Principal Research Scientist II, Toxicology

Company: Initial Therapeutics, Inc.
Location: Irvine
Posted on: March 29, 2025

Job Description:

Company DescriptionAbbVie'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, as well as products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , and .Job DescriptionWe 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
  • 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!Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
    • 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.
    • This job is eligible to participate in our long-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, serving our community and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status.US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Keywords: Initial Therapeutics, Inc., Irvine , Principal Research Scientist II, Toxicology, Other , Irvine, California