Sr. Director, Clinical Operations (Waltham)

Senior Director, Clinical Operations

Our Waltham based client is seeking a Senior Director, Clinical Operations to lead the planning, execution, and delivery of global clinical programs across Phase I–III. This role oversees all aspects of clinical trial operations, ensuring timelines, budgets, quality standards, and regulatory requirements are consistently met. The Senior Director will build and lead a high‑performing Clinical Operations team and collaborate closely with Clinical Development, Regulatory, Data Sciences, Quality, CMC, and external partners to ensure operational readiness and successful trial execution across multiple regions.

Key Responsibilities

• Provide strategic leadership for US Clinical Operations and guide execution of global clinical studies.
• Build, mentor, and manage a high‑performing clinical operations team.
• Lead end‑to‑end trial oversight, including start‑up, site and vendor selection, monitoring, data quality, and close‑out.
• Oversee CROs and key vendors to ensure quality, performance, and contract adherence.
• Develop operational plans, manage budgets and timelines, and proactively mitigate risks.
• Ensure TMF completeness, inspection readiness, and compliance with ICH‑GCP and global regulatory standards.
• Partner cross‑functionally to support protocol development, biomarker integration, forecasting, and governance reporting.
• Coordinate execution of multinational studies across US and global regions.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• 12+ years of clinical operations experience, including 7+ years leading global Phase I–III trials on the sponsor side.
• Strong experience with CRO oversight, international sites, and multi‑regional studies.
• Deep understanding of GCP, global regulatory frameworks, and clinical development processes.
• Experience in neuroscience, neuroinflammation, or rare disease preferred.
• Proven ability to lead and develop high‑performing teams.
• Strong operational planning, project management, and problem‑solving skills.
• Excellent communication and cross‑functional leadership abilities.
• Demonstrated success managing complex timelines, budgets, and operational risk in a dynamic environment.

About Stratacuity:

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