Director, Safety Assessment

Altasciences seeks a Director to lead the Safety Assessment department, overseeing GLP compliance, strategic planning, and preclinical safety programs. The role includes managing staff, supporting business development, and serving as FDA regulatory liaison for a contract research organization.

Responsibilities

• Lead GLP compliance initiatives and develop strategic departmental policies and procedures
• Manage Study Directors, approve protocols, and ensure scientific review of study reports
• Participate in client meetings to support business development and regulatory communications
• Direct departmental resources, budgets, and personnel assignments to ensure operational efficiency
• Mentor staff on drug development requirements, client management, and regulatory compliance

Requirements

• Ph.D. in biomedical field, MD, DVM, or Master's degree with relevant training
• Minimum 7 years evaluating pharmaceutical preclinical safety and toxicology studies
• Previous management or supervision 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
• Advanced proficiency in scientific communication, statistical analysis, and GLP regulations
• DABT certification desirable; demonstrated leadership and strategic problem-solving ability

Compensation: $126,000 - $200,000