Study Director Technical Assistant - Non-clinical Toxicity Studies

2.0 KEY RESPONSIBILITIES

2.1 Study Leadership and Regulatory Compliance

• Serve as Study Director, Principal Investigator, or Technical Assistant for non-clinical toxicity studies
• Ensure full compliance with GLP, OECD, ICH, FDA, and EPA guidelines, as well as sponsor-specific requirements
• Lead all aspects of study execution, including planning, conduct, oversight, data interpretation, and comprehensive reporting
• Demonstrate expertise in GLP-compliant non-clinical toxicity study design and execution
• Administer test items via multiple routes of exposure with proficiency and precision

2.2 Data Management and Scientific Reporting

• Conduct thorough review of study data to identify deviations and inconsistencies
• Evaluate study results objectively and prepare high-quality study reports, amendments, and responses to sponsor inquiries
• Ensure timely and accurate submission of all scientific documentation

2.3 Cross-Functional Coordination and Stakeholder Management

• Coordinate effectively with sponsors, pathology, analytical, bioanalytical, veterinary, and quality assurance teams
• Maintain adherence to study timelines and deliverables
• Participate in sponsor meetings and provide regular study updates
• Support regulatory submission activities

2.4 Core Competencies

• Scientific and analytical thinking with strong problem-solving capabilities
• Meticulous attention to detail with commitment to quality excellence
• Sound decision-making and critical thinking skills
• Clear and professional communication with sponsors and cross-functional teams
• Leadership capability with mentoring potential
• Full accountability and ownership of study deliverables
• Excellent time management and ability to meet strict deadlines
• Strong knowledge of regulatory frameworks and compliance requirements