Associate Director / Director, Pharmacometrics

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.
Our Clinical Pharmacometrics group is looking for an Associate Director / Director who will be responsible for performing pharmacometric modeling and simulations including but not limited to population PK/PD, (semi-)mechanistic PK/PD, PBPK, and QSP, etc., to support early clinical development for biologics and small molecules. Levels will be commensurate with qualifications and experience.
Essential Functions of the Job (Key responsibilities)
Develop, write, and execute pharmacometrics analysis plans, and deliver reports on results as well as define and drive pharmacometrics contributions to regulatory/submission strategy and related documents.
Provide strategic expertise and leadership for development programs based on relevant technical and disease area knowledge.
Perform PK/PD analyses and/or population PK/PD analyses, interpret and report data to clinical teams and management in a timely manner.
Perform (semi-)mechanistic PK/PD, PBPK, and/or QSP modeling and simulations that yield high value PK/PD information for critical clinical development decisions.
Work with other functions such as clinical development, biostatistics, data management, medical writing, and regulatory affairs, etc., to provide deliverables on time.
Present work internally and at external scientific meetings and publish manuscripts in peer-reviewed journals.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Ph.D. in Pharmacokinetics, Pharmacometrics, Pharmacology, Pharmaceutical Science, Chemical/Biomedical engineering, Statistics or related fields.
5-10 years post-PhD or 7-12 years post-MSc of experience in population PK/PD analysis, PBPK, and/or QSP modeling and simulations.
Levels will be commensurate with qualifications and experience.
Expertise in multiple software packages such as R, NONMEM, Monolix, MatLab, Simcyp, GastroPlus, or other pharmacokinetic, modeling and data visualizations software.
Expert knowledge and evidence of hands-on experience in the application of modeling and simulation methods to drug development.
Scientific understanding of biopharmaceutical and ADME properties of both small molecules and biologics
Experience with clinical pharmacology, human biomarker validation and development, and Phase 1, first-in-human or proof of concept clinical trials;
Record of significant and successful contributions to regulatory submissions, such as CTAs and/or NDA/sNDA/MAA, and other regulatory agency interactions;
Experience in planning, scheduling, and execution of multiple programs and projects, in a dynamic and cutting-edge research environment;
Excellent communication skills (verbal and written) and presentation skills
Ability to work independently
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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Job Posting: 1076793

Posted On: Nov 22, 2022

Updated On: Dec 22, 2022

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