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.
- MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline
- Strong verbal and written communication skills to effectively communicate scientific data, issues and conclusions; independently work within small teams and in a matrix reporting structure environment; lead scientific issue identification and propose appropriate resolution(s).
- Responsible for GLP and non-GLP genetic toxicology study design, interpretation and project science within this area of expertise on one or more project teams.
- Demonstrates Genetic 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, with minimal supervision.
- 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.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.