Associate Director / Director, Nonclinical Toxicology
About The Position
Treeline Biosciences is seeking an experienced Associate Director or Director of Toxicology to join its nonclinical development team. The role supports discovery and development programs, primarily through nonclinical study oversight and toxicology, and serves as a key scientific and operational interface with external contract research organizations (CROs). The position is responsible for planning, executing, and monitoring nonclinical studies while ensuring scientific rigor, data quality, regulatory alignment, and adherence to program timelines. It also contributes to nonclinical regulatory dossier documentation. The role provides scientific and strategic partnership to cross-functional project teams and drives the design, execution, and interpretation of nonclinical toxicology studies for IND-enabling and lifecycle safety assessment programs. It collaborates with internal project leaders, DMPK, regulatory affairs, and clinical development stakeholders, while overseeing external CROs conducting GLP and non-GLP toxicology studies. This is a hands-on, operationally focused position requiring scientific judgment and management of multiple CRO-run studies to keep them on schedule, on budget, and audit-ready. The level of hire—Associate Director or Director—will depend on the candidate’s experience, scope of responsibility, and demonstrated leadership.
Requirements
- S., M.S., Ph.D., DVM, or an advanced degree in Toxicology, Pharmacology, Veterinary Medicine, or a related biomedical science, or equivalent experience.
- 5–10 years of relevant toxicology experience in pharmaceutical, biotech, or CRO settings.
- Demonstrated experience writing and reviewing toxicology study plans or protocols and final study reports.
- Direct experience managing or interfacing with CROs conducting in-life toxicology studies.
- Experience serving as Study Monitor on GMP toxicology studies, including in-life visits, protocol and report review, and direct communication with CRO study directors.
- Working knowledge of study budgets, including reviewing CRO quotes and change orders, tracking spend against budget, and identifying scope or cost deviations.
- Solid understanding of GMP regulations, ICH guidelines (e.g., M3(R2), S9, S6), and FDA/EMA nonclinical safety expectations.
- Demonstrated experience contributing toxicology content to IND submissions or CTA equivalents, including authoring nonclinical written summaries and supporting health authority interactions.
- Strong written and verbal communication skills, including the ability to explain complex scientific concepts to cross-functional and non-toxicology audiences.
- Ability to manage multiple projects and timelines in a fast-paced, deadline-driven environment.
Nice To Haves
- DABT (Diplomate, American Board of Toxicology) certification is strongly recommended.
- Experience across multiple modalities, such as small molecules, biologics, and ADCs.
- Prior sponsor-side experience managing external vendor relationships.
- Experience presenting toxicology data to internal governance committees or health authorities.
- Experience with Veeva or other document management systems.
Responsibilities
- Author, review, and finalize toxicology study protocols, amendments, and study reports with CRO partners, ensuring scientific rigor and regulatory compliance.
- Interface with CROs to scope, place, monitor, and troubleshoot in-life toxicology studies, 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 follow-up with CRO study directors.
- Track and oversee budgets for assigned studies by reviewing CRO quotes and change orders, monitoring spend against forecasts, and flagging deviations to project teams and finance.
- Review and interpret toxicology data, including clinical pathology, histopathology, and 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, and support responses to health authority questions.
- Partner with DMPK, pharmacology, CMC, and clinical teams to integrate toxicology findings into program risk/benefit assessments.
- Track study timelines, budgets, and deliverables across concurrent CRO-run studies; proactively escalate risks and resolve issues.
- Stay current with FDA, ICH, and EMA regulatory guidance and industry best practices in toxicology and nonclinical safety assessment.
- Represent toxicology and provide strategic scientific input on nonclinical safety strategy to multidisciplinary project teams from discovery through IND/CTA filing and beyond.
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What This Job Offers
Job Type
Full-time
Career Level
Director
