Associate Director Program Data Delivery

Career CategoryClinical DevelopmentJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.ABOUT THE ROLERole Description:The Associate Director, Program Data Delivery provides  program-level leadership in complex programs and will be accountable for ensuring high-quality, inspection-ready data across  studies and programs as needed , driving alignment, consistency, standardization, scalability, and innovation from study planning through database lock.This role leads and mentors a pod of Data Delivery Leads and  Central Monitors ensuring standardized, scalable, and inspection-ready delivery across the portfolio.The Associate Director serves as the strategic Data Management leader, responsible for shaping delivery models within a therapeutic area, influencing cross-functional decisions, and driving continuous improvement and innovation across programs.STRATEGIC PILLAR Define and drive Data Delivery strategy at the program level, aligned to GDO prioritiesShape and evolve operating models for Program Data Delivery and Central Monitoring, including monitoring of resource needs, governance, and delivery frameworksLead standardization and modernization initiatives (e.g., integrated data review approach, risk-based data management, advanced automation, etc.) across programsInfluence portfolio prioritization, risk trade-offs, and execution strategies in partnership with Clinical Operations, Biostatistics,Safety, and Medical MonitoringRepresent Data Management in senior governance forums, providing strategic insights and recommendationsBuild sustainable and scalable capability models (talent, tools, and processes) to support portfolio growthRoles & Responsibilities:Portfolio & Program Delivery OversightAccountable for end-to-end delivery of high-quality, inspection-ready clinical data across multiple programs, ensuring adherence to timelines, regulatory requirements, and quality standards, while driving consistent database readiness, data cleaning, reconciliation, and seamless database lock execution.Drive program-level adoption and cross-study standardization of data management practices - including DMP, IDRP, query management, and reconciliation—to improve efficiency, consistency, and scalability across programsManage inter-study dependencies, timelines, and critical paths to ensure seamless program execution and delivery alignmentDrive adoption of advanced analytics, automation, and AI-enabled data review to enhance data quality, efficiency, and insight generationEnsure continuous inspection readiness and proactively support regulatory inspections and auditsLeadership of Program Data Delivery & Central MonitoringLead pods of Data Delivery Leads, and Central Monitors and mentor Program Data Delivery LeadsDrive consistent execution through clear expectations and performance accountabilityBuild leadership capability and pipeline through mentorship and developmentEnsure effective central monitoring for early risk detectionRisk Management & GovernanceOwn portfolio-level risk strategy, including identification, escalation, and mitigationTranslate program risks into portfolio insights and proactive actionsLead governance forums and drive resolution of complex cross-functional issuesServe as escalation point for critical data delivery risksMetrics, Insights & Decision SupportOversee key program metrics, ensuring timely actions, resolution, and closure of identified issuesLeverage analytics to identify trends, risks, and improvement opportunities across programsProvide clear, actionable portfolio insights to senior leadership, enabling informed, data-driven decisions and effective trade-off managementCross-Functional & Vendor LeadershipInfluence across Clinical Operations, Biostatistics, Safety, Systems, and vendorsAlign program execution with portfolio and enterprise prioritiesOversee vendor performance and delivery quality at scaleProcess Excellence & TransformationDrive adoption of standardized methodologies and best practicesLead improvements to enhance efficiency, scalability, and qualityChampion innovation in central monitoring and data reviewBasic Qualifications and Experience:Doctorate /Master’s Degree /bachelor’s degree with 15+ years of experience in life sciences / clinical data managementProven experience leading programs/portfolios in clinical data managementDemonstrated people leadership and organizational management experience.Preferred Experience:15+ years’ work experience in life sciences or medically related field, including 10 years of managing data on biopharmaceutical clinical research experienceExtensive experience in Program Data Delivery and Central Monitoring modelsStrong experience in portfolio oversight across multiple global clinical trialsDemonstrated ability to operate at both strategic and execution levelsExperience influencing in matrixed, global environmentsExperience leading teams, transformation and modernization initiativesExperience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trialsExperience with managing data collection and oversight with external vendor (CROs, central labs, imaging vendors, etc.)Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management.Functional Competencies:Must-Have Competencies:Ability to lead portfolio-scale delivery and influence enterprise-level decisionsStrong capability to identify cross-program risks and drive mitigation strategiesExpertise in interpreting complex clinical and operational data to guide portfolio executionAbility to dri