Principal Research Scientist II

PRIMARY JOB FUNCTION:
This position is in the Toxicology line function within the Preclinical Safety group and will report to the Director, or other senior leader in Toxicology. This role reviews and provides input to genetic toxicology strategies and independently proposes, designs and interprets non-GLP and GLP genetic toxicology studies in support of issue resolution and/or drug submissions to regulatory agencies. This role requires demonstrated effective written and communication skills.

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

Accountable for all aspects of GLP report authorship, including writing and reviewing study reports and preparing assigned components of filing documents that support submissions to global regulatory agencies for drugs in development.

POSITION ACCOUNTABILITY / SCOPE:
Responsible for all aspects of GLP compliance within assigned studies and related departmental activities. Independently design and assure the conduct and reporting of genetic 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 genetic toxicology Subject Matter Expert must apply strategic and scientific plans 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.