Associate Director/Director, Clinical Biomarkers
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.
Prime Medicine is currently progressing a diversified portfolio of eighteen programs initially focused on genetic diseases with a fast, direct path to treating patients or with a high unmet need because they cannot be treated using other gene-editing approaches. Over time, the Company intends to maximize Prime Editing’s therapeutic potential and advance potentially curative therapeutic options to patients for a broad spectrum of diseases. For more information, please visit www.primemedicine.com.
Prime Medicine is seeking an experienced clinical biomarker professional to oversee clinical biomarker assay development and sample assessment at Prime for our late preclinical programs. This person will be a key contributor to the clinical biomarker plan development for all our programs, and will be responsible for plan implementation, including identification of appropriate vendors/platforms, establishment of assays and oversight of data generation and quality. Because Prime Medicine is a precision gene editing technology additional focus on patient selection genotyping Biomarkers will be required. The individual will ensure appropriate data analysis and interpretation to support decision making for clinical-stage programs and work cross functionally to achieve objectives. The individual will also serve as a resource for discovery- and translational-stage research scientists as a part of a newly formed Translational Medicine group based in Research, and report to the Translational Sciences Head. The individual will also be involved with the identification of potential biomarkers and formulation of development stage-appropriate biomarker plans.
- Collaborate cross functionally with nonclinical, translational and clinical functions to support clinical biomarker plans, and then lead implementation of clinical biomarker plans for Prime late-pre-clinical programs and future clinical programs;
- Identify robust assay platforms and vendors suitable for clinical sample analysis;
- Support development and lead assay transfer of clinical biomarkers to appropriate vendors; oversee vendor assay development work, fit-for-purpose validation, and report generation;
- Oversee external CRO activities including assay development, validation and sample testing for generation of biomarker data to support INDs/CTAs and BLAs;
- In collaboration with clinical operations, ensure clinical sample collection and analysis proceeds smoothly, confirm the quality of the data generated, and oversee generation of sample analysis reports in accordance with agreed timelines;
- Collaborate with the subject matter experts, biostatistics, programming and data management to ensure appropriate data analysis, reporting and interpretation of raw biomarker data, PD and PK/PD analyses;
- Collaborate with discovery, research and translational functions on proactive biomarker planning and generation of IND-enabling non-clinical data for early-stage compounds;
- Participate in planning and authoring of regulatory and clinical documents, posters and publications; and
- Serve as a resource for development of biomarker plans and assays for potential and late-stage discovery and early development candidate-stage programs.
- Advanced degree (Ph.D. or equivalent) in the biological or medical sciences. M.S. and B.S. degrees will be considered based on relevant industry experience. Minimum of 5+ years of industry or clinical laboratory experience in biomarker assays; method development, transfer, assay qualification, validation and implementation in clinical trials, application of a broad range of molecular technologies (e.g. NGS, FACS, IHC, ELISA and other ligand-binding methods) and cell-based ex vivoassays with associated data analysis;
- A background in rare diseases or genetic therapies is preferred;
- Experience in novel liquid biomarker assessments and/or CDx development is a plus;
- Assay problem solving and analytical skills; ability to resolve technical issues that may arise during method development, assay validation and sample assessment
- Knowledge in the selection and oversight of assay vendors to support national and global clinical trials;
- Knowledgeable about requirements for fit-for-purpose, GLP-compliant or CLIA compliant assay validation and experience applying these standards appropriately based on development stage and biomarker status in the program;
- Familiarity with submission-level reporting and data quality standards;
- Familiarity with genomic and pathology assays and methodologies is desired;
- Excellent collaboration skills; and
- Demonstrated success working in a cross-functional matrixed setting.
Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.
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