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nasdaq:cala
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calitherabiosciencesinc.applytojob.com
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calitherabiosciencesinc.applytojob.com
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Oct 26th, 2020 12:00AM
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Scientist, Biology
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Open
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South San Francisco
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CA
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USA
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Scientist, BiologyThe Biology department at Calithera Biosciences is seeking a highly motivated scientist to help identify novel biological targets for small-molecule cancer therapy. The ideal candidate will utilize their working knowledge of cancer biology to identify and interrogate novel drug targets, biological pathways, and associated tumor types that may be amenable to intervention with small-molecule therapeutics. The position requires a strong understanding of cancer biology and/or cancer genetics, and experience in biological target identification and chemical lead identification. The ideal candidate will also have a working knowledge of the drug discovery/development process.Company BackgroundCalithera Biosciences is a publicly traded company focused on discovering and developing small-molecule drug candidates directed at first-in-class targets for the treatment of cancer. Our lead product candidate, teleglenastat (CB-839), is an internally discovered first-in-class inhibitor of glutaminase, a critical enzyme in tumor metabolism. Calithera also has an active clinical and pre-clinical research pipeline committed to discovering the next generation of cancer therapeutics.Duties and Responsibilities Utilize available resources to identify and prioritize novel biological targets for cancer therapy.Independently formulate and test hypotheses on the role of biological targets in tumor biology using genetic and pharmacologic tools.Develop quantitative, target-specific biochemical and cell-based assay suitable for high-throughput screening of small-molecule libraries.Support lead-optimization efforts with enzyme, biochemical and cell-based assays.Manage and mentor junior employees.Manage research collaborations with external CROs.QualificationsPhD in chemical biology, cancer biology, biochemistry, biophysics, bioinformatics, cell biology or related discipline with 0 - 2 years post-doctoral or pharma/biotech experience is required.A deep understanding of biological pathways that underlie the cancerous phenotype is required.Demonstrated hands-on experience in the use of genetic methods for biological target interrogation (CRISPR, shRNA, siRNA) is required.Demonstrated hands-on experience in designing, executing and analyzing biochemical and cell-based mechanism of action experiments is required.Experience in developing quantitative biochemical or cell-based assays to support HTS or small-molecule lead optimization efforts is highly desirable.Experience designing and executing high-throughput genetic, chemical-genetic, or synthetic lethality screens is highly desirable.Creativity, good communication, and excellent interpersonal skills are required.Breadth and flexibility to adapt to changing project needs.Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, and disability, marital and veteran status. To apply, please navigate to www.calithera.com/culture.
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Oct 25th, 2020 11:19PM
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Oct 25th, 2020 11:19PM
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Calithera Biosciences
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cala
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calitherabiosciencesinc.applytojob.com
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calitherabiosciencesinc.applytojob.com
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Oct 23rd, 2020 12:00AM
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Scientist, Biology
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Open
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South San Francisco
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CA
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USA
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Scientist, BiologyThe Biology department at Calithera Biosciences is seeking a highly motivated scientist to help identify novel biological targets for small-molecule cancer therapy. The ideal candidate will utilize their working knowledge of cancer biology to identify and interrogate novel drug targets, biological pathways, and associated tumor types that may be amenable to intervention with small-molecule therapeutics. The position requires a strong understanding of cancer biology and/or cancer genetics, and experience in biological target identification and chemical lead identification. The ideal candidate will also have a working knowledge of the drug discovery/development process.Company BackgroundCalithera Biosciences is a publicly traded company focused on discovering and developing small-molecule drug candidates directed at first-in-class targets for the treatment of cancer. Our lead product candidate, teleglenastat (CB-839), is an internally discovered first-in-class inhibitor of glutaminase, a critical enzyme in tumor metabolism. Calithera also has an active clinical and pre-clinical research pipeline committed to discovering the next generation of cancer therapeutics.Duties and Responsibilities Utilize available resources to identify and prioritize novel biological targets for cancer therapy.Independently formulate and test hypotheses on the role of biological targets in tumor biology using genetic and pharmacologic tools.Develop quantitative, target-specific biochemical and cell-based assay suitable for high-throughput screening of small-molecule libraries.Support lead-optimization efforts with enzyme, biochemical and cell-based assays.Manage and mentor junior employees.Manage research collaborations with external CROs.QualificationsPhD in chemical biology, cancer biology, biochemistry, biophysics, bioinformatics, cell biology or related discipline with 0 - 2 years post-doctoral or pharma/biotech experience is required.A deep understanding of biological pathways that underlie the cancerous phenotype is required.Demonstrated hands-on experience in the use of genetic methods for biological target interrogation (CRISPR, shRNA, siRNA) is required.Demonstrated hands-on experience in designing, executing and analyzing biochemical and cell-based mechanism of action experiments is required.Experience in developing quantitative biochemical or cell-based assays to support HTS or small-molecule lead optimization efforts is highly desirable.Experience designing and executing high-throughput genetic, chemical-genetic, or synthetic lethality screens is highly desirable.Creativity, good communication, and excellent interpersonal skills are required.Breadth and flexibility to adapt to changing project needs.Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, and disability, marital and veteran status. To apply, please navigate to www.calithera.com/culture.
