Remote: Biomarkers Assay Development Consultant (232058)

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Job Description:

 

Our pharmaceutical client is looking for a Biomarkers Assay Development Consultant with a laboratory background.  There is one SME in this role currently but needs assistance with the workload. This person should have knowledge of GLP and GCP, specifically within a lab.  Must have an understanding of clinical trials, quality and compliance. The ideal candidate will have an understanding of experimental methodologies associated with biomarkers. They will need to maintain scientific excellence in biomarkers, assay implementation and validation, patient characterization, and companion diagnostics. They need to be capable of applying the highest scientific and technical standards for the successful design and execution of clinical biomarker assays.

 

Job Requirements:

 

Mandatory requirements: 

 

  • Understands clinical trials (Phase I-III) i.e. safety, efficacy, powered efficacy, and post marketing commitments.
  • Understands and can apply the CDx development process steps from early research to commercialization; what clinical validation, analytical validation activities are needed at each stage of a clinical trial. How they are documented in a IVD Dx manner. 
  • Precision medicine background (types of functional biomarkers). Knowledge of FDA BEST guidance and references built into the BEST guidance. -And the QC and standards, guidances integrated into these assays.
  • How to qualify clinical biomarkers in a fit for purpose manner to ensure required due diligence QA documentation practices in clinical trials. 
  • Experience with GCP compliance in a clinical trial setting, specifically for use of clinical trial endpoints- best practices for documentation (Examples: ICFs, clinical protocol biomarker supporting documentation including SOW, technical performance verification, validation reports, shelf life stability. Documentation of clinical biomarker deviations in process and in clinic and risk mitigation strategies. 
  • Ability to work in a fast paced, highly matrixed, cross-functional collaborative environment
  • Location: Remote 
  • Duration: 1 year + 
  • Start Date: ASAP
  • Skills: Biomarkers, GLP/GCP, laboratory, clinical, compliance

 

Preferred but not required:

 

  • Writing GCP Biomarker SOPs, WI, and forms 
  • Clinical trial experience 
  • Surrogate endpoint validation and qualification.
  • CLIA qualifications and LDT development.
  • Familiarity w/a wide range of molecular and cellular methods (NGS, Flow, etc.)
  • Experience as an SME within a molecular or cellular technology.

 

Remote: Biomarkers Assay Development Consultant (232058)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote

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