The posting
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
- HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
- HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
- HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
- HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role:
The Director, Clinical Operations Analytics & Performance Excellence leads the analytics strategy for the global clinical trial portfolio and serves as the business owner for operational performance analytics, metrics, portfolio reporting, Clinical Operations data governance, and Veeva Vault Clinical capabilities. This role functions as the Clinical Operations subject matter expert (SME) for the Veeva Vault Clinical platform, ensuring alignment between business processes, system capabilities, data standards, and operational reporting requirements. The Director translates operational data into actionable insights to improve study execution, portfolio predictability, resource planning, site performance, inspection readiness, and risk-based decision-making.
This leader transforms operational data into strategic insights that improve study execution, portfolio predictability, resource planning, site performance, inspection readiness, and risk-based decision-making across the organization. Serving as the business lead and SME for Veeva Vault Clinical, the Director drives platform optimization, user adoption, process standardization, governance, and integration with the broader clinical technology ecosystem. Partnering with Clinical Operations, IT, Data Management, Biostatistics, RBM, Study Start-Up, Clinical Trial Management, and executive leadership, the Director develops scalable analytics capabilities and operational systems that enable data-driven study oversight and portfolio management. The role advances standardized data practices and leverages AI, automation, predictive analytics, and modern clinical technology platforms to support portfolio growth, operational excellence, and continuous process improvement.
Role and Responsibilities:
Clinical Operations Analytics Strategy
- Develop and execute the Clinical Operations analytics roadmap aligned with organizational objectives, including priorities for AI, automation, predictive analytics, and advanced reporting.
- Establish the portfolio performance measurement framework, defining leading and lagging indicators to assess study performance, operational health, quality, and execution risk.
Performance Excellence & Portfolio Performance Analytics
- Translate the performance measurement framework into standardized Clinical Operations KPIs, portfolio health metrics, and reporting across clinical programs.
- Establish operational scorecards for studies, sites, countries, vendors, and functions to monitor performance and quality.
- Develop and maintain portfolio dashboards and executive reporting that provide visibility into Clinical Operations performance.
- Partner with Clinical Operations leaders to interpret portfolio trends, identify risks, and recommend actions to improve study execution.
- Present actionable portfolio insights and strategic recommendations to leadership and executive teams to support performance reviews and data-driven decision-making.
Clinical Operations Data Governance & Data Quality
- Serve as the functional leader for Clinical Operations data governance, defining ownership and accountability for operational data quality.
- Serve as the SME in data and processes in Veeva Vault Clinical, including processes within CTMS, SSU and Site Engagement capabilities.
- Establish consistent data definitions and standards for operational data entry, maintenance, and quality across programs and key systems, including CTMS, SSU, eTMF, and imaging platforms.
- Partner with CROs to align operational data transfers with Clinical Operations analytics requirements and governance standards.
- Establish mechanisms to monitor operational data accuracy, completeness, and consistency, and coordinate issue resolution with accountable data owners.
Clinical Analytics Technology Enablement
- Partner with IT and external vendors to optimize analytics platforms, reporting tools, data integrations, and data normalization within the enterprise data lake.
- Define business requirements for analytics capabilities and operational technologies.
- Support implementation and enhancement of operational data repositories and visualization platforms that scale with portfolio growth.
- Evaluate and implement AI-enabled analytics, predictive capabilities, and reporting automation in partnership with IT to improve operational insights and reduce manual reporting effort.
Process Excellence & Continuous Improvement
- Use analytics findings to identify and prioritize process and quality improvement opportunities across the clinical portfolio.
- Lead improvement initiatives that address operational inefficiencies and underlying workflow causes of data quality and reporting issues.
- Apply Lean, Six Sigma, or equivalent methodologies to optimize Clinical Operations processes.
- Establish performance benchmarks and share best practices across studies to guide and assess improvement efforts.
- Drive adoption of standardized workflows and data governance practices through change management and training.
- Drive improvements in Veeva Vault Clinical to support Clinical Trial process adoption and improved data governance across the clinical portfolio
Leadership & Cross-Functional Collaboration
- Build a data-driven culture of accountability, transparency, and continuous improvement across Clinical Operations.
- Lead and develop a high-performing team of analytics professionals and business analysts.
- Influence cross-functional stakeholders without direct authority to align priorities and advance analytics initiatives.
- Partner with Clinical Operations leadership to translate business questions into meaningful analytics requirements.
Required Experience, Education and Specialized Knowledge and Skills:
- 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.
Preferred
- Advanced degree (MS, MPH, MBA, PharmD, or equivalent).
- Experience leading Clinical Operations analytics organizations.
- Experience with Power BI, Tableau, Spotfire, Smartsheet, or similar analytics platforms.
- Experience with AI-enabled analytics, predictive modeling, or operational intelligence solutions.
- Lean Six Sigma certification or equivalent process excellence training.
This is the pay for this position
Pay Transparency
$190,000—$237,000 USD
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at [email protected] to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
