Pharmacometrics Manager

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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.

Job Description

As aPharmacometrician your main role should be performing a variety ofpharmacometrics analysesat Gilead. You will have unparalleled opportunity to be involved with several aspects the product development process. From first-in humandose projections in partnership with DMPKthrough approval and post-marketing activities you will provide input into a breadth of productsacross Gilead portfolio. We seek to provide a rewarding career and a continuous learning experience.

This is an onsite position that can be based at either our Foster City California site or our New Jersey site.

Responsibilities

• The candidate will be exposed and mentored on the development and implementation ofclinical pharmacology and modeling/simulation strategies for small/large moleculesin all stages ofdrug development.

• The candidate should possess strong quantitative skillsconceptual technical and hands on development expertisewith modelling and simulation activities (population modellingPK E-R literature meta-analysesClinical Trial Simulation etc). The candidate should be familiarwith modeling and simulation software programs such as (NONMEM RLATEX MATLABetc).Experience on the application of physiologically basedpharmacokinetic (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 workwiththe Clinical Pharmacologistregardingoptimalimplementation 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 representthedepartment 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 ofthe regulatory requirements for quantitative analysis MIDD and MI3 pilot programs is a plus.

Experience and Skills:

• 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.

• 0 years of experience and an MD PhD or PharmD degree in pharmacokinetics or a related scientific discipline.

The salary range for this position is:

Gilead considers a variety of factors when determining base compensation including experience qualifications and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus discretionary stock-based long-term incentives (eligibility may vary based on role) paid time off and a benefits package. Benefits include company-sponsored medical dental vision and life insurance plans*.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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