Principal Scientist, Preclinical Toxicology

Principal Scientist, Preclinical Toxicology

Join us to apply for the Principal Scientist, Preclinical Toxicology role at Bio Legacy Research.

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 leading 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 combines deep toxicology expertise with strategic insight and the ability to coordinate complex study activities across multiple disciplines.

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. Working closely with internal scientific teams, you will ensure operational alignment, data quality, and regulatory compliance—supporting successful regulatory submissions such as IND, NDA, and BLA to agencies including the FDA.

Key Responsibilities

• Serve as the principal scientific contact for clients, building long‑term partnerships grounded in trust and technical excellence.

• Collaborate with clients to understand program objectives and develop scientifically rigorous, customized toxicology study designs that meet regulatory and development needs.

• Provide scientific direction to internal study teams to ensure alignment of design, execution, and data interpretation.

Study Oversight and Execution

• Author, review, and finalize study protocols and amendments consistent with client goals and GLP standards.

• Function as the Study Director or Principal Investigator for GLP studies, assuming responsibility for scientific conduct, data integrity, and final reporting.

• Monitor study performance and cross‑functional coordination across in‑vivo and in‑vitro operations to ensure efficiency, consistency, and compliance.

Data Analysis and Reporting

• Integrate and interpret toxicology, pathology, and clinical pathology data to generate meaningful conclusions and regulatory insights.

• Prepare and review high‑quality study reports that accurately reflect study outcomes.

• Communicate study findings and implications clearly to clients through meetings, presentations, and written reports.

Regulatory and Quality Assurance

• Ensure all studies are performed in full compliance with FDA GLP regulations and applicable international guidelines (e.g., ICH).

• Support clients in preparing nonclinical sections for regulatory submissions (IND, NDA, BLA).

• Represent Bio Legacy Research and provide scientific support during audits and health authority inspections.

Qualifications and Experience

• Ph.D. in Toxicology, Pharmacology, or a related scientific discipline.

• Minimum of 5–7 years of experience designing, managing, and interpreting GLP toxicology studies, preferably within a CRO or similar environment.

• Demonstrated experience serving as Study Director for GLP‑compliant studies.

• D.A.B.T. (Diplomate of the American Board of Toxicology) certification or eligibility strongly preferred.

Technical Knowledge and Skills

• GLP Expertise:
Comprehensive understanding of GLP regulations, study design, and conduct across all stages of nonclinical toxicology.

• Scientific Leadership:
Proven ability to guide complex study programs and ensure cross‑functional alignment across in‑vivo and in‑vitro operations.

• Client…