Study Director / Technical Assistant - Non-clinical Toxicity studies

Job Description 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