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Oct 22nd, 2020 11:15PM
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Oct 22nd, 2020 11:15PM
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Calithera Biosciences
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cala
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calitherabiosciencesinc.applytojob.com
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calitherabiosciencesinc.applytojob.com
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Oct 25th, 2020 12:00AM
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Scientist, Biology
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Open
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South San Francisco
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CA
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USA
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Scientist, BiologyThe Biology department at Calithera Biosciences is seeking a highly motivated scientist to help identify novel biological targets for small-molecule cancer therapy. The ideal candidate will utilize their working knowledge of cancer biology to identify and interrogate novel drug targets, biological pathways, and associated tumor types that may be amenable to intervention with small-molecule therapeutics. The position requires a strong understanding of cancer biology and/or cancer genetics, and experience in biological target identification and chemical lead identification. The ideal candidate will also have a working knowledge of the drug discovery/development process.Company BackgroundCalithera Biosciences is a publicly traded company focused on discovering and developing small-molecule drug candidates directed at first-in-class targets for the treatment of cancer. Our lead product candidate, teleglenastat (CB-839), is an internally discovered first-in-class inhibitor of glutaminase, a critical enzyme in tumor metabolism. Calithera also has an active clinical and pre-clinical research pipeline committed to discovering the next generation of cancer therapeutics.Duties and Responsibilities Utilize available resources to identify and prioritize novel biological targets for cancer therapy.Independently formulate and test hypotheses on the role of biological targets in tumor biology using genetic and pharmacologic tools.Develop quantitative, target-specific biochemical and cell-based assay suitable for high-throughput screening of small-molecule libraries.Support lead-optimization efforts with enzyme, biochemical and cell-based assays.Manage and mentor junior employees.Manage research collaborations with external CROs.QualificationsPhD in chemical biology, cancer biology, biochemistry, biophysics, bioinformatics, cell biology or related discipline with 0 - 2 years post-doctoral or pharma/biotech experience is required.A deep understanding of biological pathways that underlie the cancerous phenotype is required.Demonstrated hands-on experience in the use of genetic methods for biological target interrogation (CRISPR, shRNA, siRNA) is required.Demonstrated hands-on experience in designing, executing and analyzing biochemical and cell-based mechanism of action experiments is required.Experience in developing quantitative biochemical or cell-based assays to support HTS or small-molecule lead optimization efforts is highly desirable.Experience designing and executing high-throughput genetic, chemical-genetic, or synthetic lethality screens is highly desirable.Creativity, good communication, and excellent interpersonal skills are required.Breadth and flexibility to adapt to changing project needs.Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, and disability, marital and veteran status. To apply, please navigate to www.calithera.com/culture.
