Senior Scientist, Safety Assessment

About the role

The Senior Scientist, Safety Assessment drives the design and execution of nonclinical safety studies that enable IND progression for Prime Medicine's gene editing programs. This role owns hands-on assay execution and troubleshooting for liver-targeted therapeutics within a cross-functional discovery environment. The hire will actively participate in study oversight at contract research organizations while analyzing complex data sets and preparing regulatory study reports. Collaboration with Pharmacology, DMPK, and delivery platform teams is central to evaluating emerging targets and platform components. The position requires scientific leadership to identify potential safety findings and define appropriate next steps for pipeline advancement. Success in this role ensures that studies comply with regulatory guidelines and internal quality standards across in-house and CRO activities. The Senior Scientist will provide domain expertise to support program progression through early development stages in a fast-paced matrixed organization.

Key facts

What you'll do

Contribute to nonclinical safety activities as part of cross-functional Discovery and Development project teams, supporting program progression through IND-enabling stages.

Design, execute, and troubleshoot nonclinical safety studies, including hands-on laboratory work (~30%) to support assay development, data generation, and issue resolution.

Support the execution and oversight of nonclinical safety studies (GLP and non-GLP) at CROs, including active involvement in troubleshooting assay and study-related challenges.

Analyze and interpret study data with guidance and contribute to the preparation of study reports and supporting documents for regulatory submissions.

Collaborate with Pharmacology, DMPK, and other functions to support exploratory studies (e.g., exploratory toxicology, DMPK, biodistribution, and delivery platform evaluation).

Contribute to evaluation of new delivery approaches, Lipid and RNA components, and emerging targets to support pipeline expansion.

Assist in identifying potential safety findings and contribute to discussions on data interpretation and next steps.

Ensure studies and internal activities are conducted in compliance with regulatory guidelines and internal standards.

Perform study execution and data analysis activities with rigorous attention to accuracy, consistency, and documentation.

Apply technical expertise to interpret complex biological and toxicological data sets in the context of gene editing therapeutic programs.

Partner with external CROs to resolve scientific or operational issues that may impact study timelines or data quality.

Support the generation of high-quality data packages that meet regulatory expectations for investigational new drug applications.

Requirements

Ph.D. in toxicology or a related discipline with 6+ years of biopharmaceutical industry experience in nonclinical safety assessment, or an M.S. in toxicology or a related field with 10+ years of experience in nonclinical safety assessment.

Demonstrated ability to work independently while providing domain expertise and leadership within cross-functional teams.

Strong scientific judgment and leadership to evaluate study outcomes and guide decision-making in a fast-paced, matrixed environment.

Experience in large molecule therapeutic development and a background in immunology is highly desirable.

Understanding of toxicology principles, nonclinical safety evaluation, and the drug development process.

Familiarity with interpreting toxicology data and contributing to technical and scientific reports for regulatory contexts.

Proven capacity to manage multiple priorities and meet deadlines in a dynamic biotechnology setting.

Commitment to maintaining high standards of data integrity, compliance, and documentation for all study activities.

Preferred Qualifications

Ph.D. in toxicology or a related discipline with 6+ years of biopharmaceutical industry experience, or M.S. in toxicology or a related field with 10+ years of relevant biopharmaceutical industry experience supporting drug development in nonclinical safety/toxicology.

Experience in large molecule therapeutic development, along with a background in immunology, is desirable.

Understanding of toxicology principles, nonclinical safety evaluation, and the drug development process, with some experience interpreting toxicology data and contributing to technical and scientific reports.

Demonstrates strong scientific judgment and leadership with the ability to evaluate study outcomes and guide decision-making.

Nice to have

Experience with liver-targeted therapeutics and relevant delivery platforms.

Knowledge of RNA and lipid nanoparticle characterization and safety assessment strategies.

Familiarity with gene editing modalities and their associated safety considerations.

Practical notes

This role is full-time.

Candidates must be authorized to work in the United States without sponsorship for this position.

Relocation is not sponsored by the company.