Summit Therapeutics, Inc.

Clinical Operations

• Lead and oversee global oncology study start-up activities from site selection through site activation
• Drive timely site activations across regions, regulatory readiness, contracts, budgets, and essential core documents
• Collaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with country regulatory and company standards
• Partner closely with Legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contracts; oversee the complex negotiation of clinical trial insurance certificates and country-specific mandates.
• Manage and develop a team of direct reports, providing active mentorship, performance management, and career development; extend mentorship to non-direct reports within the broader Clinical Operations department to harmonize start-up best practices.
• Build, optimize, and scale study start-up processes, SOPs, and "playbooks" suitable for a growing biotech; lead formal process improvement initiatives to reduce cycle times from site selection to activation.
• Drive the standardization of core study documents, including global Master Informed Consent Forms (ICF), Investigator Packages, and essential document checklists to ensure consistency and speed.
• Partner with Business Operations and IT to identify and implement technology solutions (e.g., SSU tracking modules, eTMF automation) to replace manual processes and improve data transparency.
• Partner closely with Clinical Operations, Clinical Development, Quality, Legal, and Finance
• Confidently present the budget to the Chief Accounting Officer and Head of Clinical Operations for approval, ensuring full knowledgeable of all details
• Partner with Finance team to provide study-wide site payment estimates and forecasts
• Provide regular updates to management on progress and key performance indicators related to trial agreements
• Establish and track start-up KPIs and metrics to improve predictability and cycle times
• Provide oversight and governance of CROs, FSP Providers and start-up vendors, including performance management and issue escalation

Senior Director, Clinical Operations – Study Start-Up

QA Engineer

• Support the development, implementation, and maintenance of GMP quality systems, including policies, procedures, and risk assessments in alignment with global health authority regulations (FDA, EMA, ICH, etc.)
• Assist in ensuring GMP compliance at Contract Manufacturing Organizations (CMOs) by providing sponsor oversight and supporting clinical and commercial manufacturing activities
• Participate in inspection readiness activities, including documentation preparation and coordination for internal audits and regulatory inspections
• Assist with investigations, root cause analysis, risk assessments, and corrective and preventive actions (CAPAs) to ensure timely resolution of quality-related issues
• Support internal QA batch review and release processes to ensure compliance with applicable regulations
• Review and help maintain controlled documents, including Standard Operating Procedures (SOPs), to align with regulatory requirements and industry best practices
• Collaborate with cross-functional teams to achieve quality and compliance objectives
• Assist in tracking and maintaining quality metrics and performance indicators
• Perform other duties as assigned to support Quality Assurance initiatives

Manager, Quality Assurance – GMP

• Oversee and manage the execution of one or more phase 1-3 clinical trials.
• Management of all clinical operations support vendors contracted for the assigned study(ies), including budgets and timelines oversight, performance management, risk management, and issue resolution
• Establish and coordinate all ongoing study management activities, including leading the cross-functional study team development of an overall study execution plan to deliver key study deliverables.
• Daily activities may include updating/reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, etc.), monitoring study status across internal functions and external vendors, anticipating and mitigating risks within the timeline, quality, and study budget
• Cultivate and maintain strong relationships with investigators and trial site administrators; Organize investigator meetings as needed; contributes to the development of abstracts, presentations, and manuscripts for studies
• Maintain oversight of clinical operations budget, including regular forecasting and internal reporting to management and finance; review vendor invoices against the scope of work and work completed to date; identify and communicate discrepancies
• Support the development of quality control processes and study plans to ensure that clinical activities are compliant with Good Clinical Practice and regulatory guidelines. Ensure execution of trials according to the study protocol and procedures, SOPs, ICH/GCP, FDA, EMEA, NICE, and other relevant policies and regulations.
• Support clinical and non-clinical supplies planning for trial execution.

Director, Clinical Operations

Research Analyst

• Support all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out.
• Collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director.
• Direct and complete communication between the project team and site personnel to ensure appropriate training, understanding of project requirements, and milestones.
• Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites.
• Initiate and build professional relationships with clinical site staff.
• Partner with the CRO to ensure robust ongoing data monitoring strategies.
• Creation and development of study trackers.
• Develop and provide clear, complete documentation of study-specific meetings and action items.
• Responsible for the development and management of clinical trial documents.
• Ensure compliance of clinical trials with national regulatory requirements and company SOPs.
• Provide close oversight on findings from monitoring reports and communicate updates as needed.

