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 and drive a strong data stewardship program among all business functions with priority focus on the Commercial Enterprise: Drug Supply Chain (3PL), Patient HUB Services, Finance, Compliance, Medical Affairs, Commercial Operations, Market Access, Marketing, and Sales Operations

• Collaborate with internal and external business and technical teams, notably working with third party data aggregators and systems engineers to architect and harmonize comprehensive, flexible, and scalable data acquisition, data management, stewardship, and quality strategies

• Responsible for timely delivery of project initiatives achieved through experience-driven vision and planning skills and effective external vendor management.

• Establishes and fosters relationships with business stakeholders and service providers

• Demonstrate commitment and support for company goals, objectives and procedures

• Demonstrate professionalism and adherence to moral, ethical, and quality principles

• Comply with applicable regulations, GCP and corporate policies and procedures

• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• A Bachelor’s degree or equivalent in Computer Information Systems or relative field

• Minimum 8+ years’ experience in a Pre commercial, Commercial drug enterprise in a data management and/or data warehousing capacity

• Minimum 8+ years’ experience working with third-party data and service providers and data aggregators

• Strong understanding of Pharmaceutical Data and Master Data Management platform (e.g. Veeva Network)

• Strong understanding of clinical data systems (e.g., EDC, CTMS, Safety)

• Experience with major pharma enterprise data providers and business operations, including but not limited to 3PL supply chain and specialty distribution networks, Patient HUB Services, Corporate Finance / Compliance, and Commercial Operations

• Experience with data warehouse architecture, data normalization best practices for reporting and analytics, data quality and master data management principles. Experience working with data imports/exports processes with third-party data and service providers, and data integration methods with source and target business systems

• Minimum 2+ years managerial and/or IT leadership with increasing responsibilities with strong mentorship abilities

• Strong understanding of regulatory compliance requirements related to technology systems in the pharmaceutical industry (e.g., CSV, 21 CFR Part11, HIPAA, GDPR)

• A “hands-on” self-starter with some managerial/leadership experience and a demonstrated ability to interact with technical and non-technical staff, various levels of management, and external parties to accomplish goals and objectives

• Demonstrated ability to anticipate, proactively respond to trends and/or shifts in the external environment (e.g., regulatory, vendor relationships, industry standards)

• Self-motivated, proactive team player and collaborator

The pay range for this role is $175,000 to $190,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.