Job Description

AbbVie seeks a Senior Scientist in Toxicology to serve as GLP Study Director for internally conducted toxicology studies and external sponsor monitor for contract research organization studies. The role involves designing, conducting, and reporting toxicology studies while ensuring regulatory compliance and quality standards for pharmaceutical development.

Responsibilities

• Function as GLP Study Director for approximately 80% of toxicology studies conducted internally
• Serve as sponsor monitor for toxicology studies conducted at contract research organizations
• Author and review GLP toxicology study reports and prepare regulatory filing documents for global submissions
• Design and conduct toxicology studies aligned with development plans and regulatory expectations
• Communicate scientific findings and represent sponsor compliance across audits, project teams, and committees

Requirements

• Bachelor's degree with 10 years toxicology experience, or Master's degree with 8 years experience, or PhD in Toxicology or related field
• Up to 4 years study director experience in pharmaceutical or contract research organization setting preferred
• Strong understanding of FDA, ICH, and OECD regulations and guidelines
• Expertise in GLP and non-GLP study conduct with demonstrated scientific agility and accountability
• Excellent written and verbal communication skills for regulatory materials and presentations
• Ability to design, evaluate, and interpret toxicology experiments and resolve study conduct issues

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