Toxicology Study Director, II

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

This position is in the Toxicology line function within the Preclinical Safety group and will report to the Director, Associate Director or a Sr. Group leader in Toxicology. This role designs, conducts and reports non-GLP and GLP general toxicology studies in support of drug submissions to regulatory agencies, and requires demonstrated effective written and communication skills.

CORE JOB RESPONSIBILITIES:
The primary responsibility of this job is to function as GLP Study Director for AbbVie internally conducted toxicology studies (80% of time) and external sponsor monitor for studies conducted at contract research organizations (< 20% of time).

As study director, the incumbent ensures the highest standards in quality and regulatory compliance are met in study conduct and reporting.

Accountable for all aspects of Good Laboratory Practice (GLP) report authorship, including writing and reviewing toxicology study reports and preparing assigned components of filing documents that support submissions to global regulatory agencies for drugs in development.
Serve as scientific expert for studies, during audits and on project teams, committees and other assignments. Accurately identify key scientific findings and effectively communicate findings in reports, presentations, and meetings.

Manages study timelines against regulatory filing needs and in coordination with line function management.
Demonstrate the ability to resolve key planning and study conduct issues by effectively utilizing available information and technical expertise.

POSITION ACCOUNTABILITY / SCOPE:

Responsible for representing Sponsor in all aspects of GLP compliance within assigned studies and related