Teams 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.

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.