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Director, Imaging Project Management @Daiichi Sankyo, Inc.

[Hiring] Director, Imaging Project Management @Daiichi Sankyo, Inc.

Mar 30, 2025 - Daiichi Sankyo, Inc. is hiring a remote Director, Imaging Project Management. đź’¸ Salary: unspecified. đź“ŤLocation: USA.

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Role Description

The Director, Imaging Project Management will be a member of the Functional Excellence Team in Global Oncology Development, working with cross-functional stakeholders to develop and execute the imaging strategy for early and late phase study protocols with imaging-based endpoints. The Director will be a main point of contact for the processes associated with Blinded Independent Central Review (BICR) vendors.

  • Protocol Development:
    • Ensure appropriate imaging strategy (collect-and-hold versus full analysis) applied to study
    • Author imaging sections of protocol
    • Conduct periodic review of standardized protocol language to ensure alignment with current practices and literature
    • Facilitate review of imaging charter, site manual, and communication plan
  • Vendor Engagement:
    • Partner with Procurement and Alliance Management to perform vendor feasibility (RFI)
    • Partner with imaging vendors to standardize documentation, processes, and software applications to ensure consistency across the DS oncology portfolio
  • Quality Monitoring:
    • Screen and select Independent Radiology and Oncology physicians (readers) for assignment to studies based on indication specific BICR experience
    • Regularly monitor reviewer metrics for quality control in support of clinical trial endpoint data
    • Collaborate with Imaging CRO on remediation efforts to ensure independent reviewer calibration
    • Maintain database of readers for assignment to similar studies/indications
  • Cross-Functional Collaboration:
    • Collaborate with clinical team and/or statistical team to perform routine review of BICR data to ensure expectations are met
    • Foster relationships with Operations Leads to identify efficiencies in processes related to scan submission to vendors and communication pathways
  • Scientific Engagement:
    • Develop BICR read processes (e.g., eligibility, verification of disease progression) and edit checks for incoming response assessment data
    • Investigate trends in site/central discordance in response assessments
  • Promote Functional Excellence:
    • Design workflows, identify dependencies, milestones in the conduct of imaging portion of study within internal teams and vendors
    • Perform Lunch and Learn trainings on BICR processes
    • Solicit feedback from stakeholders within the organization to identify pain points, gaps, or opportunities for improvements

Qualifications

  • Master's Degree preferred and PhD preferred or MD preferred
  • 5 years of experience in imaging operations in oncology clinical development of both early and late phase clinical trials
  • Deep knowledge of implementation of oncology
  • At least 15 years in Clinical Research in combined pharmaceutical company and Contracted Research Organization (CRO) environment required
  • 4 or More Years of tumor assessment performed by (1) investigator/site and (2) BICR for both solid tumors and hematological malignancy
  • Extensive experience in BICR reader selection and performance monitoring and improvement
  • Deep understanding of collection and QA of imaging and related non-imaging data from sites to Imaging Vendor to Sponsor
  • Clear comprehension of computation and programming of BICR output (e.g., ORR, PFS, DoR)
  • Familiar with good documentation practices and record retention processes, particularly those used in Biostatistics and Data Management groups

Company Description

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đź“Ť Be aware of the location restriction for this remote position: USA
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Back to Remote jobs  >   Project Management
Director, Imaging Project Management @Daiichi Sankyo, Inc.
Project Management
Salary đź’¸ unspecified
Remote Location
USA
Job Type full-time
Posted Mar 30, 2025
Apply for this position Unlock 54,667 Remote Jobs
️
đź“Ť Be aware of the location restriction for this remote position: USA
‼ Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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