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Oct 24th, 2020 11:16PM
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Oct 24th, 2020 11:16PM
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Calithera Biosciences
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cala
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calitherabiosciencesinc.applytojob.com
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calitherabiosciencesinc.applytojob.com
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Oct 25th, 2020 12:00AM
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Biomarker Scientist/Biomarker Operations Manager
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Open
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South San Francisco
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CA
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USA
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Biomarker Scientist / Biomarker Operations Manager Calithera Bioscience Inc.’s Biomarker Scientist/Biomarker Operations Manager will work with the Sr. Director of Clinical Biomarkers to provide biomarker operations support across multiple clinical trials in oncology and cystic fibrosis.BackgroundCalithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially starve tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California.Primary ResponsibilitiesThis role will be accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including collection, storage and mobilization, processing, analysis, data delivery and final sample disposition). They will take the primary role in managing vendor relationships and oversight and monitoring budgets and invoicing. This role will also be responsible for authoring documentation related to biomarker studies (eg SOWs, lab manuals, clinical trial protocols) and will support the Clinical Operations team on biomarker-related issues. They will be responsible for analyzing large biomarker datasets and communicating findings to the team, as well as identification and evaluation of new vendors and technologies.Knowledge, Skills and AbilitiesExperience in biospecimen operations, sample management and complianceStrong client relationship management skills Experience with sample tracking tools, databases and data transfer methodsIn depth understanding of biomarker techniques: IHC, flow cytometry, transcriptomic and genomic platformsAnalytical mind able to ask key scientific questions and understand the big pictureDemonstrated knowledge of bioinformatics methodologies and intermediate-level Excel functionsSuperior time management, planning, record keeping and organizational skillsExcels at performing multiple tasks effectively in a fast-paced environmentAdept at working within multi-level teams Ability to collaborate and troubleshoot to solve problemsProfessional inter-personal skills and strong verbal, written and presentation skillsProactive, detail oriented, meticulous, thoroughPreferred QualificationsB.S. or M.S. in the fields of cell and molecular biology or biochemistry4-6 years industry experience preferred, which must include experience in biospecimen managementDemonstrated track record of independent critical thinking and scientific achievement in the area of biological sciences and publications in either peer-reviewed journals or presentations at international meetingsExperience with implementing multiple technology platformsCalithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.To learn more information about this position: www.calithera.com/culture.
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Oct 24th, 2020 11:16PM
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Oct 24th, 2020 11:16PM
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Calithera Biosciences
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cala
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calitherabiosciencesinc.applytojob.com
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calitherabiosciencesinc.applytojob.com
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Sep 5th, 2020 12:00AM
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Manager/Sr. Manager, Statistical Programming
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Open
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South San Francisco
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CA
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USA
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Manager/Sr.Manager, Statistical ProgrammingCalithera Biosciences, Inc. is seeking a highly motivated Senior/Manager/Sr.Manager, Statistical Programmer, depending on experience, to join its Biometrics Department. BackgroundCalithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially starve tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California.Major Responsibilities and Accountabilities Depending on experience, the position can be up to Sr.Manager, Statisical programming.Creates Standards, Macros, Tools, and Processes that improve the efficiency of producing analyses across molecule programs.Oversees CRO and contractors for general programming activities including regulatory filings.Hands on ability to produce SDTM/ADaMs as per CDISC standards and compliance, and TFLs for CSRs, adhoc reports and publications.Experience in NDA filing, including ISS/ISE. Experience is developing or reviewing programming functional SOPs. Collaborates with cross-functional study teams across various of molecules/disease areas, and communicates effectively with team members.Ability to incorporate innovative tools and methods where needed is advantageous.Oncology experience is preferred. Knowledge of biomarker and PK/PD data is advantageous.QualificationsBachelor’s degree (advanced degree preferred) in programming related field (e.g. Statistics, Mathematics, Computer Science, Bioinformatics, etc.). Programming experience with SAS is required (R and other languages would be a plus). Knowledge of clinical development and regulatory filing is required. Efficient hands on programming ability to handle variety of projects and rapidly adapt to changing project and strategic requirements.Ability to manage team and CRO.Continuous learning to increase knowledge in drug development, diverse therapeutic areas, and current technology trends for analyses and visualizations.Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
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Sep 4th, 2020 11:09PM
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Sep 4th, 2020 11:09PM
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Calithera Biosciences
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cala
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calitherabiosciencesinc.applytojob.com
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calitherabiosciencesinc.applytojob.com
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Sep 5th, 2020 12:00AM
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Scientist, Biology
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Open
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South San Francisco
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CA
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USA
