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 of Project Management sits within the Program Management and Business Strategy department and is pivotal in contributing to a fit for purpose PMO and driving cross-functional execution and operational excellence across oncology development programs, particularly Phase 2 and beyond. The Associate Director will serve as a strategic integrator, aligning corporate and clinical development goals with functional execution across departments such as Clinical Operations, Development, Biometrics, Regulatory, Clinical Pharmacology, Biomarker Strategy, Bioanalytical, New Indication Planning, Quality, IT and Compliance.

This role will be responsible for building and refining infrastructure and processes that support scalable, transparent, and adaptive program execution. This includes dashboarding, process improvement and continuous monitoring to ensure visibility, accountability, and agility as the organization grows and our pipeline evolves.

Role and Responsibilities: Project Management Develop integrated project plans, timelines, and templates from scratch tailored to program, cross functional, and governance needs. Drive execution of project milestones, proactively identifying risks and mitigation strategies. Ensure alignment between functional execution and strategic program goals. Lead and manage ad-hoc cross functional workstreams on specific initiatives.

Functional Integration Serve as a project management strategic liaison to 1-2 functional departments (e.g., Clin Ops, Biometrics, Clinical Quality, Clin Dev). Translate functional needs into actionable infrastructure and project plans. Support functional teams in achieving operational excellence and compliance.

Process Improvement & PMO development Design and implement scalable, adaptable processes that support program execution. Lead initiatives to improve operational efficiency, transparency, and agility. Ensure all infrastructure initiatives are documented and integrated into the PMO library. Apply continuous monitoring and feedback loops to refine processes as the organization evolves.

Dashboarding & Visibility Develop and maintain dashboards using Smartsheets and other tools to track timelines, deliverables, and risks. Ensure real-time visibility into project status for leadership and stakeholders. Champion data-driven decision-making through effective reporting and visualization.

Leadership & Collaboration Navigate ambiguity with confidence and clarity. Be a self-starter while knowing when to seek input and guidance. Lead diverse teams in both direct and matrixed environments. Foster strong relationships across functions and levels of the organization.

All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Education Minimum of a Bachelor's degree, preferably in a scientific or business discipline. Master's degree preferred.

Experience Minimum of 8+ years in a pharmaceutical company or CRO. Direct experience in oncology drug development (Phase 2 and beyond). Expertise in drug development, financial operations, and strategic planning. Strong project management experience: PMP certification preferred. Experience leading diverse teams in direct and matrixed environments.

Technical Skills: Proficiency in Smartsheets and dashboarding tools. Experience with systems such as Veeva, SAP, CTMS, Janus, Power BI highly preferred. Solid understanding of financial aspects of clinical operations. Prior experience in resource planning, capacity management and project baselining highly preferred. Ability to derive key insights on complex topics and deliver verbal and written communications accordingly.

Core Competencies: Effective leadership and team-building skills. Excellent communication, analytical, and conceptual skills. Strong planning and organizational abilities with a focus on results. Performance-driven with the ability to lead and deliver in complex environments. Skilled in recommending and implementing process improvements. Capable of managing multiple projects simultaneously.

The pay range for this role is $153,000-$180,000 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.