Principal Scientist, Preclinical Toxicology

Principal Scientist, Preclinical Toxicology Join us to apply for the Principal Scientist, Preclinical Toxicology role at BioLegacy Research. 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 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 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 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 BioLegacy’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 BioLegacy 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 Relations: Excellent communication and interpersonal skills, with the ability to foster client confidence and deliver clear scientific guidance. Project Execution: Strong organizational and problem‑solving skills, capable of ensuring quality and efficiency across multiple concurrent studies. 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 for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Additional Information Seniority level Mid‑Senior level Employment type Full‑time Job function Research, Analyst, and Information Technology #J-18808-Ljbffr