Director, Clinical Scientist (Respiratory indications)

Added
11 days ago
Type
Full time
Salary
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Related skills

gcp biostatistics regulatory submissions clinical development protocol design

๐Ÿ“‹ Description

  • Lead clinical science for respiratory studies (asthma/COPD)
  • Oversee day-to-day study execution per protocol and timelines
  • Design trial protocols and key documents (SP, CSR, CRF, SAP)
  • Contribute to regulatory documents (IBs, CSRs, briefing books)
  • Monitor safety and data quality with cross-functional teams
  • Manage site selection, initiation, and investigator inquiries

๐ŸŽฏ Requirements

  • Advanced degree (PhD, PharmD, MD, MS, PMP) and 9+ years in clinical development, including late-stage respiratory
  • Strong knowledge of clinical research methods, regulatory guidelines, and GCP
  • Demonstrated ability to lead clinical science strategy and execution in late-stage trials
  • Excellent analytical, communication, and cross-functional collaboration skills
  • Prior experience authoring clinical protocols, CSRs, and regulatory documents

๐ŸŽ Benefits

  • Remote work option with occasional travel to HQ
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