Associate Director / Director, Nonclinical Toxicology

The role

This person will provide nonclinical study oversight and toxicology support for discovery and development programs. They will act as a scientific and operational interface with external contract research organizations.

What you will do

• Author, review, and finalize toxicology study protocols, amendments, and study reports.
• Interface with CROs to scope, place, monitor, and troubleshoot in-life toxicology studies.
• Serve as Study Monitor for in-life toxicology studies via on-site or virtual monitoring visits.
• Own budget tracking and oversight for assigned studies.
• Review and interpret toxicology data to assess safety signals.
• Author and contribute toxicology sections for IND or CTA submissions, Investigator's Brochures, and briefing documents.
• Partner with DMPK, pharmacology, CMC, and clinical teams to integrate toxicology findings.
• Track study timelines, budgets, and deliverables across multiple concurrent CRO-run studies.
• Stay current with regulatory guidance and industry best practices.
• Serve as toxicology representative on multidisciplinary project teams.

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 CROs conducting in-life toxicology studies.
• Experience serving as Study Monitor on GMP toxicology studies.
• Working knowledge of study budgets.
• Solid understanding of GMP regulations, ICH guidelines, and FDA/EMA nonclinical safety expectations.
• Demonstrated experience contributing toxicology content to IND submissions (or CTA equivalent).
• Strong written and verbal communication skills.
• Proven ability to manage multiple projects and timelines in a fast-paced, deadline-driven environment.

Nice to have

• DABT (Diplomate, American Board of Toxicology) certification strongly recommended
• Experience across multiple modalities (small molecule, biologics, ADCs)
• Prior experience in a sponsor-side role managing external vendor relationships
• Experience presenting toxicology data to internal governance committees or health authorities
• Experience with Veeva or other document management systems

About the company

Treeline Biosciences is a multi-state employer.