Jobs at Summit Therapeutics, Inc.

Supports and optimizes corporate G&A applications for Finance, HR, and Legal, including NetSuite, Coupa, Agiloft, HRIS, and CLM systems. Translates business needs into technical requirements, manages application health, builds reports and dashboards, supports SOX ITGC controls and audits, coordinates testing and implementations, and develops training and documentation.

Provides GMP quality oversight across biologics development and manufacturing, including CMOs, CTLs, process validation, technology transfer, change controls, comparability, quality systems, inspections, investigations, CAPA, risk management, and CMC regulatory submissions. Partners with MSAT and Technical Operations, leads quality improvement initiatives, manages product quality reviews and metrics, and ensures compliance with global GMP requirements throughout the product lifecycle.

Manages pharmaceutical transparency compliance, including Sunshine Act reporting, transfer-of-value data reconciliation, HCP/HCO dispute resolution, audits, risk assessments, investigations, training, and policy development. Partners with Legal, Medical Affairs, Sales, HR, Internal Audit, and other stakeholders to maintain accurate reporting, strengthen compliance controls, address issues, and support annual certification and government requirements.

Lead regional clinical operations for Phase I-III oncology trials across the Middle East. Drive country start-up strategy, site activation, stakeholder engagement, regulatory approvals, feasibility, enrollment, timelines, budget, quality, and inspection readiness. Serve as senior escalation point and represent the company externally to investigators, regulators, and institutions.

Provides strategic and operational leadership for complex global regulatory programs and submissions across oncology products. Coordinates Regulatory Affairs, Research, Development, Manufacturing, Medical Writing, and executive stakeholders; manages milestones, risks, timelines, governance, health-authority interactions, and regulatory filing deliverables. The role also advances regulatory program-management processes, improves portfolio visibility, supports operating-model development, and mentors program managers.

Oversee global pharmacovigilance operations, including ICSR processing, vendor governance, safety database management, regulatory compliance, reconciliation, aggregate reporting, audits, inspections, CAPAs, SOPs, safety agreements, and risk-management deliverables. Partner with CROs and cross-functional teams to maintain inspection readiness, meet reporting timelines, manage PV systems, and support clinical and post-market safety programs.

Directs commercial excellence infrastructure for a biopharmaceutical oncology launch, including incentive compensation, territory alignment, CRM administration, targeting and segmentation, KPI governance, roster management, sales crediting, and field reporting. Partners with Marketing, Market Access, Medical Affairs, Finance, Compliance, and Field Excellence to ensure compliant, accurate, and scalable commercial operations.

Develops clinical study reports, dashboards, visualizations, data-monitoring listings, edit checks, ETL pipelines, and reusable R packages for clinical trial data workflows. Collaborates with Data Management, Clinical Operations, and vendors to identify site risks, improve data quality, automate processes, and maintain audit-ready documentation. Requires pharmaceutical or biotech programming experience, proficiency in R or Python, clinical trial process knowledge, and strong cross-functional communication skills.

The Director of FP&A Commercial leads annual planning, quarterly forecasting, and long-range planning for Commercial functions. Responsibilities include financial modeling, revenue and pricing analysis, pre-launch NPV modeling, vendor contract review, close support, budget-to-actual analysis, internal controls, and identifying financial risks and opportunities. The role partners across Finance, Accounting, and Commercial teams to improve processes and support strategic business decisions.

Leads global Phase II/III oncology clinical trials from startup through closeout, overseeing sites, CROs, enrollment, monitoring, data quality, TMF completeness, risk management, regulatory compliance, audits, and inspection readiness. Reviews study plans and clinical data, resolves operational risks, mentors clinical operations staff, and represents Clinical Operations on cross-functional governance teams.

Manages global Phase II/III clinical trials from site selection and study startup through closeout. Oversees CROs, site performance, enrollment, monitoring, clinical data quality, risk-based quality management, TMF completeness, regulatory compliance, and inspection readiness. Coordinates study plans and deliverables, resolves operational issues, reviews monitoring reports and data listings, and mentors clinical operations staff. Global oncology experience is preferred, with international travel of up to 20%.

