Staff Scientist, Translational (PBPK) Modeling & Simulation

Location
San Francisco, CA, United States
Posted
Jul 12, 2018
Ref
2-1-3208-341-2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Summary:

Develops predictive models using the PBPK approach to address preclinical and clinical development
questions pertaining to different therapeutic areas with a focus on oncology and immunology.
Works in close partnerships across various functions including Translation Sciences, Preclinical and Clinical Pharmacology. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities:

Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible factors. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. Utilize physiologically-based pharmacokinetic (PBPK) modeling and simulation approaches using SimCyp software packages as well as other in silico methodologies to guide conceptualization and selection of new proprietary drug candidates based on Nektar's large- and small-molecule polymer conjugation technology. Responsibilities will also include the application of PBPK/PD modeling analysis to support dose decisions in first in human studies and simulation of drug-drug interactions for quantitative risk assessment. Utilize PBPK modeling as part of the clinical development and registration of Nektar proprietary drug products. Analyze and communicate study results and prepare research reports and summary documents for use in regulatory submissions.

Requirements:

A PhD in a pharmacokinetics or closely related scientific discipline is required. A minimum of 4 years experience for the Sr. Scientist position and 8 years experience for the Staff Scientist position. Experience in designing, analyzing, and reporting nonclinical and clinical drug development studies is required. Post-doctoral work may serve as experience. Experience with application of drug development science (e.g., ADME, PK and PK/PD, methods and simulation, statistics, etc.) to streamline drug development required. Must be proficient in creation and management of datasets and in use of major PBPK software such SimCyp and GastroPlus, PK software such as Phoenix, statistical software such as JMP or SAS. Experience with research in immune oncology, in pediatric drug development, and exposure to neural networks and deep learning tools a plus. 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. Experience in physiology, PBPK/PD modeling and simulation, and good knowledge of the scientific literature in the field is highly desired. The candidate should demonstrate a sound knowledge of PBPK/PD and all aspects of modeling & simulation.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.