Toxicology Study Manager: GLP/Non-GLP CRO Lead

Regulatory Jobs; Redwood City (CA); On-site; USD 143,000 - 178,000; Full time

Job summary

Revolution Medicines is seeking a Preclinical Study Manager to oversee non-GLP and GLP toxicology studies from research through clinical development. You will be the primary operational liaison with CROs, ensuring study objectives align with scientific and regulatory goals while maintaining compliance with ICH and FDA guidelines.

Responsibilities include coordinating cross-functional teams, reviewing protocols and reports, and supporting regulatory submissions.

Qualifications

• Work with CROs and internal experts to design protocols for scientific objectives.
• Monitor non-GLP and GLP toxicology studies to meet project goals.
• Review protocols, study reports, and amendments to ensure high-quality CRO results.
• Coordinate activities between RevMed personnel and CROs to meet program needs.
• Assist data analysis and generate results tables/graphs as needed.
• Participate in regulatory submissions (nonclinical sections of IBs, NDAs, etc.).
• Maintain relationships with study directors and external collaborators.
• Facilitate CRO vendor selection/audit and due diligence with QA.
• Negotiate contracts and manage internal approvals & execution processes.
• Support SOP/policy development and other duties as needed.

Responsibilities

• Lead CRO coordination to ensure timelines and study objectives are met.
• Review and approve study protocols and reports for accuracy and compliance.
• Collaborate cross-functionally to align study plans with regulatory expectations.
• Support data analysis, tables, and visualization of study outcomes.
• Contribute to regulatory submissions and typifies nonclinical sections.

Skills

CRO management

Toxicology coordination

Regulatory submissions

Data analysis

Project management

ICH/FDA guidelines

Communication

Travel readiness

Education

BS degree in science

Tools

SOP development

Job description

Revolution Medicines is seeking a Preclinical Study Manager to oversee non-GLP and GLP toxicology studies from research through clinical development. You will be the primary operational liaison with CROs, ensuring study objectives align with scientific and regulatory goals while maintaining compliance with ICH and FDA guidelines.

Responsibilities include coordinating cross-functional teams, reviewing protocols and reports, and supporting regulatory submissions.