Head of Clinical Operations

Key Responsibilities

• Oversee the day-to-day clinical operations team, including Clinical Operations Study Leads (COSLs), Clinical Research Associates (CRAs), and other operations staff.
• Develop and implement SOPs, work instructions, tools, templates, workflows, and study-level performance metrics to optimize operational efficiency and compliance.
• Strike new and manage existing business relationships with CROs, clinical sites, vendors, and consultants to ensure high-quality vendor performance and financial accountability.
• Collaborate with Medical, Clinical Science, Data Management, Quality Assurance, Regulatory, Clinical Supply, Regulatory and other departments to support clinical development programs.
• Perform as a key member of a product development team to provide timelines, budgets, feasibility, and product strategy.
• Support COSLs in study start-up, development of study budgets, plans, and timely and quality study execution with excellent vendor oversight.
• Monitor clinical trial progress, identify risks and mitigation strategies, and provide regular updates to leadership.
• Help strategize with study teams for rapid study start-up, site initiation, accruals to assigned product trials, and rapid database locks (60 days or less).
• Ensure compliance with ICH-GCP guidelines, FDA regulations, and other applicable global regulatory requirements.
• Lead and mentor team members, fostering a high-performance culture and supporting professional development.
• Help lead inspection readiness initiative and regulatory authority inspections/audits. Be a key member of the audit response team.

Requirements

• Bachelor's degree in a related field (Life Sciences, Nursing, etc.).
• Minimum of 12 years of clinical research experience, including 5+ years in a leadership or management role.
• Experience in early-phase oncology trials, and/or immunology and inflammation (I & I) trials, biomarker driven therapy, and small molecule drugs.
• Clinical operations lead of a minimum of 1 prior successful product approval and NDA submission with experience of a minimum of 1 accelerated approval pathway and compressed regulatory timelines.
• Experience in global clinical trials, early and late phase research.
• Strong understanding of clinical development processes, ICH-GCP, FDA, and international regulatory requirements.
• Proven track record of successfully managing global clinical trials across all phases.
• Excellent leadership, communication, and interpersonal skills.
• Ability to thrive in a fast-paced, dynamic, and collaborative environment.