Senior Toxicology Lead: CRO Oversight & IND Support

Treeline; San Diego (CA); On-site; USD 207,000 - 243,000; Full time

Job summary

Treeline is seeking an Associate Director/Director of Toxicology to lead nonclinical study oversight and safeguard data quality across discovery and development programs. The role interfaces with CROs, plans and monitors studies, and guides regulatory-ready submissions.

The ideal candidate brings strong scientific judgment, regulatory familiarity, and hands-on management of GLP and non-GLP toxicology studies, aligning timelines and budgets with program goals.

Qualifications

• Advanced degree in toxicology or related biomedical science required.
• 5–10 years of toxicology experience in pharma/biotech/CRO settings.
• Experience writing/reviewing toxicology study plans/protocols and final reports.
• Experience interfacing with CROs on in-life toxicology studies.
• Familiarity with GMP regulations and ICH guidelines (M3(R2), S9, S6).
• DABT certification strongly recommended.

Responsibilities

• Author, review, and finalize study protocols, amendments, and reports with CRO partners.
• Interface with CROs to scope, monitor, and troubleshoot in-life toxicology studies (GMP and non-GLP).
• Serve as Study Monitor for in-life toxicology studies with on-site or virtual visits.
• Own budget tracking and oversight for assigned studies, reviewing quotes and change orders.
• Review and interpret toxicology data to assess safety signals and inform dose selection.
• Contribute toxicology sections for IND/CTA submissions and health authority responses.
• Collaborate with DMPK, pharmacology, CMC, and clinical teams to integrate findings into program risk assessments.
• Track study timelines and budgets across multiple CRO studies; escalate risks as needed.
• Stay current with FDA/ICH/EMA guidance and industry best practices.
• Serve as toxicology expert on multidisciplinary teams from discovery through IND/CTA and beyond.

Skills

Scientific writing

Study oversight

CRO management

Regulatory awareness

Education

Advanced degree in Toxicology or related field

Tools

Veeva

Job description

Treeline is seeking an Associate Director/Director of Toxicology to lead nonclinical study oversight and safeguard data quality across discovery and development programs. The role interfaces with CROs, plans and monitors studies, and guides regulatory-ready submissions.

The ideal candidate brings strong scientific judgment, regulatory familiarity, and hands-on management of GLP and non-GLP toxicology studies, aligning timelines and budgets with program goals.