Director, Clinical Pharmacokinetics

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

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 Director, Pharmacokinetics is responsible for all aspects of modeling, simulation and PK analyses.
Essential Functions of the Job (Key responsibilities)
Represent Clinical PK & Clinical Pharmacology in project teams.
Contribute to the strategy for CP studies to support registration.
Conduct modeling, simulation and quantitative exposure-response analyses to recommend dosing paradigm for different phases of clinical development; provide justification for dose selection for pivotal clinical trials.
Responsible for some specific exposure-response analyses, e.g. QTc, effect of renal and hepatic dysfunction etc.
Liaise with biologists and preclinical scientists to come up with structural models for particular mechanisms as it applies to clinical development; collaborate with BioStats, Data Management, Clinical Operations & Medical and have an impact on development projects.
Generate reports for NCA PK, population PK and exposure-response analyses, author section 2.7.2 of NDA, contribute to background packages sent to regulatory authorities to support milestone meetings (e.g EOP2).
Present data and recommendations to project teams, external collaborators and senior management.
Publish in peer reviewed journals.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Ph.D. in an appropriate discipline that lays the foundation for the job functions detailed above; strong background in mathematics/statistics and a deep understanding of molecular biology.
Hands on experience with NONMEM, SAS, R, SimCYP or GastroPlus, other programs.
Hands on experience with pop PK, structural models & PBPK.
7-10 years of related industry and/or FDA experience.
Experience working in a matrix environment.
Appropriate publication record is desirable.
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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We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.        

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Job Posting: 902430

Posted On: Jan 26, 2022

Updated On: Feb 25, 2022