Clinical Biomarker Operations Manager

South San Francisco, California 94080 | Contract

Post Date: 03/27/2018 Job ID: 4043 Industry: Product Development, Project Management

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Duties:
  • BioAnalytical Sciences (BAS) develops implements and provides strategic direction for state of the art bioanalytical methods and automation systems. 
  • BAS data and expertise enable the characterization of the pharmacokinetic, immunogenic and in vitro biological activities of  biotherapeutics during drug development and throughout the product life cycle.   
  • The BioAnalytical Manager (BAM) is a project management role in BAS. 
  • BAM works with clinical study teams, contracting group, data group, DMPK, BAS, central labs and contract labs to outsource and manage biosample (PK/ATA) analysis. 
  • The BAM is simultaneously assigned to multiple studies and is an agenda-driven ad-hoc member of the clinical study management team (SMT) for each study. 
  • The responsibilities for BioAnalytical Manager include: Driving the development of assay vendor SOWs, managing vendor contracts, including review of invoices, ensuring receipt of SOW deliverables, resolving or escalating issues where needed, and closing contracts
  • Assist with identifying  and on-boarding assay vendors including SOW development, budget planning, and specifying data formats
  • Preparing vendor oversight plans for each study as needed.
  • Ensuring alignment with cross-functional stakeholders and document team decisions in the PK/ATA Sample Flow Diagram
  • Developing timelines for PK and ATA data for managing contract labs to ensure samples are tested according to protocol/team timelines, data is returned in the specified format, and all SOW specified deliverables are met
  • Overseeing shipping and receipt of biosamples from central labs to assay laboratories Providing biosample metrics and status updates to teams as requested
  • Supporting clinical study teams (PET/SMT), pharmacology teams through attending appropriate meetings as needed
  • Serving as the on-going operational point of contact between internal gRED functions and assay vendors for communication regarding sample logistics and availability, batching and testing timelines, reanalysis, and data reportable tracking
  • Making arrangement for samples and data handling/archiving at the completion of the study

 

 

Skills:

  • Bachelor's degree  or Master's degree in a scientific discipline
  • 5 + years of experience in related field that includes experience working in the biotech industry and in clinical study teams with involvement in the processing and/or analysis of biological samples
  • Ability to deliver results successfully, collaborating with multi-cultural and geographically diverse teams
  • Technical experience/knowledge of bioanalytical assay methods.
  • Ability to work in a highly matrixed organization in a positive and collaborative manner
  • Strong organizational skills with attention to details
  • Independently manage multiple competing priorities, while working on multiple projects simultaneously
  • Excellent communication and presentation skills and effective influencing/negotiating skills.

 

Education:

  • Bachelor's degree  or Master's degree in a scientific discipline
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