Director Clinical Data Management

Overview

HOW MIGHT YOU DEFY IMAGINATION?At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.Director Clinical Data Management

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What You Will DoThe Amgen Global Clinical Data Management team is looking for an experienced Director to lead our data management team on the aspiration of optimizing and delivering an industry admired clinical evidence platform to deliver innovative medicines to patients with unmet medical needs.You will lead and manage Data Management (DM) teams within a specific DM operational business unit. The Director will set and drive forward 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 data management organization; ensuring operational excellence and consistency in clinical trial execution. In this role you will be accountable for building and developing a high performing internal data management team, as well as ensuring engagement and alignment of Amgen’s strategy and priorities with the Functional Service Provider (FSP).In this role you will be part of the Global Study Operations (GSO) leadership team, accountable for the delivery of quality clinical trials through industry-leading execution of innovative processes, strong cross-functional partnerships, and best-use of clinical systems and analytics to guide site and study operations. The role will support acceleration of clinical programs and other continuous improvement efforts, applying innovative thinking in shaping future strategy.Our Global Clinical Data Management Team:The Global Clinical Data Management Team comprises approximately 50 people. The three Directors, as part of the wider GSO organization and reporting into the Executive Director, Global Study Operations, work together to meet the demands of an industry leading, fast paced, high throughput organization with a commitment to compliance, quality and standards.Responsibilities:Oversight of a distinct DM operational unit (e.g. therapy area, cross-product area)Recruiting, managing and developing staffGlobal resource planning and assignmentsSetting of functional goals and objectivesCreating and implementing GSO and 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 provide a foundation for GSO successKey activities will include:Team management including performance, coaching and developmentDevelop, review and implement policies, SOPs and associated documents affecting DM globallySet vision, strategy and direction for DM group; develop annual goals and objectivesAccountable for and oversee DM FSP relationships; ensuring goals of product areas and systems groups can be met via the FSPDefine and maintain Service Level Agreements and Key Performance Indicators; including oversight of quality and CAPA managementGovernance oversight -ensure visibility into performance of FSPs to the departmentSponsor, Lead and participate in cross functional working groupsResource and budget management for global function Ensure adequate training and capability within area and be accountable for staff compliance with all DM processesVendor management (development of strategies, contract management, relationship management, etc)Respond to audit/inspection findingsBe accountable for and oversee all study deliverables and submission activities for products within groupEnsure that status information on DM activities is available and is acted on as neededWin

What We Expect Of YouWe are all different, yet we all use our unique contributions to serve patients. The data management professional we seek is a collaborator with these qualifications.Degree educated in relevant field or in life science, computer science, business administration or related disciplineExtensive experience in data management in the Pharmaceutical or Biotech arenaExperience in rare disease therapeutic area in a leadership roleBroad experience of working in a global organizationExperience at or oversight of outside vendors (CRO’s, central labs, imaging vendors, etc)Extensive managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resourcesStrategic and innovative thinker with experience of driving operational excellenceExcellent relationship building skills with the ability to influence and make business impactAbility to work collaboratively cross functionally with ability to influence and drive decisionsProven experience within oversight of clinical research suppliersProject managementPrevious experience in a global, matrix organizationExcellent organizational and interpersonal skillsAbility to anticipate and problem solve challenging issuesThrive

What you can expect of usAs we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.Vast opportunities to learn and move up and across our global organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsLOCATION:

Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.APPLY NOWfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comEqual Opportunity StatementAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an ..... full job details .....