Associate Director, Data Management & Analytics IT

ASSOCIATE DIRECTOR, DATA MANAGEMENT & ANALYTICS IT

Location: Princeton, NJ ONSITE

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 Associate Director, Data Management & Analytics IT will work with Business and IT stakeholders to enable and deliver on the business priorities for clinical, commercial, sales and marketing division. Oversee build-out, implementation and maintenance of clinical and commercial data management systems and ensure scalability and accessibility of data services. The Associate Director will set the strategy and technology needs of the group and work closely with his/her team, Clinical Operations and Data Management, Commercial Sales Operations, Marketing, other IT resources and our partners. Oversee the build-out, implementation and maintenance of clinical, commercial systems to ensure scalability and accessibility of applications and services.

Ideal candidates will have IT experience driving IT initiatives from pre-commercial readiness to post-launch scalability in a Biopharmaceutical environment. Critical to have IT Clinical, Commercial background in Biotech/Pharmaceutical Industry. The position requires “hands on”, hardworking and dedicated individual with experience and ability to define, design, and implement all required systems to fully support the above process.

Role and Responsibilities:

• Develop and communicate a clear vision and strategy for the clinical data ecosystem especially with clinical trial design methodologies to enable clinical data exploration.

• Collaborate with cross-functional teams, including clinical operations, data management, IT, and external vendors, to deliver high-quality systems, solutions

• Develop and maintain dashboards, reports, and visualizations to support data-driven decision-making for Clinical.

• Ensure data integrity and accuracy across all clinical data systems.

• Align IT Commercial Strategy with corporate vision and business systems, especially for Commercial, Sales and Marketing

• Develop the IT Commercial and Operations team to maintain and modify commercial systems with the support of a 3rd party vendor as required; ensure team members are fully trained and understand the system dynamics and capabilities.

• Implement data strategy and vision to support single source of truth for Global Clinical, Commercial Data sets

• Design, Implement, and support Master Data Management systems for HCP’s, HCO’s and afflictions

• Lead and coordinate activities in Clinical, Commercial data projects and manage the end-to-end lifecycle of data ecosystem

• Collaborate with cross functional leadership to develop and maintain enterprise data models in support of the commercialization of drugs in the specialty setting, leveraging best practices in Data Warehousing, Master Data Management, and Business Intelligence

• Develop