Senior Scientist, Biomarkers

Prime Medicine • Cambridge, MA

2d

About The Position

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

Requirements

• 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.
• 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.
• Strong data analysis skills and ability to interpret complex biomarker datasets.
• Experience contributing to regulatory submissions (INDs, briefing documents, clinical study reports) preferred.
• Ability to critically evaluate assay performance and scientific rigor.
• Demonstrated ability to manage external vendors and timelines.
• Strong time and resource management skills.
• Ability to operate independently while thriving in a collaborative, cross-functional environment.
• Excellent written and verbal communication skills.

Nice To Haves

• Experience in rare disease programs.
• Experience with genetic medicine or gene editing platforms.
• Experience supporting first-in-human studies.
• Exposure to multiplexed, LC/MS-based, or advanced molecular biomarker platforms.

Responsibilities

• 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).
• 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.
• 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.
• 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.
• 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.

Benefits

• Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.
• Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree