Overview In this role you oversee outsourced nonclinical safety studies across small and large molecule modalities, ensuring scientific rigor and timely execution. You partner with toxicology leads and cross-functional teams to operationalize study protocols and monitor CRO performance. You will communicate key findings and risks to stakeholders, driving action and improvements. This position offers the chance to contribute to safety assessments in a fast-paced, matrixed environment and to explore digital/AI-enabled approaches to study oversight. You will help shape how we modernize nonclinical study monitoring to support development decisions.
Compensation / Benefits- medical, dental and vision benefits
- generous paid time off including a week-long company shutdown
- educational assistance including student loan repayment
- commuting subsidy
- 401(k) and matching charitable donations
- equity awards
Responsibilities- Collaborate with project toxicologists and stakeholders to develop and implement nonclinical safety study protocols
- Act as primary monitoring contact for outsourced toxicology studies at CROs and partner organizations
- Conduct on-site and remote monitoring to assess conduct, data quality, and GLP compliance
- Identify and escalate scientific, operational, or study execution issues with CROs and internal teams
- Prepare clear monitoring reports, visit summaries, and stakeholder updates on status and risks
- Drive follow-up on action items and milestones across multiple studies
- Manage multiple concurrent studies, timelines, and deliverables with attention to quality and detail
- Contribute to review of monitoring reports and CRO performance metrics for continuous improvement
- Support CRO qualification activities, including vendor assessment and audit input
- Collaborate to support regulatory document reviews and health authority responses
- Apply digital and AI-based solutions to enhance planning, oversight, and data sharing
Key requirements- Hands-on in vivo laboratory experience in CRO or biotech/pharma setting
- Direct experience supporting nonclinical safety for small and large molecules
- Foundational understanding of drug discovery and nonclinical safety development
- Working knowledge of GLP and sponsor oversight requirements
- Strong organizational and multitasking abilities across multiple studies
- Robust scientific problem-solving and risk assessment skills
- Excellent written and verbal communication for diverse audiences
- Ability to thrive in a fast-paced, matrixed environment with adaptable priorities
- Comfort with adopting digital tools and AI-enabled solutions for workflow improvements
- collaboration
- clear communication
- problem-solving
- GLP compliance
- nonclinical safety assessment
- study monitoring and CRO oversight
