Associate Director, Risk Based Quality Management Lead

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. Summits 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.

Summits team is inspired to touch and help change lives through Summits 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 Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland.

OverviewofRole:

TheAssociate Director Risk-Based Quality Management (RBQM Lead) is accountable for the operational execution of RBQM activities across assigned clinical studies. Serving as the primary RBQM subject matter expert within study teams this role implements andmaintainsstudy-level risk management centralized monitoring Key Risk Indicators (KRIs) Quality Tolerance Limits (QTLs) targeted monitoring strategies and risk review processes.

Working closely with Clinical Operations Clinical Science Data Management Biostatistics Medical Monitoring and CRO partners the RBQM Lead proactivelyidentifies evaluates escalates andmitigates risksthroughout the clinical trial lifecycle to support participant safety data reliability and regulatory compliance.

Role andResponsibilities:

Study-Level RBQM Execution

• Serve as the RBQM Lead and core study team member from protocol development through study closeout

• Lead RBQM planning execution and ongoing risk oversightthroughout study conduct.

• Develop andmaintainstudy-specific RBQM Plans and Critical-to-Quality (CtQ) factors ensuring alignment with protocolobjectivesandidentifiedstudy risks.

Risk Assessment & Risk Management

• Facilitate cross-functional risk identification and assessment workshops and lead creation and maintenance of studyRisk Assessment and Categorization Tools (RACTs).

• Document score track and periodically reassess risksidentifyingnew or emerging risks from study performance data and operational signals.

• Collaborate with study teams to implement risk mitigation strategiesand actionsmonitortheir effectiveness and recommendadditionalinterventions when needed.
  

Key Risk Indicator (KRI) Management

• Develop andmaintainstudy-specific KRIs linked toidentifiedrisks andCtQfactors including thresholds triggers and escalation pathways.

• Review and interpret KRI outputs and investigate threshold breaches and root causes.

• Facilitatestudy-teamRBQM reviewsand track KRI trends actions and mitigation outcomes.

Quality Tolerance Limit (QTL) Oversight

• Collaborate with study teams toestablishprotocol-specific QTLs

• MonitorQTLperformance throughout study conduct.

• Investigate QTL excursions and assess potential impact on participant safety and data integrity.

• Coordinate documentation of investigations assessments and corrective actions.

• Present QTL findings during study governance reviews.

Central Monitoring:

• Lead the implementation of centralized monitoring strategies across multiple clinical trials

• Monitor and review clinical trial data across sites to ensure accuracy completeness and

consistency with study protocols.

• Conduct routine centralized monitoring reviews through performing real-time data surveillance toidentifyoutliers trends and potential issues that couldimpactdata integrity.

• Analyze data visualizations listings dashboards and statistical outputs.

• Identifyunusual data patterns quality concerns and site-specific risks.

• Evaluate trends across subjects sites countries and regions.

• Assesseffectivenessof ongoing monitoring activities.

• Generate risk summaries and recommendations for study teams.

• Escalate significant findings requiringadditionaloversight.

• Conduct risk-based monitoring activities such as assessing site performance patient safety

data andidentifyingsites at risk of data discrepancies or protocol violations.

• Utilize central monitoring tools and platforms (e.g. RBQM EDC CTMS) to track study progress and ensure data consistency.

• Support data query resolution by coordinating with site and CRO teams and ensuringtimely

data corrections.

Study Risk Review Meetings

• Lead recurring study risk review meetings to update the RACT and risk registers andfacilitatecross-functionalrisk-managementdecisions.

• Prepare dashboards and study risk summaries and present significant risk signals KRI trends QTL status and mitigation activities.

• Track decisions and action items and ensuretimelyfollow-up.
  

Site Risk Surveillance

• Review site-level risk profiles and identify high-risk sites requiring additional oversight.

• Partner with Clinical Operations CRO teams CRAs Data Management Medical Monitoring and other stakeholders to develop and implement site-specific action plans.

• Monitor the effectiveness of interventions at high-risk sites and escalate persistent quality concerns.
  

Issue Management & CAPA Support

• Support investigations of significant quality events and compliance issues including root cause analyses.

• Contribute tothe definition of corrective and preventive actions (CAPAs)and quality improvement plans andmonitorthe effectiveness ofproposed actions throughout the conduct of the study.

Inspection Readiness

• Maintain inspection-ready documentation of risk assessments KRI and QTL reviews centralized monitoring activities findings corrective actions and recommendations.

• Support sponsor audits regulatory inspections and quality-control checks including preparation of RBQM-related responses and data-review reports.

• Prepare monitoring reports summarizing findings trends and recommendations forimprovementsto the study team in support of the preparation for internal and regulatory audits

• Ensure RBQM activitiescomply withGCP ICH guidelines FDA regulations and other applicable regulatory requirements.

• Participate in internal quality assurance activities and continuous improvement initiatives.

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree or equivalent in life science nursing pharmacy medical laboratory technology or other health/medical-related areas preferred.

• 10 years of clinical operations experience insponsorpharmaceutical or biotechnology organizations.

• 7 years of direct RBQM centralized monitoring risk-based monitoring clinical quality or study management experience.

• Experience supporting global Phase II and/or Phase III clinical trials.

• Experience conducting risk assessments; developing and managing KRIs and QTLs; andfacilitatingrisk review meetings.

• Demonstrated ability to interpret complex scientific clinical and operational data toidentifyquality and compliance risks and support centralized trial monitoring.

• Experience working with CROs RBQMtechnologyand clinical analytics platforms.

• Proven ability to oversee large complex studies managed in-house and through CRO partners.

• Demonstrated sound judgment and problem-solving ability related to regulatory requirements external partners timelines and complex clinical programs.

• Excellent planning communication negotiation and organizational skills.

• Strong knowledge of the drug development process ICH guidelines and GCP with a deep understanding of clinical trial execution and the ability to apply this knowledge to complex global studies.

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 Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics 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.