Senior Toxicology Study Director (GLP)

Actox; Chicago (IL); Hybrid; USD 180,000 - 240,000; Full time

Job summary

AbbVie seeks a GLP Study Director to oversee internally conducted toxicology studies (80%) and monitor external CRO work (<20%). You will ensure quality and regulatory compliance in study conduct, and lead GLP report authorship and filings for global submissions. The role requires serving as a scientific expert during audits and project teams.

The position involves designing and conducting toxicology studies, applying regulatory information to development plans, and communicating key findings. Depending on experience, level may be Sr Sci I or Sr Sci II, with strong writing and regulatory skills.

Qualifications

• Bachelor’s degree or higher with relevant experience.
• PhD in Toxicology or related field preferred.
• Experience with GLP and non-GLP study conduct.
• Strong written and verbal communication skills.
• Ability to resolve study design and regulatory issues using available information.

Responsibilities

• Function as GLP Study Director for toxicology studies (80% internal, <20% external).
• Ensure high standards of quality and regulatory compliance in study conduct and reporting.
• Authorship of GLP reports and preparation of filing documents for global submissions.
• Serve as scientific expert for audits, project teams, and regulatory discussions.
• Design, conduct and report toxicology studies aligned with development plans and regulatory expectations.

Skills

Toxicology expertise

Excellent communication

Regulatory knowledge

Auditing experience

Report writing

Education

Bachelor's degree

Master's degree

PhD in Toxicology

Job description

AbbVie seeks a GLP Study Director to oversee internally conducted toxicology studies (80%) and monitor external CRO work (<20%). You will ensure quality and regulatory compliance in study conduct, and lead GLP report authorship and filings for global submissions. The role requires serving as a scientific expert during audits and project teams.

The position involves designing and conducting toxicology studies, applying regulatory information to development plans, and communicating key findings. Depending on experience, level may be Sr Sci I or Sr Sci II, with strong writing and regulatory skills.