Principal Research Scientist II, Toxicology

2 days ago

Lincoln NE United States Allergan Full time

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

We are seeking a highly experienced Principal Research Scientist II to lead and oversee toxicology and safety pharmacology studies as well as preclinical safety strategy for compounds under development at AbbVie. In this role, you will provide strategic input for toxicology safety assessment activities related to drug discovery, drug development, regulatory, and marketing commitments. This position will support projects in Eye Care, Aesthetics, and Neurotoxins.

Responsibilities:

  • Conduct and oversee toxicology and safety pharmacology studies, ensuring high-quality data interpretation, integration, and risk assessment to support product safety and inform dose selection for clinical investigations or regulatory submissions.
  • Devise and implement toxicology development plans for new chemical, bio-therapeutics, or product opportunities based on project priorities to ensure timely progression within set target dates. Leverage in-house or contract research organizations in full compliance and adherence with FDA, USDA and GLP regulations.
  • Author toxicology and safety pharmacology sections of INDs, NDAs, BLAs, and IBs for worldwide regulatory submissions. Coordinate and review technical responses to regulatory questions.
  • Participate in due diligence reviews of drug products, identifying potential risks and providing recommendations for partnership or in-licensing opportunities.
  • Serve as a resource on safety-related regulatory issues, formulation selection, program/project development strategies, clinical dose selection, and potential product or technology acquisitions.
  • Maintain strong technical contacts with contract research laboratories and regulatory agencies. Establish strong cross-functional working relationships with other R&D functions to integrate plans between multiple disciplines.
  • Provide guidance and mentorship to junior team members in Toxicology and adjacent departments.

Qualifications

  • Bachelor's degree in a related field with 16 years of related work experience; Master's degree in a related field with 14 years of related work experience; PhD in a related field with 8+ years of related work experience.
  • Proven experience successfully leading toxicology programs and authoring sections of related regulatory submissions.
  • Excellent understanding of the drug development process and knowledge of GLP/ICH guidelines and FDA regulations and guidance.
  • Recognized expert in the field, demonstrated through peer-reviewed publications, invitations to speak at scientific symposiums, or trade association committee assignments (desirable).
  • Strong interpersonal and organizational skills, with excellent verbal and written communication abilities.
  • Ability to work effectively in a matrixed organization and collaborate with diverse groups within own function as well as external partners.
  • Willingness to be based from AbbVie's Irvine offices minimally 3 days a week.
  • Ability to travel 5-10% of the time.
  • Board-certification preferred but not required.

Join our team and contribute to groundbreaking research in toxicology and safety pharmacology in support of AbbVie’s diverse pipeline. Apply now to be part of our mission to advance science and improve patient lives

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