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)
- Work with toxicology project leads to define toxicology program strategies and timing for all discovery and development projects (small and large molecule), including general toxicology, developmental and reproductive toxicology, genetic toxicology, carcinogenicity and safety pharmacology. Ensure programs align with current global regulatory requirements and industry standards.
- 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. Development and implementation of strategies to mitigate/resolve risk associated with toxicology safety signals.
- Active and proactive participation at the senior level of scientific, strategic, and operational aspects of drug discovery and development within the pharmacology, toxicology, and both early and late stage clinical drug development process.
- Oversight of the writing, review and evaluation of documents for FDA and global submissions. Manage support of regulatory filings with worldwide regulatory authorities from IND/CTA through NDA/BLA/MAA.
- 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.
- Support business development via review/due diligence of potential external assets.
- Support CMC as needed through safety evaluation of impurities, extractables/leachables, occupational safety evaluations (OELs, PDEs), and environmental risk assessments
- Manage a team of PhD toxicologists (project leads), pathologists, in-life scientists and laboratory animal staff.
- 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 or related field. DABT certification desired.
- 15+ years related experience at director level or above in the pharmaceutical industry or related function.
- Management experience
- 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.
- In depth understanding of global regulatory requirements, industry standards, and emerging trends in toxicology. 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 both oncology and non-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.
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