Director, PV Quality & Compliance

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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.

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; thereby promoting inspection readiness and maintaining a robust global compliance program within the PSPV department. This position will lead PSPV’s preparation, delivery, and response to audits / inspections, support issue reporting and CAPA development, oversee and monitor internal and vendor quality and compliance, oversee and monitor SDEA compliance, lead the development and maintenance of the PSMF, and build a training model for PSPV and cross-functional teams.

This position will also support PV Operations leadership via operational activities including, but not limited to:

• Development of PV documentation (SOPs, WIs, SAE/pregnancy forms, ICFs)

• Protocol deviation, CAPA, and PV Training management

• Communication with internal and external shareholders

• 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 Standard Operating Procedures (SOPs) / Work Instructions (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 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, and functional goals.
• Regulatory & Safety Reporting:
  • Ensure PV system is set up for accurate…