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