Vice President, Toxicology

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.

Job Summary (Primary function)
The Vice President, Toxicology oversees and manages the toxicology function within Discovery Biology in support of the organization's goals and mission. The VP manages all activities associated with safety evaluation of small and large molecule new chemical entities, lead risk mitigation strategies, support of worldwide regulatory filings and effective communication across functions within the organization.

Essential Functions of the Job (Key responsibilities)

• Effective and resource/time-efficient translation of discovery small and large molecules to IND/IMPD/NDA/CTA filings and into clinical development.
• Active and proactive participation at the senior level of scientific, strategic, and operational aspects of drug development within the pharmacology, toxicology, and early stage clinical drug development process.
• Evaluation of the risk associated with toxicology/safety signals (earliest possible time) and the effective communication of the impact of the safety signal to the organization.
• Ensure compliance by following company policies, SOPs, and regulations for internal and external activities, as applicable.
• Development and implementation of strategies to mitigate/resolve risk associated with toxicology safety signals.
• Manage support of regulatory filings with worldwide regulatory authorities from IND/IMPD through NDA/CTA.
• Communication (written and oral) with regulatory agencies in response to questions arising from regulatory submissions; review and evaluation of documents for FDA and global submissions; and representing Incyte at health authority meetings.
• Oversight of the writing, review and evaluation of documents for FDA and global submissions.
• Support business development via review/due diligence of potential external assets.
• In-depth understanding of in vivo and in vitro biology, particularly molecular pathways in assessing risk and solving experimental questions in both pharmacology and toxicology.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Ph.D. in Toxicology.
• 15+ years related experience at director level or above in the pharmaceutical industry or related function.
• DABT certification.
• Demonstrate skills in written and verbal communications; organized and detail oriented.
• Demonstrate a thorough understanding of ADME, CMC and clinical functions, and ability to communicate effectively across disciplines in order to facilitate understanding and rapid resolution of issues.
• Experience in filing IND/CTAs and NDAs for small and large molecules.
• Experience in developing risk mitigation strategies for emerging safety signals and communicating impact of signals in the context of oncology drug development.

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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