Associate Director, Clinical Science

Added
16 minutes ago
Type
Full time
Salary
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Related skills

gcp project management regulatory affairs data review clinical research

πŸ“‹ Description

  • Develop rigorous study concepts, including study design, schedule of assessments
  • Integrate stakeholder feedback and direct protocol authoring; use data to respond to health
  • Support regulatory interactions and author clinical sections for regulatory correspondence and
  • Provide protocol training and contribute directly to Case Report Form (CRF) design
  • Ensure study manuals align with protocol and engage investigators directly in study design
  • Actively participate in pre-site selection discussions, site initiation visits, and investigator

🎯 Requirements

  • Ph.D., RN, MS, or B.S. in scientific field; advanced degree preferred (MS, PharmD, MD, or PhD)
  • 8-10+ years of clinical research experience, including 3-5+ years in management role
  • Experience in oncology and early cancer detection is highly preferred
  • Experience with project management, clinical research execution, and rigorous scientific writing
  • Experience with In Vitro Diagnostics (IVD) is a plus
  • Deep knowledge of regulatory standards and GCP required

🎁 Benefits

  • Comprehensive medical, dental, vision, life and disability plans
  • Free Natera testing for employees and immediate family
  • Fertility care benefits
  • Pregnancy and baby bonding leave
  • 401k benefits
  • Commuter benefits
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