at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Associate Director/Director, Toxicology
Job Summary (Primary function)
Develops robust and relevant toxicology program strategies and provides oversight of toxicology programs for small and large molecule investigational drug candidates, including design, execution and report generation of toxicology studies and preparation of regulatory submission documents. Serves as toxicology project lead on discovery and development teams.
Essential Functions of the Job (Key responsibilities)
Develop toxicology programs in conjunction with toxicology management in accordance with global regulatory requirements and to support the clinical development program.
Design, placement and management of appropriate preclinical toxicology studies for investigational agents in accordance with current regulatory requirements, Good Laboratory Practices, and industry standards.
Contribute to the development of strategies to investigate toxicology findings to inform development decisions.
Critical review and interpretation of study data and presentation of results at various forums including working groups, leadership meetings and project development teams.
Preparation of reports and documents for regulatory submissions, including preparation of toxicology and safety pharmacology sections for IND and global marketing submissions, IBs and clinical protocols. Provide responses to regulatory inquiries as needed.
Support other toxicology-related activities as needed (e.g., impurity assessments, OELs, SDS, environmental assessments).
Provide critical assessment of potential safety liabilities related to target pharmacology for new and ongoing drug discovery programs.
Maintain knowledge of current and emerging scientific and regulatory trends and industry standards through review of the scientific literature and/or participation in professional organizations.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Ph.D. in Toxicology or related field.
5+ years of related experience in the pharmaceutical industry or related function.
Knowledgeable in US and global regulatory toxicology requirements and GLP regulations
Experience in investigational toxicology studies, including application of in vitro methods and technologies
Strong written and verbal communication and presentation skills.
Detail-oriented with strong critical thinking and problem-solving skills.
Strong organizational skills with ability to manage multiple priorities with aggressive timelines.
Ability to integrate information from multiple disciplines (e.g., pharmacology, ADME, toxicology) in the interpretation of findings and risk assessment.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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