Director, Clinical Scientist (Respiratory indications)

Added
6 hours ago
Type
Full time
Salary
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Related skills

gcp biostatistics late_stage_trials clinical_study_plans

๐Ÿ“‹ Description

  • Serve as clinical science lead for respiratory studies (asthma and/or COPD).
  • Support day-to-day study execution, ensuring protocol and regulatory alignment.
  • Lead late-stage protocol design and regulatory docs (IBs, CSRs, briefing books).
  • Participate in medical monitoring to ensure data quality and participant safety.
  • Support site selection, initiation, and investigator engagement.
  • Track study progress and identify risks to timelines or data integrity; coordinate with CROs and vendors.

๐ŸŽฏ Requirements

  • Advanced degree (PhD/MD/PharmD/MS/PMP) with 9+ years in clinical development, incl. late-stage respiratory studies.
  • Strong knowledge of clinical research methods, regulatory guidelines, and GCP.
  • Proven ability to lead clinical science strategy and execution in late-stage trials.
  • Excellent analytical, communication, and cross-functional collaboration skills.
  • Experience authoring clinical protocols, CSRs, and regulatory documents.
  • Nice to Have: small molecule and biologic modalities; AI/ML driven drug discovery platforms; BLA/MAA submissions.

๐ŸŽ Benefits

  • Annual bonus, equity compensation, and a competitive benefits package.
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