biomarkers into clinical trials to enable decision-making is required.
• Familiarity and experience with big data analytics tools such as R, Python, Partek flow, Spotfire, or other data analysis programming is desirable.
• Demonstrated initiative and successful leadership/collaboration experience within cross-functional teams.
• Outstanding presentation and communication skills, including strong writing skills, as evidenced by publications, meeting abstracts, and drug development reports.
• Travel up to 15% will be required.
• Location: This position will be in Mountain View, CA, and will require working on-site three days per week.