Project Manager, Translational Medicine

Our Gene Therapy client in Cambridge, MA is growing and looking to add a Project Manager, Translational Medicine to their Biological Development department!  This group supports the progress of clinical development in hemoglobinopathies and immuno-oncology therapeutic areas. Successful candidate will interact cross-functionally with the clinical, research and external contract research organizations to facilitate clinical assay development, transfer, validation and sample testing.  Other responsibilities include but not limited to: 

 

  • Manage clinical assay transfer, validation and sample testing in CROs to advance clinical development in hemoglobinopathies, ocular and immune-oncology therapeutic areas
  • Efficiently maintain timeline of milestones for studies, develop gantt charts, timelines to ensure proper overall execution of clinical assays
  • Interact with external partners and follow the relevant regulatory agency guidelines to transfer assays in support of clinical trial development
  • Review all site-facing assay related manuals, laboratory specification agreements, validation specifications, and processes for assay development that follow CLIS/GCP/GLP regulations
  • Participate in cross-functional clinical trial meetings, identify key areas of risk to advance validation of clinical assays and operation of clinical trial samples at CROs
  • Review validation plan, reports and data transfer plan for regulatory submissions, electronic data capture and data transfer to clinical sites

 

Requirements:

  • Bachelors or Masters Degree in Biology or relevant life science degree; with minimum 5+ years of hands-on industry clinical trial experience in CRO management, assay operations and data transfer
  • Experience with CRO management in clinical assay transfer, clinical sample testing and data management.
  • Experience in analytical assay validation of hematology, molecular, immunological assays, ELISA and cell-based assay is a plus
  • Working experiences with biologics, human tissue samples, nucleic acid, gene and cell therapies is highly desirable
  • Ability to think critically and work independently within a matrixed organization
  • Proficiency with project management tools, analytics and visual reporting applications
  • Excellent oral and written communication skills