Senior Scientist, Toxicology I

Actox; Chicago (IL); Hybrid; USD 180,000 - 240,000; Full time

Job summary

AbbVie seeks a GLP Study Director to oversee internally conducted toxicology studies (80%) and monitor external CRO work (<20%). You will ensure quality and regulatory compliance in study conduct, and lead GLP report authorship and filings for global submissions. The role requires serving as a scientific expert during audits and project teams.

The position involves designing and conducting toxicology studies, applying regulatory information to development plans, and communicating key findings. Depending on experience, level may be Sr Sci I or Sr Sci II, with strong writing and regulatory skills.

Qualifications

• Bachelor’s degree or higher with relevant experience.
• PhD in Toxicology or related field preferred.
• Experience with GLP and non-GLP study conduct.
• Strong written and verbal communication skills.
• Ability to resolve study design and regulatory issues using available information.

Responsibilities

• Function as GLP Study Director for toxicology studies (80% internal, <20% external).
• Ensure high standards of quality and regulatory compliance in study conduct and reporting.
• Authorship of GLP reports and preparation of filing documents for global submissions.
• Serve as scientific expert for audits, project teams, and regulatory discussions.
• Design, conduct and report toxicology studies aligned with development plans and regulatory expectations.

Skills

Toxicology expertise

Excellent communication

Regulatory knowledge

Auditing experience

Report writing

Education

Bachelor's degree

Master's degree

PhD in Toxicology

Job description

ICompany Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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)

Qualifications

• Bachelor's Degree or equivalent education and typically 10 years of experience, Master's Degree or equivalent education and typically 8 years of experience, PhD and no experience necessary.
• PhD or equivalent in Toxicology or closely related field with or without, post-doctoral training and up to 4 years toxicology study director experience in pharmaceutical or contract research organization setting is preferred.
• Responsible for GLP and non-GLP study conduct and project science within his/her area of expertise.
• 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.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html