Provides operational leadership for global Phase II/III oncology clinical trials, overseeing clinical operations teams, CROs, vendors, budgets, timelines, quality, and inspection readiness. Leads study planning and execution, risk mitigation, TMF oversight, regulatory inspection preparation, outsourcing strategy, and cross-functional collaboration. Manages and mentors CTMs, CRAs, and other clinical operations staff while driving process improvement and compliance with GCP, ICH guidelines, and applicable regulations.

Leads pharmacovigilance and medical safety activities for investigational and marketed oncology products. Responsibilities include reviewing individual case safety reports, evaluating adverse events and signals, supporting expedited reporting and unblinding, preparing aggregate safety documents, maintaining reference safety information, coordinating with safety committees and vendors, ensuring regulatory inspection readiness, improving medical safety processes, and mentoring medical safety reviewers.

Leads U.S. regional marketing strategy and commercialization for an oncology biopharmaceutical portfolio. Builds and manages a regional marketing organization, establishes customer and thought-leader engagement strategies, integrates congress and speaker programs, synthesizes market insights, and partners across Marketing, Sales, Medical Affairs, Market Access, Legal, and Compliance. Ensures compliant execution, organizational development, strategic alignment, and effective translation of national brand strategies into regional initiatives.

Leads clinical quality assurance activities across clinical and preclinical programs. Responsibilities include managing clinical site and vendor audits, overseeing quality plans, CAPAs, investigations, inspection readiness, regulatory compliance, vendor issues, and internal audits. The role advises cross-functional teams on GCP, GLP, pharmacovigilance, and global health authority requirements while supporting continuous process improvement and quality risk management.

Analyzes internal and syndicated pharmaceutical commercial data to identify performance drivers, patient journey trends, market opportunities, access friction, and competitive shifts. Builds dashboards, supports segmentation and forecasting, investigates data quality issues, and translates findings into actionable recommendations for Sales, Marketing, Market Access, and Commercial Operations. The role requires hands-on experience with oncology commercial analytics, pharmaceutical secondary data, buy-and-bill products, claims, patient-level datasets, SQL, and business intelligence tools.

The Chief Commercial Officer will lead Summit’s global commercial strategy and commercialization of ivonescimab. Responsibilities include market access, pricing, reimbursement, health economics, sales and marketing leadership, product launch execution, strategic partnerships, stakeholder engagement, budgeting, competitive analysis, and regulatory compliance. The role requires extensive pharmaceutical or biotechnology commercial leadership experience, oncology launch expertise, and a proven record of global product commercialization.

Leads global clinical trial site agreement development, budget strategy, contract and budget negotiations, payment forecasting, and site activation support. Partners with Legal, Finance, Clinical Operations, CROs, FSPs, and clinical sites to ensure compliant, cost-effective agreements and timely execution. Oversees vendors, resolves contract and payment issues, reports performance metrics, develops outsourcing strategies, and improves departmental processes across large, multi-site oncology trials.

Provides strategic and operational leadership across pharmaceutical development programs and portfolios. Oversees program strategy, prioritization, governance, timelines, risk management, scenario planning, executive reporting, and cross-functional execution across Research, Development, Regulatory, Manufacturing, and Corporate Strategy. Leads global late-stage oncology programs, supports regulatory approval, manages external partnerships, mentors program management leaders, and drives continuous improvement of program management processes and operating models.

Leads marketing operations for a biopharmaceutical commercial organization, including promotional review committee workflows, content lifecycle management, speaker programs, events, vendors, budgets, marketing technology, fulfillment, and performance reporting. Partners with Marketing, Medical, Legal, Regulatory, Compliance, Commercial, agencies, and Finance to build scalable, compliant processes and support omnichannel initiatives, market access materials, product launches, and field execution.