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Salary: USD 207,000 - 243,252 / annual
Treeline Biosciences is seeking an experienced Associate Director or Director of Nonclinical Toxicology to join the nonclinical development team. This is a hands-on, operationally-focused role that serves as a key scientific and operational interface with external contract research organizations (CROs).
The successful candidate will assume primary responsibility for planning, execution, and monitoring of nonclinical toxicology studies, ensuring scientific rigor, data quality, and alignment with program timelines and regulatory expectations. The role 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.
Key responsibilities include:
- Authoring, reviewing, and finalizing toxicology study protocols, amendments, and study reports in collaboration with CRO partners
- Interfacing directly with CROs to scope, place, monitor, and troubleshoot in-life toxicology studies (GLP and non-GLP), including dose range-finding, repeat-dose, and safety pharmacology studies
- Serving as Study Monitor for in-life toxicology studies, including on-site or virtual monitoring visits and real-time issue resolution
- Owning budget tracking and oversight for assigned studies, reviewing CRO quotes and change orders, and monitoring spend against forecast
- Reviewing and interpreting toxicology data (clinical pathology, histopathology, TK/PK) to assess safety signals and inform risk assessment
- Authoring and contributing toxicology sections for IND (or CTA) submissions, Investigator's Brochures, and briefing documents
- Partnering with DMPK, pharmacology, CMC, and clinical teams to integrate toxicology findings into overall program risk/benefit assessments
- Tracking study timelines, budgets, and deliverables across multiple concurrent CRO-run studies
- Staying current with regulatory guidance (FDA, ICH, EMA) and industry best practices
- Serving as toxicology representative on multidisciplinary project teams
The level of hire (Associate Director vs. Director) will be determined based on the candidate's experience, scope of responsibility, and demonstrated leadership.
REQUIREMENTS:
- B.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 GLP toxicology studies, including in-life visits, protocol/report review, and direct communication with CRO study directors
- Working knowledge of study budgets — able to review CRO quotes/change orders, track spend against budget, and flag scope or cost deviations
- Solid understanding of GLP 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 equivalent), including authoring nonclinical written summaries and supporting health authority interactions
- Strong written and verbal communication skills, with the ability to clearly convey complex scientific concepts to cross-functional and non-toxicology audiences
- Proven ability to manage multiple projects and timelines in a fast-paced, deadline-driven environment
- DABT (Diplomate, American Board of Toxicology) certification strongly recommended
PREFERRED QUALIFICATIONS:
- 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
