Pharmacometrics Manager

Pharmacometrics Analyst

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

As a Pharmacometrician your main role should be performing a variety of pharmacometrics analyses at Gilead. You will have unparalleled opportunity to be involved with several aspects the product development process. From first-in human dose projections in partnership with DMPK through approval and post-marketing activities, you will provide input into a breadth of products across Gilead portfolio. We seek to provide a rewarding career and a continuous learning experience.

This is an onsite position that can be based at our Foster City, California location.

Responsibilities

• The candidate will be exposed and mentored on the development and implementation of clinical pharmacology and modeling/simulation strategies for small/large molecules in all stages of drug development.
• The candidate should possess strong quantitative skills, conceptual, technical and hands on development expertise with modelling and simulation activities (population modelling, PK, E-R, literature meta-analyses, Clinical Trial Simulation, etc). The candidate should be familiar with modeling and simulation software programs such as (NONMEM, R, LATEX, MATLAB, etc). Experience on the 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.
• Candidates will grow on the role with the goal of being able to anticipate problems that may occur in clinical trials and develop solutions for them using precedents or original thinking. The Pharmacometrician will work with the Clinical Pharmacologist regarding optimal implementation and conduct of clinical pharmacology studies, analysis, interpretation and reporting of clinical pharmacology summaries and modeling report to support regulatory queries, interactions and NDAs/BLAs.
• The candidate will contribute to and represent the department on multifunctional project teams.
• Excellent verbal, written, and interpersonal communication skills and ability to convey moderately complex technical information clearly to others are required.
• In-depth knowledge and understanding of the regulatory requirements for quantitative analysis, MIDD, and MI3 pilot programs is a plus.

Basic Qualifications:

• 0+ years of experience and an MD, PhD or PharmD degree in pharmacokinetics or a related scientific discipline.
• OR
• 7+ years of experience and BS
• OR
• 5+ years of experience and an MS

Preferred Qualifications:

• 0+ years of experience and an MD, PhD or PharmD degree in pharmacokinetics or a related scientific discipline.
• Working knowledge of pharmacokinetic program and analysis software (such as WinNonlin, SAS etc.) along with PK modeling and computer skills in scientific graphing. Normally receives general instructions on non-routine work and detailed instructions on routine new assignments.
• Requires a basic understanding of drug development.