Nonclinical Toxicology Study Monitoring Scientist

Responsibilities

• Partner with project toxicologists to develop, review, and operationalize protocols for nonclinical safety assessment studies (small and large molecule).
• Serve as primary monitoring contact for outsourced nonclinical studies at CROs/partners.
• Conduct on-site and remote monitoring to assess study conduct, data quality, protocol compliance, and GLP adherence.
• Identify/escalate issues and support resolution with CRO and internal teams.
• Prepare timely monitoring reports, visit summaries, and stakeholder communications.
• Track action items, decisions, and milestones; manage multiple concurrent studies/deliverables.
• Review monitoring reports/documentation and CRO performance metrics; support continuous improvement.
• Support CRO qualification (vendor assessment/audit support) and collaborate on quality review of regulatory documents.
• Apply digital/AI solutions to improve study planning, oversight, risk identification, communication, and knowledge/data sharing.

• Hands-on in vivo lab experience (CRO or pharma/biotech).
• Experience supporting nonclinical safety assessment for both small and large molecule modalities.
• Working knowledge of GLP; strong organizational, multitasking, scientific/problem-solving, and communication skills.
• Ability to thrive in a fast-paced, matrixed environment; attention to detail.

Travel 30%–50% for on-site monitoring/vendor interactions.

• Sponsor-facing study monitoring experience; direct CRO oversight/troubleshooting.
• Regulatory documentation familiarity; vendor qualification/audit support experience.

• Master’s (or equivalent) with 3+ years relevant experience, or Bachelor’s (or equivalent) with 4+ years relevant experience.

• Annual bonus and annual equity awards; medical/dental/vision, paid time off, education assistance (incl. student loan repayment), commuting subsidy, matching charitable donations, 401(k).

$101,600–$152,400.