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

Responsibilities

• 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

Requirements

• 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
• Full accountability and ownership of study deliverables
• Excellent time management and ability to meet strict deadlines
• Strong knowledge of regulatory frameworks and compliance requirements

Preferred

• Leadership capability with mentoring potential