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Scientist, BiologyThe Biology department at Calithera Biosciences is seeking a highly motivated scientist to help identify novel biological targets for small-molecule cancer therapy. The ideal candidate will utilize their working knowledge of cancer biology to identify and interrogate novel drug targets, biological pathways, and associated tumor types that may be amenable to intervention with small-molecule therapeutics. The position requires a strong understanding of cancer biology and/or cancer genetics, and experience in biological target identification and chemical lead identification. The ideal candidate will also have a working knowledge of the drug discovery/development process.Company BackgroundCalithera Biosciences is a publicly traded company focused on discovering and developing small-molecule drug candidates directed at first-in-class targets for the treatment of cancer. Our lead product candidate, teleglenastat (CB-839), is an internally discovered first-in-class inhibitor of glutaminase, a critical enzyme in tumor metabolism. Calithera also has an active clinical and pre-clinical research pipeline committed to discovering the next generation of cancer therapeutics.Duties and Responsibilities Utilize available resources to identify and prioritize novel biological targets for cancer therapy.Independently formulate and test hypotheses on the role of biological targets in tumor biology using genetic and pharmacologic tools.Develop quantitative, target-specific biochemical and cell-based assay suitable for high-throughput screening of small-molecule libraries.Support lead-optimization efforts with enzyme, biochemical and cell-based assays.Manage and mentor junior employees.Manage research collaborations with external CROs.QualificationsPhD in chemical biology, cancer biology, biochemistry, biophysics, bioinformatics, cell biology or related discipline with 0 - 2 years post-doctoral or pharma/biotech experience is required.A deep understanding of biological pathways that underlie the cancerous phenotype is required.Demonstrated hands-on experience in the use of genetic methods for biological target interrogation (CRISPR, shRNA, siRNA) is required.Demonstrated hands-on experience in designing, executing and analyzing biochemical and cell-based mechanism of action experiments is required.Experience in developing quantitative biochemical or cell-based assays to support HTS or small-molecule lead optimization efforts is highly desirable.Experience designing and executing high-throughput genetic, chemical-genetic, or synthetic lethality screens is highly desirable.Creativity, good communication, and excellent interpersonal skills are required.Breadth and flexibility to adapt to changing project needs.Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, and disability, marital and veteran status. To apply, please navigate to www.calithera.com/culture.
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Sep 4th, 2020 11:09PM
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Sep 4th, 2020 11:09PM
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Calithera Biosciences
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cala
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calitherabiosciencesinc.applytojob.com
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calitherabiosciencesinc.applytojob.com
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Sep 16th, 2020 12:00AM
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Head (Sr. Director) of Biometrics
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Open
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South San Francisco
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CA
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USA
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Head (Sr. Director) of Biometrics Calithera is seeking a Head of Biometrics to lead and grow the Biometrics function. This will include the oversight of Biostatistics (providing strategic technical leadership and guidance on the design and conduct of clinical studies) and of the Programming and Data Management functions. The ideal candidate will be adept at interacting with various groups both within the company and external to the company. Background:Calithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially starve tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California.Duties and/or Responsibilities: Develop and implement department standards and practices to ensure statistical integrity of project deliverables.Direct the statistical design, conduct, and analysis of clinical trials in all phases.Review protocols and case report forms for soundness of trial design.Review and or author statistical analysis plans for all phases of a trial.Perform and/or review the analysis and interpretation of clinical study results, and collaborate with clinical team to produce interim reports, final reports, and publications.Ensure that the interpretation of data obtained from clinical trials, is accurate, scientifically sound and credible.Direct the development, validation and summary of integrated safety and efficacy summaries.Interact with FDA or EU Regulatory Authority staff to ensure clinical studies meet regulatory requirements.Attend meetings with FDA or EU Regulatory Authority to ensure ongoing agreement on project development.Provide strategic and operational oversight of the Programming and Data Management function, to include managing external vendors and/or building an internal team. Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.Provide guidance and expertise to the clinical development team regarding biostatistics-related subject matter. Develop departmental metrics and tracking systems for statistical analysis plans and data quality assurance.Stay abreast of emerging technologies and concepts related to applied statistical methodology.Qualifications and Requirements:Ph.D. in Statistics or Biostatistics with 10+ years of direct experience in biotechnology industry.In-depth knowledge of statistical analysis methods and results/data presentation formats of oncology clinical data. Advanced knowledge of statistical methods in clinical study designs, clinical data analyses. Experience in design and development of statistical analysis plans, study protocols, clinical study reports.Experience with NDA/BLA filings, preferably as the lead statistician for the filing.Abundant knowledge of clinical operations, data management, and clinical study report preparation workflow. Comfort/experience with oversight of the Programming and Data Management functions.In-depth knowledge of regulatory regulations and guidelines.Clear and effective communication skills to present complex data to project teams including non-statisticians and easy for others to interpret and understand.Excellent interpersonal communication skill to build relationship cross-functionally and collaborate effectively.Strong leadership skill, problem solver and ability to influence business stakeholders on key decision-making process. Proficiency in MS Word, Excel, and PowerPoint and any necessary statistical software. Calithera Biosciences, Inc.is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.To learn more information about this position: www.calithera.com/culture.
