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Scientist II

Pharmacyclics LLC


Location:
Sunnyvale, California 94085
Date:
09/20/2017
2017-09-202017-10-20
Job Type:
Employee
Job Status:
Full Time
Pharmacyclics LLC
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Job Details

The translational medicine scientist will be responsible for implementation of overall biomarker strategy and development plans in immunology or immuno-oncology related clinical studies. The candidate will direct and interpret the subsequent analyses of clinical biomarker results and data.  He or she will be responsible for submission of biomarker reports in regulatory filings, internal documentations, external presentations, and publications.

 

Key Accountabilities/Core Job Responsibilities:

 

  • Responsible for strategic development and implementation of plans leading to discovery and clinical translation of study or disease-specific biomarkers.
  • Accountable for the development and execution of biomarker plans according to pre-specified timelines, with specific alignment to the associated clinical study protocols.
  • Ensures that assigned biomarker program budgets, schedules, and performance standards are attained, and that resultant activities and data are reviewed in accordance to regulatory requirements.
  • Undertakes cross-functional engagement with Clinical Science and Clinical Operations for translation of biomarker assays to the clinic. 
  • Manages external groups including clinical investigative sites and external CROs, to ensure the highest quality clinical sample acquisition and sample handling and storage preparatory to execution of biomarker assays, subsequent data analysis and data transfer.
  • Collaborates with the Bioinformatics team to drive biomarker analysis of data generated from Pharmacyclics sponsored studies, and potentially from Investigator Sponsored or Co-Operative group studies, or studies undertaken by potential partners.
  • Develops key external academic or industry collaborations and maintains understanding of emerging concepts and maintains scientific leadership in the field.
  • Participates in review of Investigator Sponsored studies or Co-Operative group studies proposals and provides translational medicine focus feedbacks to study review committee.
  • Provides expertise and written input on biomarker-related sections in clinical study-related and regulatory documents, such as INDs, ICFs, IBs, Clinical Study Reports, ad hoc analyses, etc.

Requirements

  • 4+ years combined industry and postdoctoral experience and expertise in autoimmune disease or cancer immunology fields.
  • Track record of leading cancer immunology or autoimmune disease projects in research or translational medicine.
  • Expertise in multi-colored flow cytometry and/or CyTOF is required.
  • Expertise in one or more of other core clinical biomarker assay technologies such as ELISA, Next Generation Sequencing, RNA expression, immunohistochemistry, in-situ hybridization, histologic and pathologic assessment of samples derived from biological matrices.
  • Excellent organizational skills, collaboration experience, team leadership and communication skills leading to productive interactions between cross-functional colleagues and external collaborators. Ability to deliver under tight timeline.

Experience:  

  • Experience in research and/or development of small-molecule therapeutics for inflammatory diseases and/or oncology applications.
  • Experience in biomarker and associated drug development in a pharmaceutical or biotechnology company setting is strongly preferred.
  • Understanding of lymphoma biology and lymphocyte immunology.
  • Experience in syngeneic and/or transgenic animal models for transplantation, autoimmune diseases, and oncology is preferred.

 

Education Requirements (degree, certifications, etc.):

 

  • Requires a Ph.D./Pharm.D or M.D. (or equivalents), with postdoctoral experience and 2-5 years of productive industry experience in fields of hematology, inflammatory diseases, or oncology. 

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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