Executive Director, Biostatistics

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 Summits 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 Executive Director of Biostatistics serves as the Biostatistics Lead for multiple oncology projects providing strategic and technical leadership as well as statistical support in the development and execution of statistical strategies study designs statistical analyses and regulatory submissions. They will collaborate with clinical science regulatory and other functions on clinical development plans the authorship of key clinical regulatory statistical documents and ensuring the high-quality delivery and accurate interpretation of clinical data. The Executive Director will develop and implement biostatistics department policies standards procedures and work instructions in coordination with the department leader and other functions. Additionally they will represent biostatistics function in interactions with CROs institutional review boards and regulatory agencies. This role includes direct supervisory responsibilities for internal staff or external consultants.

Role and Responsibilities:

• Serve as the Biostatistics Lead for multiple oncology projects
• Provide strategic and technical leadership along with statistical support to clinical development in the design and conduct of late-stage oncology trials
• Provide strategic input and guidance to ensure the high quality of Regulatory Authority documents including clinical protocols statistical analysis plans study reports briefing books submissions and safety reports
• Collaborate with cross-functional teams to ensure accurate interpretation of study results and high-quality study reports and publications
• Write and review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and processes
• Lead the assessment and implementation of novel statistical methodologies to drive solutions
• Represent the biostatistics function or biometrics department in cross-functional teams
• Collaborate with the department leader to develop and implement policies standards and procedures
• Develop strong collaborative relationships with key business stakeholders including project leaders in Regulatory Clinical Development Clinical Operations Research and other functions
• Assess and manage CROs and other vendors including scope-of-work timelines deliverables and budgets
• Stay up to date with FDA and EMA regulations guidance emerging trial designs for marketing authorization and communicate relevant updates to key stakeholders
• Participate in meetings with FDA and other health authorities to ensure alignment on project development
• Provide mentorship and coaching to direct reports to help them reach their full potential
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• Ph.D. in Statistics Biostatistics or equivalent area with 15 years biopharmaceutical industry experience or MS degree in related discipline with extensive industry and leadership experience with 18 years biopharmaceutical industry experience required
• A minimum of 3 years of experience in team leadership and managing direct reports is required
• 10 years of experience in oncology clinical trials including trial design and execution with a strong background in late-stage clinical trials

• Extensive knowledge of clinical trial development and statistical methodologies related to trial design and execution is required with experience in late-stage oncology trials and regulatory submissions essential

• Experience in providing statistical support for Medical Affairs and Market Access activities is highly preferred

• Experience interacting with health authorities

• Comprehensive knowledge of ICH FDA and GCP regulations and guidelines with strong well-rounded technical skills

• Excellent organizational skills

• Critical thinking problem solving ability to work independently

• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents

• Communicate effectively and articulate complex ideas in an easily understandable way

• Prioritize conflicting demands

• Work in a fast-paced demanding and collaborative environment

The pay range for this role is $224000-$285000 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.

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