Senior Scientist, Toxicology I

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.
  
  Accountability/Scope:
• Responsible for representing Sponsor in 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 business practices and PCS Toxicology strategies.
• 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. The position could be a Sr Sci I or Sr Sci II, Toxicology depending on relevant experience.

• Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)