BioLegacy Research · 20 hours ago
Principal Scientist, Preclinical Toxicology
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expBioLegacy Research is a rapidly growing Contract Research Organization dedicated to advancing preclinical drug development through scientific excellence. They are seeking a highly experienced Principal Toxicologist to guide preclinical toxicology programs, ensuring the execution of GLP-compliant studies and supporting regulatory submissions.
Biotechnology
Responsibilities
Serve as the principal scientific contact for clients, building long-term partnerships grounded in trust, transparency, and technical excellence
Collaborate with clients to understand program objectives, ensuring study designs reflect both regulatory expectations and drug development goals rather than generic service deliverables
Develop scientifically rigorous and customized toxicology study designs that align with FDA guidance, ICH expectations, and clinical-stage needs
Function as Study Director for GLP toxicology studies, with responsibility for scientific conduct, data accuracy, final reporting, and regulatory readiness
Maintain a strong portfolio of completed studies, demonstrating consistent success from protocol development through final reporting and client delivery
Lead cross-functional coordination across in vivo and in vitro operations to ensure efficiency, consistency, and GLP compliance
Monitor study performance proactively to identify risks, troubleshoot issues, and maintain timelines
Integrate toxicology, pathology, and clinical pathology data to generate meaningful, defensible conclusions for regulatory and scientific purposes
Prepare, review, and sign off on high-quality study reports that accurately reflect study outcomes and support regulatory submissions
Communicate study findings clearly and confidently in client meetings, regulatory interactions, and technical presentations
Ensure all studies are performed in full compliance with FDA GLP regulations and applicable international guidelines (e.g., ICH, OECD, ISO 10993)
Support clients by authoring or contributing to nonclinical sections of IND, NDA, and BLA submissions, leveraging direct experience with FDA expectations
Represent BioLegacy Research during audits and health authority inspections, providing scientific and regulatory justification for study decisions and data integrity
Qualification
Required
Ph.D. in Toxicology, Pharmacology, or a related scientific discipline
Minimum of 5–7 years of experience designing, directing, and interpreting GLP toxicology studies, preferably within a CRO environment
Demonstrated record of serving as Study Director for multiple GLP studies, with completed studies that contributed to successful FDA submissions
Experience preparing or contributing to IND/NDA/BLA nonclinical packages, with familiarity interacting with FDA or supporting sponsor regulatory strategy
Proven ability to distinguish between CRO service execution and the strategic, milestone-driven requirements of drug development
Deep, practical understanding of GLP regulations and expectations across all stages of nonclinical toxicology
Proven ability to lead complex study programs, ensuring cross-functional alignment, operational excellence, and scientific rigor
Strong communication skills to foster client confidence, provide clear scientific guidance, and represent BioLegacy in a professional manner
Ability to manage multiple concurrent studies while maintaining high quality, accuracy, and regulatory compliance
Preferred
D.A.B.T. certification strongly preferred (or active pursuit/eligibility)
Company
BioLegacy Research
BioLegacy Research (formerly BTS Research) provides comprehensive preclinical research services, including GLP and non-GLP toxicology, pharmacokinetics, and specialized NHP and large-animal studies.
11-50 employees
Funding
Current Stage
Early StageRecent News
2025-02-17
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