Principal Scientist, Toxicologist​/Study Director

Job Description Principal Scientist, Toxicologist/Study Director

The Nonclinical Drug Safety department is seeking a motivated and talented toxicologist with immunology and/or biologics experience to conduct and/or monitor toxicity studies (GLP and non‑GLP) as a Study Director or Study Monitor and serve as a departmental representative on drug development teams. Toxicologists at our Company are integral members and leaders of collaborative cross‑functional scientific teams, addressing challenges from early discovery to late development.

Our toxicologists provide scientific leadership in the design and overall conduct of in vivo studies and integrate the findings from all contributing scientists into reports that characterize the safety profile of drug candidates.

Serve as the single point of control (Study Director) on assigned acute through chronic general toxicology studies across all modalities. Interact with technical, veterinary, and scientific staff to ensure that the study is in compliance with the protocol, amendments, Standard Operating Procedures, regulations, safety guidelines, and company policies and procedures. Critically analyze and interpret data. Integrate data from other areas (e.g., clinical pathology, pathology, toxicokinetics) in written reports used for regulatory submissions, and communicate results within established timelines.

Ensure regulatory rigor, proactive risk identification, and timely study execution. Participate on cross‑functional group teams to investigate mechanisms of toxicity, utilizing additional tools and applications that are available on site. Serve as a departmental representative on a product development team, overseeing the strategy and design of nonclinical safety studies and generation of regulatory strategies and communications with global regulatory agencies to support the development of drug candidates.

Demonstrate enterprise mindset and strategic thinking, proactively identifying opportunities, anticipating challenges, and contributing to solutions aligned with broader organizational priorities. Build strong collaborative relationships and influences without authority, contributing to an inclusive team environment and actively learning to coach, develop, and elevate others. Deliver high‑quality results with accountability and agility, translating objectives into action while continuously improving, embracing change, and showing potential to lead larger initiatives over time.

Ph.D. and/or DVM with graduate and/or post‑graduate work training in toxicology, pharmacology, or related scientific discipline.

Minimum of 8 years of relevant experience as a Toxicologist or Study Director in pharma, biotech, or a CRO. Demonstrated understanding of and experience with Good Laboratory Practices (US FDA 21 CFR Part 58). Strong interest in collaborating with diverse cross‑functional teams and communicating openly and often with colleagues. Strong listening, collaboration, and leadership skills. Ability to communicate clearly using verbal and written formats, including presentations and meetings.

Expertise in immunology and/or biologics, especially regulatory requirements and testing.

Knowledgeable about drug development strategies for biotherapeutics and large molecules. Familiarity with outsourced study monitoring. Experience serving as toxicology expert on a drug discovery and development team. Representation of nonclinical safety in regulatory agency interactions.

• Clinical Immunology
• Clinical Pathology
• Cross‑Functional Teamwork
• Detail‑Oriented
• Environmental Toxicology
• Experimentation
• GLP Regulations
• Good Laboratory Practices (GLPs)
• Identifying Risks
• Immunoassays
• Immunology
• Immunotherapy
• Mentoring Staff
• Preclinical Toxicology
• Professional Integrity
• Professional Networking
• Regulatory Requirements
• Report Preparation
• Study Directing
• Study Monitoring
• Technical Advising
• Toxicity Studies
• Toxicology
• Toxicology Research

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