AD/Director, Clinical Biomarker Lead, Autoimmunity

Cullinan Therapeutics, Inc.(Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.Summary:Cullinan Therapeutics is seeking an experienced Biomarker and Translational Sciences leader to join the Translational Research team. A successful incumbent would help integrate basic science research, proteomics, genomics and informatics to advance clinical development of therapeutics for autoimmune diseases.Position Responsibilities:Design and implement clinical biomarker and exploratory translational strategies; adhere to clinical and regulatory submission protocols.Successfully manage CROs and establish relationships to develop biomarker assays, monitor assay qualification/validation at CROs, as well as biomarker testing in the clinic.Collaborate with clinical operations and the central lab to support clinical sample management and logistics.Perform integrative analysis of clinical biomarker data and drug response data for baseline and on-treatment biomarker discovery for clinical programs.Drive decisions to support PK/PD, immunogenicity, and predictive biomarker analysis in clinical studies.Ensure quality and timely submission of all clinical biomarker-related documents and materials for regulatory filings, including scientific advice filings, INDs, meeting briefing books, and other requests from global regulatory authorities.Candidate Requirements:Ph.D in Immunology or related field.5 or more years of industry (biotech/pharmaceutical) clinical biomarker experience in autoimmune diseases including but not limited to lupus and rheumatoid arthritis.Deep understanding of the pre-clinical, translational, and clinical stages of drug development in the immunology and/or autoimmunity field.Extensive working knowledge of biomarker assay development and the ability to critically evaluate emerging technologies in the clinical biomarker space.Experience in selection and management of external CROs.Hands-on experience with interpretation of flow cytometry data in clinical trials is required.Experience with analysis of clinical biomarker data on gene expression, multi-plex histology and soluble biomarkers is preferred.Experience leading within and collaborating effectively as a member of a cross-functional team.Demonstrable knowledge of appropriate quality standards including ICH/GCP, and global regulations.Excellent analytical skills, with an ability to communicate complex issues in a simple way.Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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