AbbVie

Director, Toxicology

Employer
AbbVie
Location
Irvine, CA, United States
Posted
Nov 14, 2020
Ref
203530
Discipline
Science/R&D, Toxicology
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Director of Toxicology in the Non-Clinical and Translational Sciences (NTS) department is responsible for the conduct of toxicology and safety pharmacology studies as well as preclinical evaluations of compounds under development. Provides leadership and strategic input for toxicology safety assessment activities related to drug discovery, drug development, regulatory, and marketing commitments. This position will be supporting projects in Eye Care and other therapeutic areas such as Aesthetics and Neurotoxins. Knowledge and experience in ocular toxicology is desirable.
This role ensures the establishment of optimal toxicology development plans for new chemical, bio-therapeutics or product opportunities, and the implementation of these plans 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. He/she authors toxicology and safety pharmacology sections and contributes to efficacy and safety sections of INDs, NDAs, BLAs and CTDs for worldwide regulatory submissions, prepares the toxicological portion of corporate data sheets and IBs 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 The Director evaluates published and unpublished data and provides risk evaluation on new ingredients, impurities and leachables for regulatory submissions, clinical trials and post-marketing support
He/she establishes strong cross functional working relationships with other R&D functions with the aim of integrating plans between multiple disciplines. The Director is also responsible for collaboration with function heads within NTS and maintains strong technical contacts with contract research laboratories, regulatory agencies, and professional societies.
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.
The candidate has a comprehensive understanding of the related disciplines i.e. pharmacokinetics and drug metabolism and pathology.

Qualifications

PhD or DVM with 8+ years of relevant technical experience in Toxicology, Pharmaceutical Industry, and/or drug development or MS with 10+ years of equivalent experience. Experience in ocular toxicology desirable.
Knowledge of GLP/ICH guidelines and FDA regulations and guidance
External recognition of expertise in terms of peer-reviewed publications, invitations to speak at scientific symposiums, or trade association committee assignments is preferred
Excellent understanding of the drug development process
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

Travel
Yes, 15 % of the Time

Job Type
Standard

Schedule
Full-time

Equal Employment Opportunity
At Allergan, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.