Overview In this role you lead outsourced nonclinical safety studies from planning to final reporting, applying toxicology and regulatory judgment to ensure high-quality, inspection-ready outputs. You'll manage CRO partnerships and cross-functional alignment to support discovery and regulatory development programs. You'll drive study timelines, risk mitigation, and continuous improvement in study monitoring and reporting practices. This position offers meaningful impact by advancing safe, effective therapies through meticulous nonclinical work.
Compensation / Benefits- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
- comprehensive benefits package (medical, dental, vision, life)
Responsibilities- Monitor and coordinate outsourced nonclinical safety studies for discovery and regulatory programs, including planning, testing coordination, logistics, protocol development, dose selection, CRO communication, on-site monitoring, data and report review, and archival
- Lead multi-study projects with clear timelines, critical path activities, and issue resolution for formulation or test material challenges
- Coordinate and lead internal and external study meetings across CROs, toxicologists, analytical and regulatory partners to ensure timely execution
- Review protocols, amendments, raw data summaries, and reports for scientific accuracy and regulatory alignment
- Prepare study result slides, tabulated summaries, and sections for regulatory documents (INDs, NDAs, BLAs, IDEs)
- Perform independent QC of study protocols, reports, SEND outputs, and regulatory submissions to ensure inspection-ready deliverables
- Apply GLP nonclinical study expertise to identify risks and ensure timely study completion
- Support CRO site qualification, vendor oversight, and issue escalation as needed
- Contribute to SOP reviews, process improvements, template harmonization, and mentoring of less experienced colleagues
- Serve as technical expert on nonclinical study designs, logistics, CRO interactions, and monitoring best practices
- Conduct literature searches to inform study planning and regulatory support activities
- Travel for CRO monitoring or qualification activities, typically
Key requirements- Bachelor's Degree with 6+ years of experience or Master's Degree with 4+ years of experience in a relevant field
- Direct experience monitoring GLP-regulated nonclinical safety studies across multiple study types and species
- Strong understanding of toxicology principles, biology, physiology, study design, dose selection, toxicokinetics, and pathology workflows
- Working knowledge of GLP regulations and regulatory guidance (FDA, ICH, EMA, OECD)
- Knowledge of laboratory animal welfare standards (USDA, AAALAC) and IACUC processes
- Proven ability to manage CRO relationships, coordinate concurrent studies, and meet timelines under tight deadlines
- Excellent written and verbal communication for diverse stakeholders
- Strong organizational skills, attention to detail, analytical thinking, and independent work
- Proficiency with Microsoft Word, PowerPoint, Excel; familiarity with study tracking and SEND tools (preferred)
- Membership or active participation in professional organizations such as ACT or SOT (encouraged)
- Effective communication
- Proactivity and problem solving
- Cross-functional collaboration
- GLP-regulated nonclinical safety
- Toxicology and nonclinical development knowledge
- CRO/vendor management
