Nonclinical Toxicology Study Monitoring Scientist

Job Description General Summary

Location:

Boston Fan Pier / Hybrid

Department:
Nonclinical Safety / Toxicology

Travel: 30%–50%

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.

• 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, elevate, 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.

• 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…