About the Role
We are seeking an experienced Associate Director or Director of Toxicology to join our nonclinical development team to support discovery and development programs, with a primary focus on nonclinical study oversight and toxicology. The primary focus of this role is to act as a key scientific and operational interface with external contract research organizations (CROs). The individual in this role will assume primary responsibility for the planning, execution, and monitoring of nonclinical studies, ensuring scientific rigor, data quality, and alignment with program timelines and regulatory expectations. This position requires strong scientific judgment, knowledge of regulatory guidance, effective communication, and the ability to independently manage multiple studies in a fast-paced, mission-driven environment. This role will also contribute to the preparation of nonclinical components of regulatory dossiers related documentation.
This individual will also serve as a scientific and strategic partner to cross-functional project teams, driving the design, execution, and interpretation of nonclinical toxicology studies in support of IND-enabling and lifecycle safety assessment programs. The role requires close collaboration with internal stakeholders (project leaders, DMPK, regulatory affairs, clinical development) as well as direct oversight of external Contract Research Organizations (CROs) conducting GLP and non-GLP toxicology studies.
This is a hands-on, operationally-focused role: the ideal candidate pairs strong scientific judgment with the rigor to keep multiple CRO-run studies on schedule, on budget, and audit-ready.
The level of hire (Associate Director vs. Director) will be determined based on the candidate's experience, scope of responsibility, and demonstrated leadership.
Key Responsibilities
Author, review, and finalize toxicology study protocols, amendments, and study reports in collaboration with CRO partners, ensuring scientific rigor and regulatory compliance.
Interface directly with CROs to scope, place, monitor, and troubleshoot in-life toxicology studies (GMP and non-GMP), including dose range-finding, repeat-dose, safety pharmacology, and specialized studies as needed.
Serve as Study Monitor for in-life toxicology studies, including on-site or virtual monitoring visits, real-time issue resolution, and direct follow-up with CRO study directors to keep studies on track.
Own budget tracking and oversight for assigned studies — reviewing CRO quotes and change orders, monitoring spend against forecast, and flagging deviations to project teams and finance.
Review and interpret toxicology data (clinical pathology, histopathology, TK/PK) to assess safety signals and inform risk assessment and dose selection.
Author and contribute toxicology sections for IND (or CTA) submissions, Investigator's Brochures, and briefing documents; support preparation of responses to health authority questions.
Partner with DMPK, pharmacology, CMC, and clinical teams to integrate toxicology findings into overall program risk/benefit assessments.
Track study timelines, budgets, and deliverables across multiple concurrent CRO-run studies; escalate risks and resolve issues proactively.
Stay current with regulatory guidance (FDA, ICH, EMA) and industry best practices in toxicology and nonclinical safety assessment.
Serve as toxicology representative and strategic partner on multidisciplinary project teams, providing scientific input on nonclinical safety strategy from discovery through IND/CTA filing and beyond.
Required Qualifications
S., M.S., Ph.D., DVM, or advanced degree in Toxicology, Pharmacology, Veterinary Medicine, or a related biomedical science (or equivalent experience).
5–10 years of relevant experience in toxicology within pharmaceutical, biotech, or CRO settings.
Demonstrated experience writing and reviewing toxicology study plans/protocols and final study reports.
Direct experience managing or interfacing with…