Senior Director, Safety Science (Patient Safety and Pharmacovigilance)

About Summit:

Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational

bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:

• HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).

• HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

• HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

Overview of Role:

The Senior Director of Safety Science reviews, leads, and executes strategic and day-to-day perspectives of Safety data, reports and evaluations.

Role and Responsibilities:

• Establish a signal management system and oversee signal management / signal detection activities.
• Interact, communicate, and collaborate effectively with cross-functional colleagues and development partners in a professional and autonomous fashion.
• Apply medical knowledge to effectively analyze safety data from various sources (e.g., toxicology, pre-clinical, clinical, post-approval, literature, etc.)
• Prepare presentations and effectively communicate (verbally and in writing) important safety concerns, and risk management evaluations when necessary to various internal and external audiences, including high-level committees such as the Drug Safety Committee (DSC), Independent Data Management Committees (IDMCs), and Executive Committee (EC) in a cogent and comprehensive manner.
• Establish and manage literature review plan for investigational products, and eventually for marketed products when necessary.
• Responsible for completion (including authoring and review) and submission of periodic safety reports (e.g., DSUR, PADER, PBRER reports) and collaboration with subject matter experts / functions to provide necessary periodic report content.
• Responsible for providing, preparing, authoring, or reviewing safety sections / content of regulatory response documents, investigator brochures (IB), referenced safety information (RSI) and RSI justification documents, clinical trial protocols, informed consent forms (ICFs), and clinical report forms (CRFs).
• Provide and review safety data for or contribute to the creation of regional product labels (package inserts) and company core data sheet (CCDS).
• Work with Medical Writers and Biometrics team to plan for tables, figures and listings (TFLs) and content to be included in clinical study reports (CSRs) and submission documents (e.g., summary of safety document module 2.7.4). Author and review sections within these documents when required within established delivery timelines.
• Responsible for establishing process for the writing, medical review and QC of CSR Safety Narratives in coordination with Clinical Development Team and Medical Writer (or contractor).
• Responsible for completion, providing, preparing, authoring, or reviewing safety sections/content) of risk management plans (RMPs).
• Work with QPPV officer and office, once established, and support the creation of the Pharmacovigilance system master file (PSMF).
• Determine safety topics for discussion at DSC meetings. Schedule, host, and prepare slides for scheduled and ad-hoc DSC meetings.
• Lead / Assist in developing, implementing, and supporting policies, standard operating procedures (SOPs), tools, etc., pertaining to Safety Science activities when needed; and contribute to cross-functional process development when needed.
• Support PV audits and inspections by p