Job Description

Director leading the Safety Assessment department at a contract research organization, responsible for GLP compliance, strategic planning, regulatory oversight, and management of Study Directors. Role involves directing departmental operations to ensure quality and efficiency while supporting business development.

Responsibilities

• Lead GLP compliance initiatives and oversee development of strategic plans and policies
• Develop, review, and implement SOPs, training materials, and procedural documentation
• Manage Study Directors, approve protocols, and ensure scientific review of study reports
• Participate in client meetings for business development and regulatory agency interactions
• Direct departmental resources, personnel, and budget allocations

Requirements

• Ph.D. in biomedical field, MD, DVM, or Master's degree with relevant training and experience
• Minimum 7 years evaluating pharmaceutical preclinical safety and toxicology studies
• Previous management or supervisory experience with teams or groups
• Minimum 5 years conducting and managing preclinical safety and efficacy programs
• Experience writing and presenting preclinical safety reports for regulatory submissions
• Strong written and verbal communication skills with ability to present scientific findings
• Knowledge of GLP regulations, toxicology guidelines, and preclinical drug development requirements

Compensation: $126,000 - $200,000 base

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