Clinical Research Associate

• Supports all aspects of Clinical Trial Management for complex, global studies
• Collaborates with functional team members, CROs, and vendors
• Directs and completes communication between the project team and site personnel
• Reviews, approves, and tracks vendor invoices and manages accruals and payment process for all assigned clinical trial vendors
• Initiates and builds professional relationships with clinical site staff
• Responsible for the development and management of clinical trial documents
• Provides close oversight on findings on the monitoring reports

• Support the development, implementation, and maintenance of GMP quality systems, including policies, procedures, and risk assessments in alignment with global health authority regulations (FDA, EMA, ICH, etc.)
• Assist in ensuring GMP compliance at Contract Manufacturing Organizations (CMOs) by providing sponsor oversight and supporting clinical and commercial manufacturing activities
• Participate in inspection readiness activities, including documentation preparation and coordination for internal audits and regulatory inspections
• Assist with investigations, root cause analysis, risk assessments, and corrective and preventive actions (CAPAs) to ensure timely resolution of quality-related issues
• Support internal QA batch review and release processes to ensure compliance with applicable regulations
• Review and help maintain controlled documents, including Standard Operating Procedures (SOPs), to align with regulatory requirements and industry best practices
• Collaborate with cross-functional teams to achieve quality and compliance objectives
• Assist in tracking and maintaining quality metrics and performance indicators
• Perform other duties as assigned to support Quality Assurance initiatives
• All other duties as assigned

• Oversee and manage the execution of one or more phase 1-3 clinical trials.
• Management of all clinical operations support vendors contracted for the assigned study(ies), including budgets and timelines oversight, performance management, risk management, and issue resolution.
• Establish and coordinate all ongoing study management activities, including leading the cross-functional study team development of an overall study execution plan to deliver key study deliverables.
• Daily activities may include updating/reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, etc.), monitoring study status across internal functions and external vendors, anticipating and mitigating risks within the timeline, quality, and study budget.
• Cultivate and maintain strong relationships with investigators and trial site administrators; Organize investigator meetings as needed; contributes to the development of abstracts, presentations, and manuscripts for studies.
• Maintain oversight of clinical operations budget, including regular forecasting and internal reporting to management and finance; review vendor invoices against the scope of work and work completed to date; identify and communicate discrepancies.
• Support the development of quality control processes and study plans to ensure that clinical activities are compliant with Good Clinical Practice and regulatory guidelines.
• Ensure execution of trials according to the study protocol and procedures, SOPs, ICH/GCP, FDA, EMEA, NICE, and other relevant policies and regulations.
• Support clinical and non-clinical supplies planning for trial execution.

Director

• Develop, execute and maintain high impact territory plans, including HCP and Investigator engagement plans in alignment with therapeutic area medical and scientific objectives with a focus on quality.
• Support clinical development and research initiatives across development at the request of R&D to include, but not limited to, site evaluation and identification, recruitment, investigator meetings, external expert identification, and involving experts to generate scientific data including investigator-sponsored trials.
• Identify, gain access to, and develop professional customer centric based relationships with external experts in Immuno-Oncology within assigned geography.
• Provide education relative to disease state, therapeutic landscape and Summit Therapeutics products across the product lifecycle to healthcare providers and researchers.
• Participate, monitor, and provide insights to Summit from relevant scientific meetings in relevant geography.
• Continuously maintain self-education on market issues/trends, product knowledge, and new therapeutic areas of interest as it pertains to specific business responsibilities, including creating awareness and relationships for Summit Therapeutics in the Medical community.
• Actively participate in relevant team meetings, organizational activities, and Country-driven medical affairs activities (e.g. advisory boards, masterclasses, roundtables).
• Create, maintain, and collaborate in relationships with Cross-Functional partnerships, as appropriate, to develop and execute Account plans designed to support and meet shared scientific or business objectives.
• All other duties as assigned.

Senior Director, Clinical Operations – Study Start-Up

Manager, Quality Assurance – GMP

Director, Clinical Operations

Clinical Research Associate

Clinical Research Associate

Manager, Quality Assurance – GMP

Manager, Quality Assurance – GMP

Director, Clinical Operations

Regional Medical Science Director