Primary job function:
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 (90 % of time) and external sponsor monitor for studies conducted at contract research organizations (< 10% 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 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.
- Demonstrate the ability to resolve key project study and assumptions by effectively utilizing available information and technical expertise.
- Responsible for all aspects of GLP compliance within assigned studies and related departmental activities. Design, conduct and report toxicology studies appropriate to overall development plans and aligned with regulatory expectations.
- Apply external scientific and regulatory information to development strategies and business practices.
- The Toxicologist must design/critically evaluate and interpret experiments, record, tabulate and report results and significant issues. The Toxicologist must understand and follow established procedures and practices, ensure compliance with established procedures within the function, as well as possess a good understanding of appropriate FDA, ICH and OECD regulations and guidelines.
The level of this opportunity will be commensurate with experience.
PhD or equivalent in Toxicology or closely related field, post-doctoral training and 2-3 years’ toxicology study director experience in pharmaceutical or contract research organization setting is a mandatory requirement.
Strong verbal and written communication skills to effectively communicate scientific data, issues and conclusions; work within small teams and in a matrix reporting structure environment; lead scientific issue identification and resolution.
Previous responsibility for GLP and non-GLP study conduct and project science within his/her area of expertise on one or more project teams. Demonstrates Toxicology expertise with agility, accountability and excellent communication skills.
Demonstrates the ability to resolve study design and regulatory issues and key project hurdles and assumptions by effectively utilizing available information and technical expertise.
Effective writer and communicator of research or other regulatory materials.
Proactively seek relevant information in the literature and incorporate this into knowledge of Toxicology practices and overall program issues.