Job Description

Vertex Pharmaceuticals seeks a Nonclinical Toxicology Study Monitoring Scientist to oversee outsourced safety studies for drug candidates across development stages. The role combines scientific oversight, CRO partnership, and operational management to ensure studies meet regulatory standards and generate high-quality safety data.

Responsibilities

• Develop, review, and operationalize nonclinical safety protocols with project toxicologists and cross-functional teams
• Serve as primary monitoring contact for outsourced toxicology studies at CROs and partner organizations
• Conduct on-site and remote monitoring to assess study conduct, data quality, protocol compliance, and GLP adherence
• Identify, escalate, and resolve scientific, technical, and operational issues in collaboration with CRO and internal stakeholders
• Prepare monitoring reports, visit summaries, and stakeholder communications tracking study status, findings, and risks

Requirements

• Hands-on in vivo laboratory experience in CRO or pharmaceutical/biotechnology setting
• Direct experience supporting nonclinical safety assessment for small and large molecule modalities
• Working knowledge of Good Laboratory Practice regulations and sponsor oversight expectations
• Superior organizational skills managing multiple concurrent studies with attention to detail
• Strong scientific problem-solving abilities and risk assessment capabilities
• Excellent written and verbal communication skills for diverse audiences
• Prior experience in sponsor-facing study monitoring role overseeing outsourced toxicology studies

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