Jobs at Summit Therapeutics, Inc.

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.

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 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.

The Director, Value Outcomes Liaison engages payers, health systems, P&T committees, pathway organizations, and policymakers to communicate clinical, humanistic, and economic evidence for ivonescimab. The role develops stakeholder relationships, supports formulary and pathway inclusion, collaborates with HEOR, medical affairs, and market access teams, communicates evidence gaps, and informs engagement strategies. Extensive healthcare and pharmaceutical experience, oncology knowledge, field-based market access expertise, and frequent travel are required.

Leads value-outcomes engagement with U.S. payers, health systems, pathway organizations, P&T committees, and policymakers. Provides objective clinical, economic, and humanistic information on ivonescimab; supports formulary, pathway, and treatment-order-set decisions; collaborates with medical affairs, HEOR, and market access teams; develops stakeholder relationships, communicates evidence, identifies evidence gaps, and informs access strategy. Requires extensive healthcare and pharmaceutical experience, oncology knowledge, field-based market access expertise, and up to 75% travel.

Lead global regulatory strategy for oncology programs from IND/CTA through BLA/MAA and post‑marketing. Provide cross‑functional regulatory leadership, lead due diligence for partnerships, mentor RA staff, drive labeling and risk‑mitigation strategy, liaise with global authorities, and support product launch activities with minimal oversight.

Lead global regulatory strategy and execution for oncology products, securing IND/CTA approvals and supporting BLA/MAA submissions. Provide regulatory leadership across regions, advise cross-functional teams on regulatory requirements, mentor RA staff, manage labeling activities, and interface with major regulatory authorities to ensure program success.

The Sr. Commercial Attorney will support the launch of Ivonescimab by drafting and negotiating commercial agreements, ensuring compliance with regulations, and advising on market strategies.