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Associate Director, Research Biology (Nonclinical PK-PD Modeling & Simulation)

Company: Nektar Therapeutics
Location: San Francisco
Posted on: June 12, 2021

Job Description:

Supports Research (Pharmacology, Toxicology, and Chemistry) and Nonclinical PK-PD by developing predictive PK-PD models designed to inform dose and dosing regimen throughout the nonclinical testing program. Uses Ordinary Differential's to describe interactions of the drug candidate with target proteins, temporal variation during treatment, and possible interactions with co-medications. Leverages knowledge and understanding of the use of interspecies scaling methods and PBPK to translate results across species and predict a suitable dose and schedule in first in human clinical study. Works in close partnerships across various functions, including Research, Clinical Development, and Regulatory to identify and advance clinical development candidates.

The AD, Research Biology works collaboratively on complex problems which require a holistic approach. This individual exercises judgment within broadly defined practices and policies in selecting drug candidates, and may recommend new methods, techniques, and evaluation criteria for obtaining results. Duties include but are not limited to writing technical reports, communicating study results and interpretation to project teams, and providing documents for regulatory submissions. The successful candidate will have published PK-PD models in peer-reviewed journals and conference abstracts.

A PhD in Pharmacometrics, Pharmaceutical Sciences, Biomedical Engineering, Biostatistics is required. Equivalent experience may be accepted. Experience with small molecules and biologics is a must. Prior hands on experience with Immuno-oncology is desirable. A minimum of 10 years of relevant work experience in applying quantitative modeling to analyze and report nonclinical is required. Post-doctoral work may serve as experience. Demonstrated success in technical proficiency, scientific and/or medical creativity, collaboration with others and independent thought. Must have sound knowledge of modeling principles and possess strong computational skills. Must be proficient in at least one of the following: Phoenix WinNonlin, Matlab and its toolboxes, Berkeley Madonna, Nonmem, Monolix. Experience applying drug development science (e.g., ADME, PK and PK/PD methods and simulation, statistics, etc.) to streamline drug development is desirable. Strong written and verbal communication skills are required; must be able to independently create high quality written reports and summary documents for use in regulatory submissions.

Keywords: Nektar Therapeutics, San Francisco , Associate Director, Research Biology (Nonclinical PK-PD Modeling & Simulation), Other , San Francisco, California

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