Job Description:
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
The Senior Research Scientist, will be responsible for the development and implementation of biomarker and diagnostic strategies to enable and support the discovery, development and commercialization of medically-differentiated therapies in one of our therapeutic areas (oncology, inflammation, respiratory, and liver disease (encompassing fibrosis and chronic viral disease)). This person will lead the development and implementation of biomarker strategies for individual programs. He/she will provide expertise to discovery and development project teams to ensure access to state of the art thinking on appropriate biomarker technologies, evaluate their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed biomarker and/or diagnostic assays. In addition, he/she will direct the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, safety and other biomarkers) and design, implement and oversee biomarker and diagnostic testing and data analysis.
Essential Duties and Job Functions:
For individual research and development programs, lead both the development of the biomarker and diagnostic strategy development by working with research and clinical research and the execution of that strategy.
• Provide input on biomarker related sections of clinical study protocols, clinical study reports, statistical analysis plans, laboratory manuals, etc.
• Support drug and/or companion diagnostic filing and registration activities, including:
- interpretation and preparation of biomarker results needed for filing purposes
- contribution to preparation of documents required for drug and/or companion diagnostic registration
• Direct the development, outsourcing and validation of clinically applicable biomarker assays
- Design, oversee and implement biomarker and diagnostic testing; closely works with multiple departments including research, clinical research, clinical operations, data management, and biometrics to ensure complete implementation of biomarker strategies
- Collaborate with biostatistics and bioinformatics colleagues to design data analysis plans
- Interpret and communicate biomarker and diagnostic results for informed decision-making
• Present to and participate in Advisory Boards and KOL meetings as needed
Knowledge, Experience and Skills:
PhD in a relevant area of Biology, Cell Biology, or Molecular Biology or related field and a minimum of 7 years of relevant experience. Must have expertise in one or more of the following therapeutic areas: oncology, hematology, immunology, inflammation or liver disease.
• Experience with the discovery, characterization, clinical validation and utilization of innovative biomarkers and potential diagnostics.
• The applicant must have experience implementing biomarkers in clinical studies and biomarker strategy
• Direct experience in development, outsourcing and validation of clinically applicable biomarker assays is required
• A strong applicant will also have experience with various biomarker methodologies such as ELISA, flow cytometry, nanostring, RNAseq, NGS, qPCR, comparative genomic hybridization, and protein arrays
• Excellent verbal communication and interpersonal skills are required.
• The applicant must be able to multi-task and participate effectively in teams in a fast paced environment
• Excellent leadership skills including motivation and delegation
• Strong motivation, attention to detail, and ability to think independently and fully integrate into a high achieving team environment
• High level of business awareness
#LI-RRl
Additional Info:
[Click Here to Access the Original Job Post]
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
The Senior Research Scientist, will be responsible for the development and implementation of biomarker and diagnostic strategies to enable and support the discovery, development and commercialization of medically-differentiated therapies in one of our therapeutic areas (oncology, inflammation, respiratory, and liver disease (encompassing fibrosis and chronic viral disease)). This person will lead the development and implementation of biomarker strategies for individual programs. He/she will provide expertise to discovery and development project teams to ensure access to state of the art thinking on appropriate biomarker technologies, evaluate their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed biomarker and/or diagnostic assays. In addition, he/she will direct the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, safety and other biomarkers) and design, implement and oversee biomarker and diagnostic testing and data analysis.
Essential Duties and Job Functions:
For individual research and development programs, lead both the development of the biomarker and diagnostic strategy development by working with research and clinical research and the execution of that strategy.
• Provide input on biomarker related sections of clinical study protocols, clinical study reports, statistical analysis plans, laboratory manuals, etc.
• Support drug and/or companion diagnostic filing and registration activities, including:
- interpretation and preparation of biomarker results needed for filing purposes
- contribution to preparation of documents required for drug and/or companion diagnostic registration
• Direct the development, outsourcing and validation of clinically applicable biomarker assays
- Design, oversee and implement biomarker and diagnostic testing; closely works with multiple departments including research, clinical research, clinical operations, data management, and biometrics to ensure complete implementation of biomarker strategies
- Collaborate with biostatistics and bioinformatics colleagues to design data analysis plans
- Interpret and communicate biomarker and diagnostic results for informed decision-making
• Present to and participate in Advisory Boards and KOL meetings as needed
Knowledge, Experience and Skills:
PhD in a relevant area of Biology, Cell Biology, or Molecular Biology or related field and a minimum of 7 years of relevant experience. Must have expertise in one or more of the following therapeutic areas: oncology, hematology, immunology, inflammation or liver disease.
• Experience with the discovery, characterization, clinical validation and utilization of innovative biomarkers and potential diagnostics.
• The applicant must have experience implementing biomarkers in clinical studies and biomarker strategy
• Direct experience in development, outsourcing and validation of clinically applicable biomarker assays is required
• A strong applicant will also have experience with various biomarker methodologies such as ELISA, flow cytometry, nanostring, RNAseq, NGS, qPCR, comparative genomic hybridization, and protein arrays
• Excellent verbal communication and interpersonal skills are required.
• The applicant must be able to multi-task and participate effectively in teams in a fast paced environment
• Excellent leadership skills including motivation and delegation
• Strong motivation, attention to detail, and ability to think independently and fully integrate into a high achieving team environment
• High level of business awareness
#LI-RRl
Skills :
Areas :
Additional Info:
[Click Here to Access the Original Job Post]