Principal Scientist, Preclinical Toxicology

Overview

About Bio Legacy Research Bio Legacy Research is a rapidly growing Contract Research Organization (CRO) dedicated to advancing preclinical drug development through scientific excellence, regulatory compliance, and collaboration. We partner with biotechnology and pharmaceutical companies to deliver high-quality GLP-compliant toxicology and safety assessment studies that support IND, NDA, and BLA submissions. Our mission is to accelerate the path from discovery to the clinic by ensuring scientific integrity, operational precision, and client confidence at every stage.

What We’re Hiring For We are seeking a highly experienced and forward-thinking Principal Toxicologist to join our scientific leadership team. This individual will play a central role in guiding Bio Legacy’s preclinical toxicology programs, ensuring the smooth execution of both in vivo and in vitro operations, and maintaining the highest scientific and regulatory standards.

The ideal candidate brings extensive hands-on Study Director experience, a proven track record of leading GLP studies to completion, and direct contributions to successful FDA submissions. They must also understand the nuance between CRO service delivery and sponsor-driven drug development goals, ensuring both operational excellence and strategic alignment with client objectives.

Position Summary The Principal Toxicologist serves as the primary scientific expert and client-facing lead within Bio Legacy’s preclinical research group. You will design, oversee, and interpret a broad range of GLP-compliant toxicology studies for pharmaceutical and biotechnology partners. You will also be responsible for leading multiple GLP studies as Study Director, ensuring data integrity, study execution, and scientific interpretation that support regulatory submissions including IND, NDA, and BLA.

The right candidate will have demonstrated success in navigating FDA expectations, preparing high-quality nonclinical packages, and contributing directly to regulatory approvals.

• Scientific Strategy and Client Partnership Serve as the principal scientific contact for clients, building long-term partnerships grounded in trust, transparency, and technical excellence.
• Client collaboration Collaborate with clients to understand program objectives, ensuring study designs reflect both regulatory expectations and drug development goals rather than generic service deliverables.
• Study design Develop scientifically rigorous and customized toxicology study designs that align with FDA guidance, ICH expectations, and clinical-stage needs.
• Study Oversight and Execution Function as Study Director for GLP toxicology studies, with responsibility for scientific conduct, data accuracy, final reporting, and regulatory readiness.
• Study Portfolio Maintain a strong portfolio of completed studies, demonstrating consistent success from protocol development through final reporting and client delivery.
• Cross-functional coordination Lead cross-functional coordination across in vivo and in vitro operations to ensure efficiency, consistency, and GLP compliance.
• Performance monitoring Monitor study performance proactively to identify risks, troubleshoot issues, and maintain timelines.

• Data interpretation Integrate toxicology, pathology, and clinical pathology data to generate meaningful, defensible conclusions for regulatory and scientific purposes.
• Reporting Prepare, review, and sign off on high-quality study reports that accurately reflect study outcomes and support regulatory submissions.
• Communication Communicate study findings clearly and confidently in client meetings, regulatory interactions, and technical presentations.

• Compliance Ensure all studies are performed in full compliance with FDA GLP regulations and applicable international guidelines (e.g., ICH, OECD, ISO 10993).
• Nonclinical submissions Support clients by authoring or contributing to nonclinical sections of IND, NDA, and BLA submissions, leveraging direct experience with FDA expectations.
• Audits Represent Bio Legacy Research during audits and health…