Director, Diagnostics R&D

Organization
HealthTell
Job Location
2420 Camino Ramon, Ste 125
San Ramon, CA 94583
Salary
DOE
Benefits

Full comprehensive benefits with 5 weeks of PTO.

Job Description

We are seeking a Director of Diagnostics R&D with significant experience in biomarker discovery and validation, characterization and optimization of protein reagents with immunoassays, label-free binding assays, cell-based assays, and enzymatic assays and developing protein-based assays for clinical applications. The candidate will take a leading role in establishing diagnostic application strategy, developing and validating immunoassays and execution of the overall strategic plan. The candidate will be expected to work efficiently with cross-functional teams. 

 

 

Responsibilities

  • Lead team of professionals developing and validating Immunosignature tests for a range of clinical applications. 
  • Define programmatic diagnostic strategic goals, develop detail plans to achieve goals and be responsible for plan execution
  • Guide efforts toward furthering the scientific understanding of the Immunosignature technology, explore new applications and optimize clinical applications
  • Execute internal and partner sponsored diagnostic application projects
  • Participate in cross-functional workflows and provide scientific guidance to teams
  • Apply new cutting-edge technologies to improve testing throughput and capacity
  • Perform method transfers to other groups and external partners
  • Thoroughly analyze results and methods, solve analytical problems, troubleshoot assays and meet regulatory expectations
  • Prepare and review standard operating procedures, method development reports, qualification/validation protocols and reports, and scientific journal publications and presentations.
  • Write, edit, and review project proposals and reports for clients
  • Interact with diagnostic program partners as needed
  • Present scientific findings at internal and external meetings
Requirements

Education and Experience

  • Ph.D. in Chemistry, Biochemistry, Analytical Chemistry, Bioanalytical Chemistry or related field.
  • 10+ years of Diagnostic or BioPharma industry experience in biomarker research and development or developing assays to characterize proteins, monoclonal antibodies, antibody drug conjugates or fusion protein drug products.
  • Exceptional Scientific leadership experience.
  • Experience leading Scientists developing and validating bioassays, immunoassays including ELISA, or SPR assays.
  • Expertise developing advanced binding, functional or structural assays. 
  • Experience contributing to IVD, IND, NDA or BLA regulatory submissions desired.
  • Experience working on technology transfer and validation activities.
  • Experience developing multi-marker assays or products is desired.
  • Good understanding of statistical tools and knowledge of DOE and design control principles
About Our Organization

About HealthTell:

HealthTell is a Life Sciences and Biotechnology company that is commercializing the ImmunoSignature™ technology for accurate and timely detection, monitoring, and progression of chronic diseases. Based on a robust, scalable, proprietary technology, the company will provide the first and only diagnostic platform capable of detecting the presence of disease, stratifying patients, and monitoring disease progression. The ImmunoSignature™ technology is unlike any other, measuring the immune system instead of relying on inaccurate biomarkers or radiographic images.

HealthTell will empower physicians to make more informed decisions by providing the medical community with tools that will facilitate improved outcomes for patients with chronic diseases. Over 170 million people, in the US alone, are affected by chronic and debilitating diseases that create significant economic burden totaling over a trillion dollars. HealthTell is committed to improving the lives of patients through the power of ImmunoSignature™ Technology.

HealthTell is an equal opportunity employer.

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