Senior Director, Clinical Operations - Immunology & Inflammation (I&I)
Senior Director, Clinical Operations - Immunology & Inflammation (I&I)
Location: Remote (U.S.) San Francisco-based candidates strongly preferred
About the Company
This clinical‑stage biotech is building the next wave of therapies in Immunology & Inflammation (I&I), and the timing to join is exceptional. The company recently closed a $300M Series C, taking total capital to $700M+ and securing 36+ months of operating runway. The pipeline includes five programs across four I&I indications, designed to balance near-term proof-of-concept milestones with longer-term opportunities. Confidence in execution comes from leadership that has multiple prior drug approvals at small biotechs and has raised over $1B in previous ventures; the CEO has led two prior companies to acquisition. Its culture is collaborative, agile, and mission-focused, offering employees the chance to make a tangible impact on patients' lives while working alongside some of the brightest minds in the industry.
Role Overview
The Senior Director, Clinical Operations, will lead global operational strategy and delivery across the I&I portfolio. Reporting to the VP/Head of Clinical Operations, this leader will own end‑to‑end study execution (Phase 1-3), build and manage a high‑performing team, and ensure programs meet timeline, quality, budget, and compliance goals.
Key Responsibilities
- Strategic Leadership: Define and implement clinical operations strategies for multiple I&I programs.
- Trial Execution: Oversee all aspects of clinical trial delivery, including protocol development, site selection, enrollment, monitoring, and close-out.
- Vendor Oversight: Manage CROs and other external partners to ensure quality, compliance, and timely execution.
- Budget & Resource Management: Develop and manage clinical budgets and resource plans.
- Compliance & Quality: Ensure adherence to ICH/GCP, regulatory requirements, and internal SOPs.
- Cross-Functional Collaboration: Partner with Clinical Development, Regulatory, Biometrics, and Medical Affairs to achieve program objectives.
- Team Development: Recruit, mentor, and lead a high-performing Clinical Operations team.
Qualifications
- Experience: 15+ years in Clinical Operations with 8+ years leading global trials; track record delivering Phase 1-3 studies in biotech or pharma.
- Therapeutic Expertise: Demonstrated experience in I&I (e.g., dermatology, rheumatology, respiratory, or GI).
- Operational Excellence: Proven success with CRO oversight, complex protocol execution, multi‑country activation, enrollment leadership, and inspection readiness.
- Leadership: Ability to build, scale, and motivate high‑performing teams; strong communication and stakeholder management; thrives in a fast‑paced, growth‑stage environment.
- Technical Knowledge: Solid understanding of ICH/GCP, global regulatory expectations, risk‑based monitoring, and data integrity principles.
- Education: Bachelor's degree in Life Sciences required; advanced degree preferred.
What the Company Offers
- Opportunity to shape and scale Clinical Operations in a well‑funded, clinical‑stage environment with near‑term clinical catalysts.
- Collaborative culture that values clarity, accountability, and patient impact.
- Competitive compensation including base salary, annual bonus, long‑term equity, and comprehensive benefits.
- Hybrid work model with flexibility for the right senior‑level candidate.
FAQs
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