Sr. Clinical Pharmacologist

Location: Foster City, California US

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Job Number: 2099

External Description: Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

Job Description
The Clinical Pharmacology Department at Gilead Sciences is seeking a talented scientist who is driven to understand the clinical pharmacology properties of small and large molecule candidates using state of the art clinical pharmacology science. The level of the position is flexible from Clinical Pharmacologist to Sr. Clinical Pharmacologist II

This individual functions as the Clinical Pharmacology representative on cross-functional biotherapeutic and small molecule project teams from Phase I-IV and is responsible for all aspects of clinical pharmacology support: design of overall clinical pharmacology and pharmacometrics plan for projects, design, execution, analysis, and reporting of clinical pharmacology studies, input into clinical pharmacology aspects of other studies, analysis of study-level and integrated data using non-compartmental and population modelling strategies, and communication of data in regulatory documents and meetings. This position will report to the Senior Director, Clinical Pharmacology.

At Gilead, it's our employees' dedication to science and the lives of patients living with life-threatening diseases around the world that motivates our team to success, discovery, & curiosity. This is an opportunity to join a team as we are revolutionizing healthcare by bringing urgently needed medicines to patients in the unmet areas of HIV/AIDS, Immunology, Liver diseases, Hematology and Oncology, and more.

This individual will:

  • Provide leadership and demonstrate accountability for the clinical pharmacology programs supporting Phase 1-4 clinical development for development compounds in your therapeutic area(s)
  • Perform hands-on analysis and interpretation of clinical PK/PD data, including developing population PKPD models, and running clinical trial simulations. Also disseminate the relevant risk/benefit implications to the project teams.
  • Design and execute clinical pharmacology studies; perform hands-on NCA and report results from studies. Contribute to various documents such as protocols, Investigator's Brochure, and other regulatory documents.
  • Collaborate with biostatisticians, clinicians, bioanalytical scientists, sample management colleagues, and clinical operation managers for the appropriate design of Phase I-III studies.
  • Develop clinical pharmacology strategy for projects at all stages of development - Ph1 to NDA/BLA - and to defend these strategies at internal and external meetings.
  • Present work at cross-functional teams, internal and external professional meetings and publish manuscripts in leading scientific journals .
  • Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs


Position Requirements:
  • An advanced degree or equivalent in pharmacokinetics, drug metabolism, pharmacology or an advanced quantitative discipline. The number of years of experience will be a factor in determining the level of the position.
  • Strong hands-on experience in pharmacometric analyses (e.g., population pharmacokinetics, exposure-response and disease progression) using modeling software like NONMEM, Matlab, S-PLUS/R and, SAS or similar software.
  • Good understanding of various aspects of clinical pharmacology science and its role in drug development for both small molecules and biotherapeutics.
  • A pplication 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.
  • Ability to assess, prioritize and manage a diverse, time-sensitive workload.
  • Excellent written and presentation skills.
  • Self-starter with strong sense of curiosity, and ability to rapidly learn from other clinical pharmacology and external members
  • Expected level of autonomy in delivery will depend on the level

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Number: R0014985

Community / Marketing Title: Sr. Clinical Pharmacologist

Location_formattedLocationLong: Foster City, California US

 

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