Principal Research Scientist

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 independently proposes, 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 in vivo toxicology studies (90 % of time) and external sponsor monitor for studies conducted at contract research organizations ( As study director, the incumbent ensures the highest standards in quality and regulatory compliance are met in study conduct and reporting, without supervision.
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.
Independently 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. Develop and sustain networks with key business partners.

POSITION ACCOUNTABILITY / SCOPE:

Responsible for all aspects of GLP compliance within assigned studies and related departmental activities. Independently design, conduct and report toxicology studies appropriate to overall development plans and aligned with regulatory expectations.
Propose and apply external scientific and regulatory information to development strategies and business practices.
The Toxicologist must apply toxicology principles to development programs and functional area needs. The Toxicologist must use his/her scientific judgment to 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.

Requirements:

• Bachelor's Degree in Toxicology or closely related field with extensive (typically16 years) of related work in pharmaceutical or contract research organization setting; OR
  Master's Degree in Toxicology or closely related field or PharmD with extensive (typically 14 years) of related work in pharmaceutical or contract research organization setting; OR
  PhD in Toxicology or closely related field with typically 8-10 years of related work experience in pharmaceutical or contract research organization setting.
• Experience in research and/or development environment.
• Proven ability to innovate with a history of new or improved product releases.
• Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.
• Demonstrated ability to influence others in areas of science.
• Technical background in healthcare, laboratory diagnostics, medical devices or pharmaceutical companies.