Skip to main content

Search jobs

Search jobs

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Scientist I or II, Toxicology

Chicago, Illinois Req ID 2208836 Category Research and Development Division AbbVie

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 (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 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.

POSITION 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.

Qualifications:

Skills and Experience Requirements
Strong verbal and written communication skills to effectively communicate scientific data, issues and conclusions; ability to work collaboratively
within small teams and in a matrix reporting structure environment; lead scientific issue identification and resolution.

Basic Qualifications:
Responsible for GLP and non-GLP study conduct and project science within his/her area of expertise. High level of GLP knowledge. Demonstrates Toxicology expertise with agility, accountability and excellent communication skills. Demonstrates the ability to resolve study design and regulatory issues and key study conduct hurdles 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.

Education Requirements

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 REQUIRED.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

  • Research and Development, Chicago, Illinois, United StatesRemove

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation