Director, Clinical Operations

Navigator Medicines, Inc.
Boston, MA

Overview

Navigator Medicines is a clinical stage biotech company pioneering a portfolio of best-in-class treatments for inflammatory and autoimmune diseases, focusing on OX40L combination approaches. As the Director, Clinical Operations, you will lead the planning and execution of outsourced clinical trials, ensuring studies are delivered on time, within budget, and in compliance with global regulatory standards. This is a hands-on leadership role in a small biotech environment, with high visibility and cross-functional impact.

Key Responsibilities

  • Lead end-to-end clinical operations for Phase 1–3 trials
  • Manage CROs and clinical vendors, including performance, timelines, and budgets
  • Oversee study start-up, execution, enrollment, and close-out
  • Partner cross-functionally with Clinical Development, Regulatory, Biostatistics, Clinical Supply, and Quality
  • Ensure compliance with GCP, ICH, and applicable global regulations
  • Identify and mitigate operational risks; maintain inspection readiness
  • Contribute to building scalable clinical operations processes and SOPs

Qualifications

  • Bachelor's degree in life sciences or related field (advanced degree preferred)
  • 10+ years of clinical operations experience in biotech, pharma, or CRO environments
  • Proven experience managing outsourced Phase 1–3 clinical trials
  • Strong CRO/vendor management and budget oversight experience
  • Excellent communication, organizational, and problem-solving skills
  • Experience in a small or emerging biotech preferred

Why Join Us

  • High-impact role at a critical stage of company growth
  • Broad ownership and visibility across clinical programs
  • Collaborative, mission-driven biotech environment
Posted 2026-01-15

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