Job Description
📋 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. 🎯 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. 🎁 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
