Study Director Technical Assistant - Non-clinical Toxicity Studies

Eurofins Viracor; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Eurofins Viracor Bengaluru is seeking a senior professional to lead non-clinical toxicity studies under GLP guidelines. The role requires directing study planning, execution, data interpretation, and reporting with sponsor interaction.

You will ensure compliance with GLP, OECD, ICH, FDA, and EPA guidelines, manage cross-functional teams, and mentor staff to deliver timely, high-quality study deliverables within strict deadlines.

Qualifications

• Experience as Study Director or Principal Investigator for non-clinical toxicity studies.
• Strong knowledge of GLP, OECD, ICH, FDA and EPA guidelines.
• Ability to lead study execution from planning to reporting and data interpretation.
• Demonstrated ability to coordinate cross-functional teams and stakeholders.
• Proven track record of meeting strict timelines and quality standards.

Responsibilities

• Serve as Study Director, PI, or Technical Assistant for non-clinical toxicity studies.
• Ensure GLP and regulatory compliance for all study activities.
• Lead planning, conduct, oversight, data interpretation, and reporting of studies.
• Coordinate with sponsors and QA, pathology, analytical, and other teams.
• Maintain study timelines, deliverables, and sponsor communications.
• Mentor team members and uphold ownership of study deliverables.

Skills

Scientific thinking

Attention to detail

Decision making

Communication

Leadership

Accountability

Time management

Regulatory knowledge

Job description

Job Description:

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

Requirements: