Clinical Imaging Director

Role Summary

Clinical Imaging Director

Responsibilities

• Expand Amgen‚Äôs end to end imaging process to all non-oncology TAs and integrate into wider clinical development procedures. Initial focus would be on obesity, inflammation and rare diseases.
• Representing clinical imaging on process improvement initiatives
• Standardize internal document templates and imaging vendor documentation (Charter, site manuals etc.) for common imaging readouts. Establish new procedures and documentations for novel or updated imaging procedures/criteria.
• Serve as a SME while supporting strategic sourcing and vendor management teams in vendor capability/quality evaluations.
• Develop training materials for imaging methods and endpoints to educate team members on expected/appropriate imaging strategies in clinical trials.
• Work closely with precision medicine, statistics, clinical development, regulatory and clinical operation leads to formulate appropriate imaging biomarker strategies
• Lead, design and implement multi-modality imaging measures as endpoints for clinical studies in a variety of TAs.
• Contribute to clinical biomarkers and diagnostics strategy by evaluating novel imaging modalities, novel image analysis tools and artificial intelligence tools.

Qualifications

• Basic Qualifications: Doctorate degree PhD OR PharmD OR MD and 5 years of biomedical or imaging-related field experience; OR Master‚Äôs degree and 8 years; OR Bachelor‚Äôs degree and 10 years.
• Preferred Qualifications:
  • An advanced degree with 7+ years of experience in clinical imaging research within a pharmaceutical company.
  • Proven track record of leading and managing clinical trials with cross-functional workflows.
  • Leadership experience in utilizing molecular imaging as a quantitative biomarker in clinical trials.
  • Experience with clinical MR imaging in evaluation of endpoints and investigation of adverse events is preferred.
  • Experience in imaging for obesity and rare diseases is preferred.