Director, PV Quality & Compliance

Summary

Title: Director, PV Quality & Compliance

Department: Patient Safety & PV

Date Posted: 12/7/2025

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.

Summit’s 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.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

• 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.
• 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 China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

The Associate Director of PV Quality and Compliance will report to the Senior Director, PV Operations and Compliance and is responsible for oversight of Patient Safety & PV (PSPV) quality, compliance, Pharmacovigilance System Master File (PSMF) development and maintenance, and SDEA management activities. This role promotes inspection readiness and maintains a robust global compliance program within the PSPV department. The position will lead PSPV’s preparation, delivery, and response to audits/inspections, support issue reporting and CAPA development, oversee internal and vendor quality and compliance, oversee SDEA compliance, develop and maintain the PSMF, and build a training model for PSPV and cross‑functional teams.

Key operational activities include:

• Development of PV documentation (SOPs, WIs, SAE/pregnancy forms, ICFs)
• Protocol deviation, CAPA, and PV Training management
• Communication with internal and external stakeholders
• Subject Matter Expert in audits and inspections with PV scope
• Support day‑to‑day PV Operational activities as needed

• Oversight and Leadership
  • Lead the development, review, and maintenance of SOPs / WIs for PSPV.
  • Ensure PV processes and systems comply with global regulatory guidelines, company policies, industry best practices, and SDEA standards.
  • Develop and implement a comprehensive quality assurance strategy aligned with PSPV functional goals; including the development, maintenance, and execution of the PSPV Audit Plan and audit program in collaboration with R&D Quality Assurance.
  • Prepare and present PV Compliance Reports to senior management, highlighting trends, issues, and opportunities for improvement.
  • Drive continuous improvement initiatives to enhance the efficiency and effectiveness of PSPV quality activities.
• Regulatory & Safety Reporting
  • Ensure PV system is set up for accurate reporting of adverse events and periodic reports in compliance with global regulatory requirements.
  • Monitor and analyze vendor and internal key performance indicators (KPIs) and key quality indicators (KQIs) to ensure effective PV processes and compliance.
  • Ensure compliance with all…