Director, Clinical Operations Analytics – Performance Excellence

🕒 October 13

🇺🇸 United States – Remote

💵 $190k - $237k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2003

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of innovative medicinal therapies aimed at improving quality of life for oncology patients. The company is particularly committed to addressing serious unmet medical needs through its lead investigational therapy, ivonescimab, a novel bispecific antibody designed to target both PD-1 and VEGF. Summit’s initiatives include ongoing Phase III clinical trials to evaluate ivonescimab's effectiveness in treating non-small cell lung cancer, highlighting their dedication to patient-centered care and technological advancement in the field of oncology.

📋 Description

• Develop and execute the Clinical Operations analytics roadmap, including AI, automation, predictive analytics, and advanced reporting priorities. • Establish portfolio performance measurement frameworks, KPIs, health metrics, scorecards, dashboards, and executive reporting. • Interpret portfolio trends, identify risks, and recommend actions to improve study execution. • Present actionable portfolio insights and strategic recommendations to leadership and executive teams. • Lead Clinical Operations data governance and operational data quality accountability. • Serve as the Veeva Vault Clinical subject matter expert, including CTMS, SSU, and Site Engagement capabilities. • Establish operational data definitions and standards across CTMS, SSU, eTMF, and imaging platforms. • Partner with CROs, IT, and external vendors on data transfers, analytics platforms, reporting tools, integrations, normalization, and data repositories. • Evaluate and implement AI-enabled analytics, predictive capabilities, and reporting automation. • Lead process and quality improvement initiatives using Lean, Six Sigma, or equivalent methodologies. • Drive standardized workflows, data governance practices, Veeva Vault Clinical improvements, change management, and training. • Build a data-driven culture and lead and develop a high-performing team of analytics professionals and business analysts. • Influence cross-functional stakeholders and translate business questions into analytics requirements.

🎯 Requirements

• Bachelor's degree in Life Sciences, Data Analytics, Business, Information Systems, Public Health, or related discipline. • 12+ years of experience in Clinical Operations, Clinical Systems, Clinical Analytics, RBM, or related functions. • Minimum 5 years of leadership experience managing teams and complex cross-functional initiatives. • Deep understanding of clinical trial execution processes and operational metrics. • Demonstrated experience with Clinical Operations technology platforms and reporting. • Experience building executive dashboards and performance management frameworks. • Strong knowledge of ICH-GCP, regulatory requirements, and inspection readiness expectations. • Proven ability to lead organizational change initiatives.

🏖️ Benefits

• Potential bonus • Stock • Benefits • Other applicable variable compensation

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