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 eg 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 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 ManagementDevelop 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 strategiesEnsure alignment between functional execution and strategic program goalsLead and manage ad hoc cross functional workstreams on specific initiativesFunctional IntegrationServe as a project management strategic liaison to 12 functional departments eg Clin Ops Biometrics Clinical Quality Clin DevTranslate functional needs into actionable infrastructure and project plansSupport functional teams in achieving operational excellence and complianceProcess Improvement & PMO development Design and implement scalable adaptable processes that support program executionLead initiatives to improve operational efficiency transparency and agilityEnsure all infrastructure initiatives are documented and integrated into the PMO libraryApply continuous monitoring and feedback loops to refine processes as the organization evolvesDashboarding & VisibilityDevelop and maintain dashboards using Smartsheets and other tools to track timelines deliverables and risksEnsure real time visibility into project status for leadership and stakeholdersChampion data driven decision making through effective reporting and visualizationLeadership & CollaborationNavigate ambiguity with confidence and clarityBe a self starter while knowing when to seek input and guidanceLead diverse teams in both direct and matrixed environmentsFoster strong relationships across functions and levels of the organizationAll other duties as assignedExperience Education and Specialized Knowledge and Skills EducationMinimum of a Bachelors degree preferably in a scientific or business discipline Masters degree preferredExperienceMinimum 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 environmentsTechnical SkillsProficiency in Smartsheets and dashboarding toolsExperience with systems such as Veeva SAP CTMS Janus Power BI highly preferredSolid understanding of financial aspects of clinical operationsPrior 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 CompetenciesEffective leadership and team building skillsExcellent communication analytical and conceptual skillsStrong planning and organizational abilities with a focus on resultsPerformance driven with the ability to lead and deliver in complex environmentsSkilled in recommending and implementing process improvementsCapable of managing multiple projects simultaneously The pay range for this role is 153000 180000 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 andor other applicable variable compensation Summit does not accept referrals from employment businesses andor employment agencies in respect of the vacancies posted on this site All employment businessesagencies are required to contact Summits Talent Acquisition team atrecruitingsmmttxcomto obtain prior written authorization before referring any candidates to Summit
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Industry
Chemical Manufacturing