Associate Director, Research Biology (Nonclinical PK-PD Modeling & Simulation)
Company: Nektar Therapeutics
Location: San Francisco
Posted on: June 12, 2021
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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