Nonclinical Toxicology Study Monitoring Scientist

Job Description General Summary: We are seeking a Nonclinical Toxicology Study Monitoring Scientist to play a critical role in supporting the safety assessment of both large and small molecule modalities including cell and gene therapies across the development pipeline by providing scientific, technical, and operational oversight of outsourced nonclinical studies. This individual will partner closely with project toxicologists, cross-functional internal teams, and external Contract Research Organizations (CROs) to help ensure studies are executed to high scientific and operational standards, in alignment with study objectives, timelines, and regulatory expectations. This role is best suited for a scientifically grounded, highly organized, collaborative study monitor who thrives in a fast-paced environment, excels at managing multiple studies and competing priorities simultaneously, and communicates clearly and succinctly to drive study execution and decision-making. This role is a scientific and operational study monitoring position, not a Quality Assurance role. While partnership with QA and attention to compliance are important, the primary focus is on study monitoring, scientific oversight, CRO partnership, issue resolution, organization, and cross-functional communication in support of nonclinical program execution. This role is central to ensuring that nonclinical safety studies are conducted with scientific rigor, operational excellence, and effective external oversight. The Nonclinical Toxicology Study Monitoring Scientist helps generate the high-quality data needed to inform development decisions and advance promising therapies for patients, while also helping the organization modernize study oversight through thoughtful adoption of digital and AI-enabled ways of working. Key Duties and Responsibilities: · Partner with project toxicologists and cross-functional stakeholders to develop, review, and operationalize protocols for nonclinical safety assessment studies across both small and large molecule programs. · Serve as a primary monitoring contact for outsourced toxicology and other nonclinical safety studies conducted at CROs and partner organizations. · Conduct routine study monitoring activities through on-site visits and remote oversight to assess study conduct, data quality, protocol compliance, and adherence to GLP and applicable procedures. · Identify, escalate, and help resolve scientific, technical, operational, or study execution issues arising during study conduct in collaboration with CRO personnel, internal toxicologists, and study monitoring colleagues. · Prepare clear, concise, and timely study monitoring reports, visit summaries, and stakeholder communications to ensure visibility to study status, key findings, risks, and next steps. · Drive strong follow-up and documentation of action items, decisions, and study milestones across multiple active studies. · Effectively manage multiple concurrent studies, deliverables, timelines, and follow-up activities in a fast-paced environment while maintaining high quality, attention to detail, and responsiveness. · Contribute to the review of monitoring reports, study documentation, and CRO performance metrics to support continuous improvement in vendor oversight and study execution. · Support qualification activities for CROs, including vendor assessment, audit support, and input into the selection of new external partners. · Collaborate with other study monitor scientists and project toxicologists to support quality review of regulatory documents, submissions, and health authority responses, as applicable. · Demonstrated ability and strong interest in applying digital and AI-based solutions to enhance study planning, study oversight, risk identification, communication, and the sharing of data and knowledge. · Willingness and ability to travel 30%–50% for on-site study monitoring visits and vendor interactions. Knowledge and Skills: Hands-on in vivo laboratory experience in a CRO or pharmaceutical/biotechnology setting. Direct experience supporting nonclinical safety assessment activities involving both small molecule and large molecule modalities. Foundational understanding of the drug discovery and development process, particularly as it relates to nonclinical safety assessment. Working knowledge of Good Laboratory Practice (GLP) regulations and expectations for study conduct and sponsor oversight. Superior organizational and multitasking skills, with the ability to manage multiple concurrent studies, timelines, deliverables, and follow-up activities without losing attention to detail. Strong scientific and problem-solving skills, with the ability to identify issues, assess risk, and support effective resolution during study execution. Excellent interpersonal skills with a demonstrated ability to build productive working relationships with CRO partners, vendors, and internal stakeholders. Excellent written and verbal communication skills, including the ability to communicate complex study information clearly, succinctly, and appropriately for different audiences. Demonstrated ability to thrive in a fast-paced, matrixed environment, successfully adapting to changing priorities while maintaining high-quality execution and clear communication. Strong attention to detail and commitment to high-quality study oversight, documentation, and execution. Comfort adopting new digital tools and technologies, including the exploration and build-out of AI-enabled solutions, to streamline workflows, improve tracking, and support efficient study oversight. Prior experience monitoring outsourced toxicology or nonclinical safety studies in a sponsor-facing study monitoring role. Experience working directly with CROs to oversee study execution, troubleshoot issues, and drive accountability to timelines and deliverables. Demonstrated success in highly organized, detail-oriented roles requiring coordination of