Associate Director, Pharmacometrics - Wilmington, United States - InCyte

Description

Overview

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.

We are seeking an experienced and talented Pharmacometrician to join our Clinical Pharmacology & Pharmacometric organization in Translational Medicine.

This individual will contribute to drug development from Phase I FIH to LCM as an emerging leader in the Pharmacometric field.

You will be responsible for all aspects of Pharmacometric analyses for a range of programs and a 'go to' expert within the company for aspects of quantitative clinical pharmacology.

Essential Functions of the Job (Key responsibilities)

• Contribute to Clinical PK & Clinical Pharmacology plans in collaboration with CPP leads and project teams.
• Execute the pharmacometric analyses, such as PKPD, PPK, exposure-response, tumor growth dynamic modeling, or PBPK analyses, and interpret the results to recommend dosing paradigm for different phases of clinical development; contribute to the justification for dose selection for pivotal clinical trials.
• Liaise with CPP leads, Clinical Biomarker leads, and preclinical scientists to come up with fit-for-purpose models pertinent to the clinical development; collaborate with BioStats, Data Management, Clinical Operations & Medical and have an impact on development projects
• Generate reports for PK/PD analyses, population PK, exposure-response analyses, clinical trial simulations, comparator modeling, or PBPK analyses.
• Have a general understanding of global regulatory guidance on various pharamcometrics analyses and reporting.
• 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 pharmacology.

• Hands on experience with NONMEM, R, Phoenix, Monolix, SimCYP, GastroPlus, Matlab, or other programs
• Hands on experience with PK/PD, pop PK, ER, or PBPK.
• 7-10 years or more of related industry and/or FDA experience.
• Experience working in a matrix environment.
• Appropriate publication record is required.