Job ID: 289605542
Last Updated: 8/8/2018
Clinical Pharmacologist II, Quantitative
Recruiter II, Talent Acquisition
The Clinical Pharmacology Department at Gilead Sciences is seeking a talented Scientist who is driven to understand the clinical pharmacokinetics (PK) and pharmacodynamics (PD) of new and existing compounds. This individual will have a broad portfolio of responsibilities within the department supporting projects in the area of Oncology, Immunology, Cardiovascular and Infectious Diseases.
This individual will have experience of the application of quantitative approaches to drug development. Using state of the art modeling and simulation strategies, this individual will provide pharmacokinetic and pharmacodynamic modeling support to clinical project teams, ensuring critical information regarding the pharmacokinetics (PK), pharmacodynamics (PD), and the interaction between them, of drug candidates are understood and utilized in decision making to support development and registration of therapeutics. Application of physiologically-based pharmacokinetic (PBPK) modeling analysis to support dose decisions in clinical trials and simulation of drug-drug interactions for quantitative risk assessment is a plus.
A Doctorate degree or equivalent in pharmacokinetics, drug metabolism, pharmacology or an advanced quantitative discipline, with at least 3 years of industry and/or related post-doctoral experience.
In-depth conceptual and technical/development expertise in the area of PK/PD or PBPK modeling and simulation.
Working knowledge of pharmacokinetic program and analysis software (such as WinNonlin, NONMEM, R, ADAPT, Monolix, SIMCYP, etc.) along with PK modeling (Population PK, Disease Progression, Bayesian, Clinical Trial Simulations, etc.) and computer skills in scientific graphing.
Experience in authoring documents and reports including documents for submission to regulatory agencies.
Able to assess, prioritize and manage a diverse, time-sensitive workload.
Identify program or study-specific issues. Generate potential solutions and work in a collaborative manner with team having excellent influencing skills.
Excellent written and presentation skills
Develop pharmaco-statistical models including, exposure - response models, biomarker - efficacy models, population PK models, etc., throughout all phases of drug development. Ability to develop or support PBPK modeling will be a plus.
Conduct model based simulations to design studies that yield high value PK/PD/PGx information to aid future critical decisions
Advise and implement Quantitative Clinical Pharmacology aspects of regulatory strategy
Work in partnership with department Clinical Pharmacologist, Bioanalytics and Operations/Project Management peers and cross-functional teams
Present work at professional meetings and publish manuscripts in leading scientific journals
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