Gilead Sciences, Inc.
Senior Associate Scientist, Clinical Pharmacology and Translational Medicine
Gilead Sciences, Inc., Santa Monica, California, United States, 90403
Senior Associate Scientist, Clinical Pharmacology and Translational Medicine
Job Description
The Senior Associate Scientist will support the Translational Medicine Pharmacodynamic Analysis team and laboratory operational activities. As a member of the Clinical Pharmacology - Translational Medicine team, you will be at the intersection of Research and Clinical Development, providing valuable insight into the function of CAR T cells in patients. This role will further involve close collaboration with Clinical and Biomarker Operational teams on patient sample tracking and data quality control. Job Responsibilities Conduct clinical trial biospecimen analysis and data acquisition using multiple immunoassay platforms (i.e. ELISA, MSD, Luminex, Simple Plex Ella) Troubleshoot technical issues and recommend potential corrective actions Perform analytical instrument and software validation activities in a GxP setting Assist Clinical Pharmacology Scientists in identifying and reconciling biospecimen inventory Write, review, and edit technical documents including SOPs, development/qualification protocols and reports Data preparation for safety and regulatory review Develop analysis templates and protocols in a LIMS system Track biospecimen analysis needs and sample inventory using laboratory information management systems (LIMS) Support the transfer of methods internally and to contract-testing labs Develop, qualify, and deploy novel assays for immune biomarker/ cytokine monitoring Guide the selection and implementation of new assay technology capabilities Comparative data analysis with complimentary pharmacodynamic measurements (ddPCR, flow cytometry) Basic Qualifications Master’s and 3+ years of scientific experience OR Bachelor’s and 5+ years of scientific experience OR High School Diploma/GED and 9+ years of scientific experience Preferred Qualifications Degree in immunology, cancer biology or a closely-related field and 4+ years of industry experience Hands-on proficiency with protein profiling technologies, with an emphasis on immunoassays (ELISA, Luminex, MSD, and Simple Plex Ella) Experience working with human clinical samples (i.e.. blood, serum, plasma, cerebral spinal fluid) Experience using visual data science platforms, such as Spotfire, GraphPad Prism, or Rstudio Experience coordinating analysis and communication with vendors/CROs Strong communication and record-keeping skills Familiarity with clinical testing in a GxP environment and/or assay validation parameters Knowledge of electronic record keeping or Laboratory Information Management (LIMS) Experience with clinical biomarker discovery and proteomics Familiarity in the areas of tumor biology, immunology and immuno-oncology and related technical skills (flow cytometry, molecular biology- ddPCR, qPCR, next-generation sequencing, RNAseq, cell culture, PBMC, immune cell isolation or functional T cell assays) Comfort and adaptability to a fast-paced, dynamic and matrixed environment The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us? Hit apply. The salary range for this position is: $112,710.00 - $145,860.00. Kite 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 Current Kite Pharma Employees and Contractors: Please log onto your Internal Career Site to apply for this job.
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Job Description
The Senior Associate Scientist will support the Translational Medicine Pharmacodynamic Analysis team and laboratory operational activities. As a member of the Clinical Pharmacology - Translational Medicine team, you will be at the intersection of Research and Clinical Development, providing valuable insight into the function of CAR T cells in patients. This role will further involve close collaboration with Clinical and Biomarker Operational teams on patient sample tracking and data quality control. Job Responsibilities Conduct clinical trial biospecimen analysis and data acquisition using multiple immunoassay platforms (i.e. ELISA, MSD, Luminex, Simple Plex Ella) Troubleshoot technical issues and recommend potential corrective actions Perform analytical instrument and software validation activities in a GxP setting Assist Clinical Pharmacology Scientists in identifying and reconciling biospecimen inventory Write, review, and edit technical documents including SOPs, development/qualification protocols and reports Data preparation for safety and regulatory review Develop analysis templates and protocols in a LIMS system Track biospecimen analysis needs and sample inventory using laboratory information management systems (LIMS) Support the transfer of methods internally and to contract-testing labs Develop, qualify, and deploy novel assays for immune biomarker/ cytokine monitoring Guide the selection and implementation of new assay technology capabilities Comparative data analysis with complimentary pharmacodynamic measurements (ddPCR, flow cytometry) Basic Qualifications Master’s and 3+ years of scientific experience OR Bachelor’s and 5+ years of scientific experience OR High School Diploma/GED and 9+ years of scientific experience Preferred Qualifications Degree in immunology, cancer biology or a closely-related field and 4+ years of industry experience Hands-on proficiency with protein profiling technologies, with an emphasis on immunoassays (ELISA, Luminex, MSD, and Simple Plex Ella) Experience working with human clinical samples (i.e.. blood, serum, plasma, cerebral spinal fluid) Experience using visual data science platforms, such as Spotfire, GraphPad Prism, or Rstudio Experience coordinating analysis and communication with vendors/CROs Strong communication and record-keeping skills Familiarity with clinical testing in a GxP environment and/or assay validation parameters Knowledge of electronic record keeping or Laboratory Information Management (LIMS) Experience with clinical biomarker discovery and proteomics Familiarity in the areas of tumor biology, immunology and immuno-oncology and related technical skills (flow cytometry, molecular biology- ddPCR, qPCR, next-generation sequencing, RNAseq, cell culture, PBMC, immune cell isolation or functional T cell assays) Comfort and adaptability to a fast-paced, dynamic and matrixed environment The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us? Hit apply. The salary range for this position is: $112,710.00 - $145,860.00. Kite 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 Current Kite Pharma Employees and Contractors: Please log onto your Internal Career Site to apply for this job.
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