The Principal Research Scientist is responsible for the conduct of toxicology and safety pharmacology studies, as well as preclinical evaluations of compounds under development at AbbVie. Provides strategic input for toxicology safety assessment activities related to drug discovery, drug development, regulatory, and marketing commitments. Contributes to departmental administrative responsibilities, as well as providing guidance and possibly mentoring to others either in toxicology or other departments. This position will be supporting projects in Eye Care and other therapeutic areas such as Aesthetics and Neurotoxins.
This role ensures the establishment of optimal toxicology development plans for new chemical, bio-therapeutics or product opportunities, and the implementation of these plans, based on project priorities to ensure orderly and timely progression within set target dates, through in-house or contract research organizations in full compliance and adherence with FDA, USDA and GLP regulations.
This position has responsibility for ensuring high quality, interpretation, integration and risk assessment to all related data to draw valid conclusions in support of product safety and dose selection for initiating clinical investigations or regulatory submissions. The Principal Research Scientist I authors toxicology and safety pharmacology sections and contribute to efficacy and safety sections of INDs, NDAs, BLAs, IBs for worldwide regulatory submissions, and coordinates and reviews technical responses to regulatory questions.
The individual will participate in due diligence reviews of drug products to identify potential risks and provide recommendations for partnership or in-licensing.
The position functions as a resource on safety related regulatory issues, formulation selection, review of program/project development strategies, clinical dose selection/protocol and potential product or technology acquisitions. Maintains strong technical contacts with contract research laboratories, and regulatory agencies, and establishes strong cross functional working relationships with other R&D functions with the aim of integrating plans between multiple disciplines.
Scientific degree in toxicology, pharmacology, or related field is required.
MS with typically 12+ years of experience or PhD with typically 6+ years of experience in nonclinical safety assessment in the pharmaceutical or biotechnology industry
Strong knowledge of regulatory requirements, including GLP, FDA, and ICH guidelines
Experience in designing, monitoring, interpreting and effectively communicating nonclinical safety studies
Experience in developing toxicology programs to support early and late stage drug development and in preparing regulatory filings such as INDs/NDAs/MAAs
Certified Diplomate of the American Board of Toxicology is a plus
Excellent organizational and interpersonal skills and verbal and written skills
Ability to work in a matrix organization. Computer and software skills.
Ability to travel 5 – 10% of time
**Applicable 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 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.