Senior Scientist, Biomarkers

Company Overview:

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 investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit www.primemedicine.com.

We are seeking a Senior Scientist, Biomarkers

Key Responsibilities

Biomarker Strategy & Scientific Leadership

• Lead fluid biomarker strategy for clinical programs, ensuring alignment with clinical objectives, regulatory expectations, and translational hypotheses.
• Design and oversee development, qualification, and validation of biomarker assays at CROs and external laboratory partners.
• Provide scientific oversight for assay selection, fit-for-purpose validation, and performance monitoring.
• Contribute to clinical protocol development, statistical analysis plans, and regulatory documents (e.g., INDs, briefing books).

Assay Development & Validation

• Direct development and validation/qualification of blood-based and other fluid biomarker assays (e.g., protein, enzymatic, molecular assays).
• Ensure assays are developed under appropriate regulatory frameworks (GLP/GCLP/CLIA as applicable).
• Evaluate assay performance characteristics including sensitivity, specificity, precision, robustness, and stability.
• Troubleshoot assay performance issues and implement corrective actions.

Clinical Study Execution

• Partner closely with clinical operations and sample management teams to ensure seamless biomarker sample collection, handling, and analysis.
• Collaborate with peers responsible for immunogenicity and PK assays to ensure integrated PK/PD and biomarker analysis.
• Oversee data generation timelines, budgets, and vendor performance.
• Lead scientific review and interpretation of biomarker data to support internal decision-making.

Cross-Functional Collaboration

• Work closely with Clinical Development, Regulatory, Biostatistics, CMC, and Research teams.
• Contribute to cross-program biomarker governance and best practices.
• Represent the Biomarkers group in cross-functional team meetings and external vendor discussions.

Data Analysis & Interpretation

• Perform and/or oversee robust statistical and scientific analysis of biomarker data.
• Integrate biomarker findings with clinical endpoints and PK data.
• Prepare high-quality summaries and presentations for internal governance and external regulatory interactions.

 

Qualifications

Education & Experience

• PhD in Immunology, Molecular Biology, Biochemistry, Translational Medicine, or related discipline with 4+ years of industry experience; or
• MS with 8+ years of relevant industry experience.
• Demonstrated experience supporting clinical-stage programs.

Technical Expertise

• Strong experience in assay development and fit-for-purpose validation (protein, enzymatic, or molecular assays).
• Hands-on experience managing assay development at CROs and external laboratories.
• Deep understanding of GCLP/GLP principles and regulatory expectations for clinical biomarker assays.
• Experience with blood-based biomarker assays required.
• Familiarity with PK/PD concepts and translational biomarker strategy strongly preferred.

Scientific & Analytical Skills

• Strong data analysis skills and ability to interpret complex biomarker datasets.
• Experience contributing to regulatory submissions (INDs, briefing documents, clinical study reports) preferred.
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