Sr/Exec Director Clinical Development

Added
1 hour ago
Type
Full time
Salary
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Related skills

gcp sap cdp protocols nda

๐Ÿ“‹ Description

  • Lead late-stage studies to move programs through pivotal trials and regulatory submissions.
  • Develop and manage the Clinical Development Plan (CDP) for timely trial execution.
  • Prepare key documents (INDs, Protocols, IBs, CRFs, SAPs) and oversee data review.
  • Represent Erasca at scientific meetings; coordinate with Health Authorities and IRBs.
  • Build relationships with internal teams, investigators, regulators, and stakeholders.
  • Interpret clinical data and provide strategic insights to guide development.
  • Manage development timelines and resources to hit milestones; ensure GCP and safety compliance.

๐ŸŽฏ Requirements

  • Undergraduate degree; PhD/PharmD or health-science advanced degree preferred.
  • 10+ years biotech/pharma clinical scientist or related development with late-stage focus.
  • Extensive oncology trials experience and late-stage development.
  • Experience leading regulatory submissions (NDA, PIP/PSP, label negotiation, Breakthrough, Accelerated) preferred.
  • Experience in dynamic startup/small company environment; able to work independently.
  • Strong strategic planning, cross-functional collaboration, data interpretation; excellent communication.

๐ŸŽ Benefits

  • Paid time off, holidays and sick leave
  • Medical, dental and vision plans
  • Short- and long-term disability; life/AD&D
  • FSAs/HSAs and commuter benefits
  • 401(k) with Erasca contribution; employee stock purchase plan
  • Employee assistance program
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