DIRECTOR CLINICAL DATA MANAGEMENTOverviewAt Amgen, every challenge is an opportunity. Our mission is to serve patients and advance biotechnical and biopharmaceutical science to help those with unmet medical needs.What You Will DoThe Amgen Global Clinical Data Management team is looking for an experienced Director to lead our data management team with the aim of delivering an industry– admired clinical evidence platform to bring innovative medicines to patients with unmet medical needs.You will lead and manage Data Management (DM) teams within a specific DM operational unit. The Director will set and drive the vision and strategy for DM as a member of the DM and GSO Leadership Team. You will be accountable for leadership and oversight of the DM organization, ensuring operational excellence and consistency in clinical trial execution. You will build and develop a high-performing internal DM team, and ensure engagement and alignment of Amgen’s strategy with the Functional Service Provider (FSP).You will be part of the Global Study Operations (GSO) leadership team, accountable for delivering quality clinical trials through innovative processes, cross-functional partnerships, and effective use of clinical systems and analytics to guide site and study operations. The role supports acceleration of clinical programs and continuous improvement efforts, shaping future strategy.Our Global Clinical Data Management Team comprises approximately 50 people. The three Directors, as part of the wider GSO organization, work to meet the demands of a fast-paced, high-throughput organization with a commitment to compliance, quality and standards.ResponsibilitiesOversight of a distinct DM operational unit (e.g., therapy area, cross‑product)Recruiting, managing and developing staffGlobal resource planning and assignmentsSetting functional goals and objectivesCreating and implementing GSO & DM strategies, developing, reviewing, implementing and enforcing data standardsEnsuring DM processes/systems meet regulatory and business requirementsBe an active member of the Leadership Team to support GSO successKey activitiesTeam management including performance, coaching and developmentDevelop, review and implement policies, SOPs and related documents affecting DM globallySet vision, strategy and direction for the DM group; develop annual goalsAccountable for DM FSP relationships; ensuring goals of product areas and systems groups can be met via the FSPDefine and maintain Service Level Agreements and KPIs; oversight of quality and CAPA managementGovernance oversight – ensure visibility into FSP performanceSponsor, lead and participate in cross-functional working groupsResource and budget management; ensure training and staff compliance with DM processesVendor management (strategy, contract management, relationship management)Respond to audit/inspection findingsOversee study deliverables and submission activities for products within the groupEnsure DM activity status information is current and acted on as neededWhat We Expect Of YouWe value collaboration and the unique contributions of our team. The data management professional we seek is a collaborator with these qualifications.Degree in a relevant field (life sciences, computer science, business administration or related)Extensive data management experience in Pharma/BiotechLeadership experience in rare disease therapeutic areaExperience in global organizations and oversight of outside vendors (CROs, central labs, imaging vendors, etc.)Extensive managerial experience leading teams, projects, programs or resource allocationStrategic and innovative thinker with operational excellence experienceExcellent relationship-building skills with ability to influence and drive business impactCollaborative cross-functional work with influence to drive decisionsExperience overseeing clinical research suppliersProject managementGlobal, matrix organization experienceExcellent organizational and interpersonal skillsAbility to anticipate and solve challenging issuesThriveWe invest in your growth and well-being as we work to develop treatments that help others.Opportunities to learn and move across our global organizationDiverse and inclusive community that values ideas and actionGenerous Total Rewards Plan including health, finance and wealth, work/life balanceLocationAbility to work flexibly from home with regular office work from our Cambridge or Uxbridge next-generation workspace.Apply Nowfor a career that defies imaginationJoin us in serving patients above all else. Amgen is the first to imagine, and the last to doubt.careers.amgen.comEqual Opportunity StatementAmgen is an Equal Opportunity employer and will consider you without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We provide reasonable accommodations in the job application or interview process upon request. #J-18808-Ljbffr