Job ID: 4730
Job date: 2015-11-06
End Date:
Company : Pharmacyclics Country : Role : Research Scientist
Job date: 2015-11-06
End Date:
Company : Pharmacyclics Country : Role : Research Scientist
Job Description:
General Position Summary/Purpose:
Contributes to the early/mid/late stage development of drugs in hematology/oncology and/or solid tumors by supporting the implementation of genomic clinical biomarkers for all clinical studies to support the global program team. Interacts directly with biomarker managers, bioinformatics team and interfaces between Research, Clinical and Biometrics Departments. Integrates computational biology, bioinformatics, next generation sequencing, functional genomics to advance drug research and development. Develops key external collaborations and maintains scientific leadership in the field.
Responsible for the implementation of the genomic biomarker strategy, and discovery of biomarkers that correlate with response, and accountable for the timely operational execution of biomarker assessments in hematology/oncology protocols, in compliance with Pharmacyclics processes and regulatory requirements. Specifically, this includes working closely with Research Scientists and Clinical Project Leaders.
Key Accountabilities/Core Job Responsibilities:
Working in the Research Department, develop, establish, and lead efforts aimed at discovery of novel biomarkers with association to clinical endpoints in B lymphoma or cancer studies using genomic platforms. Work with a team of seasoned biomarker managers, wet lab scientists, bioinformatics scientists and provide interpretation from genomics/gene expression studies with correlative endpoints using a deep understanding of clinical genetics and disease biology. Establish functional genomics within subteam, and lead to identify driver mutations/translocations using whole exome sequencing and whole transcriptome sequencing. Lead the development of bioinformatic and pharmacogenomic strategies for the identification of predictive/prognostic signatures from large WES, RNA-seq data sets. Contribute to auditing of external analytical labs, provide input into trial-specific agreements and assess service level commitments of labs involved in biomarker sample analysis. Coordinates between CRO Assay Development group and clinical team, when necessary. Contribute to the biomarker assessments in clinical protocols to develop the central and reference laboratory components. Support TDM for the biomarker data transfer, data reconciliation, and data review. Partner with study biostatisticians, project lead, Research head, and biomarker labs to complete data analyses.
Qualifications:
Demonstrated success in pharmaceutical or biotechnology companies in leading clinical biomarker projects for various programs, preferentially in B cell lymphomas or general oncology. Expertise in genomic profiling, gene expression analysis, SAS/JMP and large data analysis and strong understanding of clinical genetics/genomics. Bioinformatics experience will be a bonus. Understanding of clinical trial designs and clinical operations. Excellent organizational skills, communication skills between research, clinical and biometrics staff. Proven track record in scientific leadership, including publications and invited presentations at major conferences on biomarker correlative studies in clinical trials. Demonstrated experience in accelerating or developing novel clinical applications with the use of biomarker or mechanism –based patient or indication selection Experience:
Ph.D. in clinical cancer genetics or human genetics , or related discipline and 3+ years experience in drug development in a pharmaceutical or biotechnology company with significant expertise in clinical biomarkers in mid/ late stage development Recognized externally as a scientific leader in clinical genetics as evidenced by peer reviewed publications and patents Deep understanding and expertise in NGS, RNAseq, WES, GEP, plasma DNA sequencing of cancer genes preferred. Deep understanding of lymphoma biology or lymphocyte immunology a bonus.
Education Requirements (degree, certifications, etc.):
Requires a Ph.D./Pharm.D or equivalent in Cancer Genetics or Human Genetics/Molecular Biology or Computational Biology
Preferred Skills/Abilities
Experience in genomic analysis and interpretation following WES, WGS, GEP, RNAseq, plasma DNA seq. Strong understanding and proven track record in genomics/genetics technology and applications to clinical development. Computational Biology and Statistics Skills a plus #LI-SR1
Additional Info:
[Click Here to Access the Original Job Post]
General Position Summary/Purpose:
Contributes to the early/mid/late stage development of drugs in hematology/oncology and/or solid tumors by supporting the implementation of genomic clinical biomarkers for all clinical studies to support the global program team. Interacts directly with biomarker managers, bioinformatics team and interfaces between Research, Clinical and Biometrics Departments. Integrates computational biology, bioinformatics, next generation sequencing, functional genomics to advance drug research and development. Develops key external collaborations and maintains scientific leadership in the field.
Responsible for the implementation of the genomic biomarker strategy, and discovery of biomarkers that correlate with response, and accountable for the timely operational execution of biomarker assessments in hematology/oncology protocols, in compliance with Pharmacyclics processes and regulatory requirements. Specifically, this includes working closely with Research Scientists and Clinical Project Leaders.
Key Accountabilities/Core Job Responsibilities:
Working in the Research Department, develop, establish, and lead efforts aimed at discovery of novel biomarkers with association to clinical endpoints in B lymphoma or cancer studies using genomic platforms. Work with a team of seasoned biomarker managers, wet lab scientists, bioinformatics scientists and provide interpretation from genomics/gene expression studies with correlative endpoints using a deep understanding of clinical genetics and disease biology. Establish functional genomics within subteam, and lead to identify driver mutations/translocations using whole exome sequencing and whole transcriptome sequencing. Lead the development of bioinformatic and pharmacogenomic strategies for the identification of predictive/prognostic signatures from large WES, RNA-seq data sets. Contribute to auditing of external analytical labs, provide input into trial-specific agreements and assess service level commitments of labs involved in biomarker sample analysis. Coordinates between CRO Assay Development group and clinical team, when necessary. Contribute to the biomarker assessments in clinical protocols to develop the central and reference laboratory components. Support TDM for the biomarker data transfer, data reconciliation, and data review. Partner with study biostatisticians, project lead, Research head, and biomarker labs to complete data analyses.
Qualifications:
Demonstrated success in pharmaceutical or biotechnology companies in leading clinical biomarker projects for various programs, preferentially in B cell lymphomas or general oncology. Expertise in genomic profiling, gene expression analysis, SAS/JMP and large data analysis and strong understanding of clinical genetics/genomics. Bioinformatics experience will be a bonus. Understanding of clinical trial designs and clinical operations. Excellent organizational skills, communication skills between research, clinical and biometrics staff. Proven track record in scientific leadership, including publications and invited presentations at major conferences on biomarker correlative studies in clinical trials. Demonstrated experience in accelerating or developing novel clinical applications with the use of biomarker or mechanism –based patient or indication selection Experience:
Ph.D. in clinical cancer genetics or human genetics , or related discipline and 3+ years experience in drug development in a pharmaceutical or biotechnology company with significant expertise in clinical biomarkers in mid/ late stage development Recognized externally as a scientific leader in clinical genetics as evidenced by peer reviewed publications and patents Deep understanding and expertise in NGS, RNAseq, WES, GEP, plasma DNA sequencing of cancer genes preferred. Deep understanding of lymphoma biology or lymphocyte immunology a bonus.
Education Requirements (degree, certifications, etc.):
Requires a Ph.D./Pharm.D or equivalent in Cancer Genetics or Human Genetics/Molecular Biology or Computational Biology
Preferred Skills/Abilities
Experience in genomic analysis and interpretation following WES, WGS, GEP, RNAseq, plasma DNA seq. Strong understanding and proven track record in genomics/genetics technology and applications to clinical development. Computational Biology and Statistics Skills a plus #LI-SR1
Requeriments :
Skills :
- Bioinformatics
- Biology
- Computational Biology
- Genetics
- Microarray
- Next Generation Sequencing
- RNA-seq
- Statistics
Areas :
Additional Info:
[Click Here to Access the Original Job Post]