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Sep 15th, 2020 11:23PM
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Sep 15th, 2020 11:23PM
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Calithera Biosciences
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cala
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calitherabiosciencesinc.applytojob.com
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calitherabiosciencesinc.applytojob.com
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Sep 17th, 2020 12:00AM
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Head (Sr. Director) of Biometrics
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Open
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South San Francisco
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CA
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USA
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Head (Sr. Director) of Biometrics Calithera is seeking a Head of Biometrics to lead and grow the Biometrics function. This will include the oversight of Biostatistics (providing strategic technical leadership and guidance on the design and conduct of clinical studies) and of the Programming and Data Management functions. The ideal candidate will be adept at interacting with various groups both within the company and external to the company. Background:Calithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially starve tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California.Duties and/or Responsibilities: Develop and implement department standards and practices to ensure statistical integrity of project deliverables.Direct the statistical design, conduct, and analysis of clinical trials in all phases.Review protocols and case report forms for soundness of trial design.Review and or author statistical analysis plans for all phases of a trial.Perform and/or review the analysis and interpretation of clinical study results, and collaborate with clinical team to produce interim reports, final reports, and publications.Ensure that the interpretation of data obtained from clinical trials, is accurate, scientifically sound and credible.Direct the development, validation and summary of integrated safety and efficacy summaries.Interact with FDA or EU Regulatory Authority staff to ensure clinical studies meet regulatory requirements.Attend meetings with FDA or EU Regulatory Authority to ensure ongoing agreement on project development.Provide strategic and operational oversight of the Programming and Data Management function, to include managing external vendors and/or building an internal team. Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.Provide guidance and expertise to the clinical development team regarding biostatistics-related subject matter. Develop departmental metrics and tracking systems for statistical analysis plans and data quality assurance.Stay abreast of emerging technologies and concepts related to applied statistical methodology.Qualifications and Requirements:Ph.D. in Statistics or Biostatistics with 10+ years of direct experience in biotechnology industry.In-depth knowledge of statistical analysis methods and results/data presentation formats of oncology clinical data. Advanced knowledge of statistical methods in clinical study designs, clinical data analyses. Experience in design and development of statistical analysis plans, study protocols, clinical study reports.Experience with NDA/BLA filings, preferably as the lead statistician for the filing.Abundant knowledge of clinical operations, data management, and clinical study report preparation workflow. Comfort/experience with oversight of the Programming and Data Management functions.In-depth knowledge of regulatory regulations and guidelines.Clear and effective communication skills to present complex data to project teams including non-statisticians and easy for others to interpret and understand.Excellent interpersonal communication skill to build relationship cross-functionally and collaborate effectively.Strong leadership skill, problem solver and ability to influence business stakeholders on key decision-making process. Proficiency in MS Word, Excel, and PowerPoint and any necessary statistical software. Calithera Biosciences, Inc.is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.To learn more information about this position: www.calithera.com/culture.
