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Associate Director/Director, Toxicology

Company: AbbVie, Inc
Location: Irvine
Posted on: June 4, 2021

Job Description:

About AbbVie AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. JOB SUMMARY: The Associate Director/ Director of Toxicology 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. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures. 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 Associate Director/Director 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. KEY DUTIES AND RESPONSIBILITIES: Serves as departmental representative in project teams, conducts all toxicology and safety pharmacology studies required to support drug development, and coordinates with cross-functional departments within the company. Ensures high quality and integrity of the data as well as proper interpretation and valid conclusions in support of product safety prior to initiating clinical trials in humans and regulatory submissions. Directs and participates in the review of technical data for adequacy, quality, additional testing requirements, cost and timing for development of potential acquisition drugs and new technologies. Prepares, reviews toxicology protocols and reports and toxicology portion of INDs, NDAs, CIB, CDS, BLAs, CTDs. Responds to regulatory questions on safety matters and participates in discussions with the FDA or other ministry of health as needed. Ensures NTS leadership and the R&D management team are fully informed of the progress and scientific endeavors through research memos, special presentations. Participates in the initiation, preparation and review of SOPs and other departmental work practices/aids and prepares project status updates on a regular basis. Manages project-related budget. Evaluates published/unpublished data and provides risk evaluation on new ingredients/impurities/leachable for regulatory submissions, clinical trials in humans and post-marketing support Attends scientific meetings and symposia. Maintains state-of-the-art knowledge of the rapidly developing new in vitro/vivo technologies, global standardization of rapid drug development methodologies, changing regulatory requirements and with literature in the related scientific fields for sound risk management. Qualifications MINIMUM REQUIREMENTS PhD or DVM with 6+ 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 Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel Yes, 10 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, 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.

Keywords: AbbVie, Inc, Irvine , Associate Director/Director, Toxicology, Other , Irvine, California

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