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.
- 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.
Study Oversight and Execution
- 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.
Data Analysis and Reporting
- 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.
Regulatory and Quality Assurance
- 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.
Required Skills & Experience:
- 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.
Preferred Qualifications:
- D.A.B.T. certification strongly preferred (or active pursuit/eligibility).
- Experience preparing or contributing to IND/NDA/BLA nonclinical packages, with familiarity interacting with FDA or supporting sponsor regulatory strategy.
Technical Knowledge and Skills:
- 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.
Compensation & Benefits:
- Competitive Base Salary: Estimated range of $140,000 – $180,000 USD, commensurate with experience.
- Comprehensive Health Benefits: Medical, dental, and vision insurance.
- Paid Time Off: Vacation, sick leave, and paid holidays.
- Professional Development: Opportunities for continued training and career growth.
Equal Opportunity Employer:
BioLegacy is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
