The role
Navigator Medicines is building an immunology-first biotech focused on bispecific drug discovery for immunology and inflammatory diseases. As
Director of Clinical Operations, you will lead the planning and execution of our clinical development programs. This role will oversee outsourced Phase 1–3 clinical trials and ensure studies are delivered on time, within budget, and in full compliance with global regulatory and quality standards. This is a
hands-on leadership role in a small, growing biotech company. You will have high visibility, broad ownership, and the opportunity to directly shape how clinical operations are built and scaled at Navigator Medicines. You will work cross-functionally with internal teams and external partners to turn clinical strategy into operational excellence.
The problems you'll work on
As Director of Clinical Operations, you will tackle complex, high-impact challenges, including:
- Translating clinical development strategy into executable, efficient clinical trial plans
- Managing and optimizing CRO and vendor performance across timelines, quality, and cost
- Navigating operational risks in early- to late-stage clinical programs and proactively mitigating them
- Ensuring inspection readiness while operating in a lean, fast-moving biotech environment
- Building scalable processes and infrastructure that support current trials and future pipeline growth
What you'll learn
At Navigator Medicines, you will:
- Gain deep exposure to clinical decision-making in a small biotech setting, where your input directly influences outcomes
- Develop and refine scalable clinical operations frameworks from the ground up
- Expand your leadership impact by working closely with executive leadership and cross-functional teams
- Strengthen your expertise across the full clinical lifecycle, from early development through late-stage execution
How we work
- Programs run in a matrixed model, requiring strong collaboration across functions
- External partners matter: CROs, academics, and advisors are treated as extensions of the team, not vendors
- Strategy is debated openly, decisions are owned, and communication with senior leaders and advisors is direct and data-driven
What You Bring
- Bachelor's degree in life sciences or a related field
- 10+ years of clinical operations experience in biotech, pharma, and/or CRO environments
- Proven experience managing outsourced Phase 1–3 clinical trials
- Strong CRO and vendor management experience, including budget oversight
- Deep understanding of global clinical operations, GCP, and regulatory requirements
- Excellent communication, organizational, and problem-solving skills
- Comfort operating in a small or emerging biotech environment with high accountability
About Navigator Medicines
Navigator Medicines is a clinical-stage biopharmaceutical company dedicated to advancing biologics for targeted immune regulation and restoration. Founded in 2024 as a subsidiary of Sera Medicines with $100M Series A financing co-led by RA Capital Management and Forbion, the company focuses on developing innovative therapies for complex autoimmune diseases. Navigator Medicines is committed to improving the lives of patients with heterogeneous conditions through cutting-edge science and groundbreaking advancements in immune therapeutics.
Legal & Equal Opportunity Notice
Navigator Medicines is an equal opportunity employer and provides reasonable accommodations as required by Massachusetts and California law.
