Principal Scientist, Preclinical Toxicology - San Diego - BioLegacy Research

Description

Overview

About BioLegacy Research BioLegacy 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 BioLegacy'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

Position Summary The Principal Toxicologist serves as the primary scientific expert and client-facing lead within BioLegacy'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.

Key Responsibilities

• 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 Analysis and Reporting

• 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.

Regulatory and Quality Assurance

• Compliance Ensure all studies are performed in full compliance with FDA GLP regulations and applicable international guidelines (e.g., ICH, OECD, ISO
• 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 BioLegacy Research during audits and health authority inspections, providing scientific and regulatory justification for study decisions and data integrity.

Qualifications And Experience

• Education Ph.D. in Toxicology, Pharmacology, or a related scientific discipline.
• Experience Minimum of 5–7 years of experience designing, directing, and interpreting GLP toxicology studies, preferably within a CRO environment.
• Study Director Demonstrated record of serving as Study Director for multiple GLP studies, with completed studies that contributed to successful FDA submissions.
• Regulatory packages Experience preparing or contributing to IND/NDA/BLA nonclinical packages, with familiarity interacting with FDA or supporting sponsor regulatory strategy.
• Strategic perspective Proven ability to distinguish between CRO service execution and the strategic, milestone-driven requirements of drug development.
• Certification D.A.B.T. certification strongly preferred (or active pursuit/eligibility).

Technical Knowledge And Skills

• GLP knowledge Deep, practical understanding of GLP regulations and expectations across all stages of nonclinical toxicology.
• Program leadership Proven ability to lead complex study programs, ensuring cross-functional alignment, operational excellence, and scientific rigor.
• Communication Strong communication skills to foster client confidence, provide clear scientific guidance, and represent BioLegacy in a professional manner.
• multitasking Ability to manage multiple concurrent studies while maintaining high quality, accuracy, and regulatory compliance.

Why Join BioLegacy Research

At BioLegacy Research, you'll work with a team of accomplished scientists passionate about advancing global health through rigorous science and innovation. We offer a collaborative environment, opportunities for professional development, and the chance to make a tangible impact on the success of novel therapeutics.

Equal Opportunity Employer Statement

BioLegacy Research is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive workplace for all employees. All qualified applicants will receive consideration without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.