Teams at Summit Therapeutics, Inc.

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.

Leads global regulatory affairs activities for oncology clinical studies and ivonescimab development. Responsibilities include regulatory strategy, CTA and IND submissions, BLA/MAA filing support, FDA and health authority interactions, submission tracking, regulatory dossier management, labeling oversight, query responses, and cross-functional guidance. The role requires pharmaceutical regulatory experience, knowledge of US and international requirements, and expertise working with clinical studies, CROs, and regulatory agencies.