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Sep 16th, 2020 11:38PM
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Sep 16th, 2020 11:38PM
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Calithera Biosciences
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cala
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calitherabiosciencesinc.applytojob.com
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calitherabiosciencesinc.applytojob.com
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Sep 18th, 2020 12:00AM
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Head (Sr. Director) of Biometrics
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Open
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South San Francisco
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CA
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USA
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Head (Sr. Director) of Biometrics Calithera is seeking a Head of Biometrics to lead and grow the Biometrics function. This will include the oversight of Biostatistics (providing strategic technical leadership and guidance on the design and conduct of clinical studies) and of the Programming and Data Management functions. The ideal candidate will be adept at interacting with various groups both within the company and external to the company. Background:Calithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially starve tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California.Duties and/or Responsibilities: Develop and implement department standards and practices to ensure statistical integrity of project deliverables.Direct the statistical design, conduct, and analysis of clinical trials in all phases.Review protocols and case report forms for soundness of trial design.Review and or author statistical analysis plans for all phases of a trial.Perform and/or review the analysis and interpretation of clinical study results, and collaborate with clinical team to produce interim reports, final reports, and publications.Ensure that the interpretation of data obtained from clinical trials, is accurate, scientifically sound and credible.Direct the development, validation and summary of integrated safety and efficacy summaries.Interact with FDA or EU Regulatory Authority staff to ensure clinical studies meet regulatory requirements.Attend meetings with FDA or EU Regulatory Authority to ensure ongoing agreement on project development.Provide strategic and operational oversight of the Programming and Data Management function, to include managing external vendors and/or building an internal team. Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.Provide guidance and expertise to the clinical development team regarding biostatistics-related subject matter. Develop departmental metrics and tracking systems for statistical analysis plans and data quality assurance.Stay abreast of emerging technologies and concepts related to applied statistical methodology.Qualifications and Requirements:Ph.D. in Statistics or Biostatistics with 10+ years of direct experience in biotechnology industry.In-depth knowledge of statistical analysis methods and results/data presentation formats of oncology clinical data. Advanced knowledge of statistical methods in clinical study designs, clinical data analyses. Experience in design and development of statistical analysis plans, study protocols, clinical study reports.Experience with NDA/BLA filings, preferably as the lead statistician for the filing.Abundant knowledge of clinical operations, data management, and clinical study report preparation workflow. Comfort/experience with oversight of the Programming and Data Management functions.In-depth knowledge of regulatory regulations and guidelines.Clear and effective communication skills to present complex data to project teams including non-statisticians and easy for others to interpret and understand.Excellent interpersonal communication skill to build relationship cross-functionally and collaborate effectively.Strong leadership skill, problem solver and ability to influence business stakeholders on key decision-making process. Proficiency in MS Word, Excel, and PowerPoint and any necessary statistical software. Calithera Biosciences, Inc.is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.To learn more information about this position: www.calithera.com/culture.
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Sep 17th, 2020 11:17PM
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Sep 17th, 2020 11:17PM
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Calithera Biosciences
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:cala
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calitherabiosciencesinc.applytojob.com
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calitherabiosciencesinc.applytojob.com
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Sep 20th, 2020 12:00AM
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Sr. Manager/Associate Director, Data Management
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Open
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South San Francisco
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CA
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USA
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Senior Manager/Associate Director, Data Management We are currently recruiting for a Senior Manager/Associate Director, Data Management. This role is accountable for ensuring study start-up, conduct, and closeout are performed according to data management best practice, Standard Operating Procedures (SOPs), and Good Clinical Practices (GCPs), to fulfill all federal and local regulations. Duties include serving as the primary data management liaison with vendors and senior management.Background:Calithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially starve tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California.Responsibilities:Provide supervisory and leadership management to Data Management (DM) as a functional group.Oversee DM vendors to ensure the data are complete, accurate, and delivered within the timelines and budget agreed to.Serve as the Lead DM for clinical studies.Lead the design of the eCRFs and ensure that they support the clinical study objectives.Ensure complete and accurate DM documentation are in place, such as eCRF specifications, eCRFs completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans.Ensure data are reviewed by cross functional team on an on-going basis .Develop data quality review plan and ensure all reviews have been completed and all documentation has been finalized and approved for final database locks in a regulatory-compliant manner.Act as team SME for key systems and processes, and lead process enhancement efforts.Mentor, train, and support data management staff.Budget study cost and manage work and change orders.Ensure compliance with applicable Corporate Policies and procedures.Manage and communicate progress and expectations with cross functional leaders and senior management team.Qualifications:Bachelor's degree in health science or equivalent, with 10+ years of data management experience (Oncology experience highly desirable), including vendor management experience and supervisory experience preferred.Knowledgeable in GCP standards, CDISC standards, FDA and ICH guidelines, and recommended CDM Best Practices.Experience developing and maintaining CDM SOPs.Electronic Data Capture (EDC) experience .Demonstrate effective verbal and written communication.Demonstrate expertise in overseeing vendors and leading teams during data management start-up, conduct, and close out of trials.Must have experience leading matrixed teams.Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. To learn more information about this position: www.calithera.com/culture.
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Sep 19th, 2020 11:16PM
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Sep 19th, 2020 11:16PM
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Calithera Biosciences
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Health Care
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Pharmaceuticals & Biotechnology
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