Senior Manager, IT Security, Compliance & Infrastructure

Sr. Manager, IT Security, Compliance & Infrastructure

Location: Onsite in Palo Alto, CA or Princeton, NJ

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:

As the Senior Manager, Security, Compliance & Infrastructure, the candidate will be responsible for establishing and leading the Information Technology security program while also supporting core infrastructure operations. This includes designing, implementing, and managing security policies, processes, and controls in alignment with GxP and regulatory requirements, as well as ensuring the stability, scalability, and efficiency of our Microsoft cloud-based infrastructure. The ideal candidate will bring proven expertise in security along with hands-on experience in GxP processes and validated systems.

Role and Responsibilities:

· Establish and lead the Information Technology security program in alignment with the NIST Cybersecurity Framework (CSF).

· Collaborate with technical and non-technical partners to ensure policies, procedures., work instructions, and practices are compliant with various regulatory authorities including but not limited to SOX, FDA pharmaceutical Industry validation (GXP) and 21 CFR Part11, HIPAA, EU data privacy (GDPR), NIST Cyber Security Framework (CSF), etc.

· Scale and optimize Microsoft security tools (Defender, Purview, Sentinel, Intune, Entra ID, etc.) for threat protection, identity management, and data governance.

· Lead data privacy and protection initiatives, ensuring proper controls for sensitive clinical, R&D, and regulated data.

· Develop and enforce policies for responsible AI use within the organization, ensuring compliance, data security, and ethical application of AI technologies.

· Conduct and lead risk assessments, vulnerability management, and incident response programs.

· Ensure readiness for internal and external au