Manager, Pharmacovigilance Operations

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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.

• 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 Manager, Pharmacovigilance (PV) Operations will report to the Associate or Senior Director, Pharmacovigilance Operations. The Manager PV Operations will support the PV team through study management for PV Operations, including study start‑up, maintenance, and closure; vendor oversight of ICSR case management, submissions, and archival; SAE Reconciliation; aggregate report submissions; cross‑functional collaboration; and business partner management (if applicable). This position will also support PV Operations leadership via operational activities including, but not limited to:

• Support the development of PV documentation (SOPs, WIs, SAE/pregnancy forms, ICFs)
• Support the development of SMP (safety management plan)
• Assist in tracking and managing Protocol deviation, CAPA, and PV Training management
• Support Safety Science on signal detection, risk management, and literature search activities
• Communication with internal and external shareholders
• Support audits and inspections

• Study Management
  • Study start‑up
    • Develop/oversee SAE / Pregnancy Reporting forms, processes, and/or Safety Management Plan.
    • Support development of Investigator Meeting (IM) and/or Site Initiation Visit (SIV) Training materials for PV Operations.
    • Oversee SAE Reconciliation Plan and SMP development.
  • Study Management
    • Oversee ICSR and periodic report processing and submissions for assigned studies.
    • Represent PV Operations in cross‑functional, internal, and external study level meetings.
    • Resolve study level issues pertaining to PV Operations.
    • Support the PV Operations Team in providing study specific metrics, (KPIs and KQIs).
    • Oversee SAE Reconciliation for assigned studies.
  • Study Closeout
    • Oversee completion/closure of all applicable ICSR's and their submissions.
    • Oversee safety document archival.
• Oversight of PV
  • Support inspection readiness relating to PV activities.
  • Routine monitoring of compliance including monitoring of KPIs and KQIs to assess PV quality from CROs, vendors, external partners, and internal stakeholders; oversight of case processing activities and submission of SUSARs; submission of aggregate reports…