Sr Mgr Centralized Study Support

<h2><b>Career Category</b></h2>Clinical Development<h2></h2><h2><b>Job Description</b></h2><div><div><p><b><span>Role Name: </span></b><span><span>Sr </span><span>Manager Centralized Study Support (CSS)</span></span><span> </span></p></div><div><p><b><span>Role GCF: </span></b><span><span>6</span></span><span> </span></p></div><div><p><u><span>ABOUT AMGEN</span></u><span> </span></p></div><div><p><span><span>Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, </span><span>fuller</span><span> and longer. We discover, develop, </span><span>manufacture</span><span> and deliver innovative medicines to help millions of patients. Amgen helped </span><span>establish</span><span> the biotechnology industry more than 40 years ago and </span><span>remains</span><span> on the </span><span>cutting-edge</span><span> of innovation, using technology and human genetic data to push beyond </span><span>what’s</span><span> known today.</span></span><span> </span></p></div><div><p><span><span> </span></span><span> </span></p></div><div><p><u><span>ABOUT THE ROLE</span></u><span> </span></p></div><div><p><u><span>Role Description:</span></u><span> </span></p></div><div><p><span><span>The Sr Manager, </span><span>CSS</span><span> </span><span>is responsible for</span><span> strategic and operational leadership of multiple Managers within Centralized Study Support (CSS). This role ensures delivery of high</span></span><span><span>‑</span></span><span><span>quality centralized operational support across clinical programs and alignment of resources with organizational priorities.</span></span><span> </span></p></div><div><p><u><span>Roles &amp; Responsibilities:</span></u><span><span> </span></span><span> </span></p></div><div><p><b><span>Team Management</span></b><span> </span></p></div><div><ul><li><p><span><span>Provide leadership, direction and mentorship to multiple Managers, Centralized Study Support. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Set strategic goals for the team in collaboration with Sr </span><span>Mgr</span><span> colleagues and in alignment with corporate objectives</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ensure consistency in management practices, performance </span><span>standards</span><span> and staff development approaches across all managers. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Monitor functional performance against KPIs, addressing challenges and capitalizing on opportunities for improvement. </span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><b><span>Manager Development &amp; Support </span></b><span> </span></p></div><div><ul><li><p><span><span>Coach and mentor managers to enhance their leadership, performance </span><span>management</span><span> </span><span>&amp; team</span><span> building capabilities.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Support managers in addressing complex performance or resourcing challenges.</span></span><span> </span></p></li></ul></div></div><div><div><ul><li><p><span><span>Promote a culture of accountability, transparency, </span><span>quality</span><span> and continuous learning across all levels. </span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><b><span>Resource Planning &amp; Program Engagement</span></b><span> </span></p></div><div><ul><li><p><span><span>Oversee resource allocation across Managers’ teams ensuring </span><span>optimal</span><span> alignment with program requirements. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Anticipate resourcing risks and </span><span>pro-actively</span><span> develop &amp; execute effective mitigation plans. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Anticipate resourcing needs and partner with Talent Acquisition for </span><span>timely</span><span> hiring and succession planning. </span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><b><span>Stakeholder Collaboration &amp; Communication</span></b><span> </span></p></div><div><ul><li><p><span><span>Build strong trust-based relationships with key stakeholders and act as the senior operational contact for escalations involving centralized study support teams, </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Communicate succinct, effective functional updates, priorities, </span><span>risks</span><span> and successes to Director, SDRM</span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><b><span>Quality &amp; Compliance </span></b><span> </span></p></div><div><ul><li><p><span><span>Ensure all team members </span><span>operate</span><span> within SOPs, regulatory </span><span>guidelines</span><span> and quality standards.</span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><b><span>Capability Building &amp; Continuous Improvement </span></b><span> </span></p></div><div><ul><li><p><span><span>Identify</span><span> organizational skill gaps and develop a cohesive capability building strategy in partnership with Sr </span><span>Mgr</span><span>, CSS colleagues. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Lead initiatives to enhance processes, tools and systems that improve the quality, </span><span>efficiency</span><span> and consistency of CSS (</span><span>pro-actively</span><span> </span><span>leveraging</span><span> AI and other automation opportunities where </span><span>appropriate)</span><span>. </span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><b><span>Resource Management Support</span></b><span> </span></p></div><div><ul><li><p><span><span>Provide support to the SDRM team as needed</span><span>.  </span><span>Support may include management of hiring, allocations and forecasting analysis for in scope roles. </span></span><span> </span></p></li></ul></div></div><div><div><p><u><span>Basic Qualifications and Experience:</span></u><span> </span></p></div><div><ul><li><p><span><span>Doctorate degree and 2 years </span><span>of  clinical</span><span> execution experience OR</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Master’s degree and 6 years of clinical execution experience OR</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Bachelor’s degree and 8 years </span><span>of  clinical</span><span> execution experience OR</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Associate’s degree and 10 years </span><span>of  clinical</span><span> execution experience OR</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>High school diploma / GED and 12 years </span><span>of  clinical</span><span> execution experience</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>In addition to meeting at least one of the above requirements, you must have a minimum of 2 </span><span>years</span><span> experience</span><span> directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation </span><span>or</span><span> resources</span><span>.  </span><span>Your managerial experience may run concurrently with the required technical experience referenced above </span></span><span> </span></p></li></ul></div><div><p><u><span>Preferred</span><span> Qualifications and Experience:</span></u><span> </span></p></div><div><ul><li><p><span><span>7 </span><span>years</span><span> work experience in life sciences industry, particularly focusing on clinical trial work, including 5 years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Experience managing multiple teams / direct reports across multiple clinical functions</span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><u><span>Competencies</span><span>:</span></u><span> </span></p></div><div><ul><li><p><span><span>Ability to </span><span>identify</span><span> operational risks based on protocol design and implement innovative mitigation strategies. </span><span>Identify</span><span> and manage study issues, </span><span>communicating</span><span> and/or </span><span>escalating</span><span> appropriately.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Strong collaboration and communication skills to engage with cross-functional teams, senior </span><span>management</span><span> and external stakeholders, internally and externally</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Interprets</span><span> clinical and operational data to guide trial execution and </span><span>identify</span><span> study trends. </span><span>Collaborates</span><span> with biostatistics and data management to ensure data integrity</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ability to manage, mentor, and develop professionals and support staff across functions &amp; geographies, while fostering collaboration across internal and external teams for trial success</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Experience with overseeing study budgets and financial operations, reviewing/</span><span>approving</span><span> site expenditures, and </span><span>optimizing</span><span> resource allocation to ensure cost </span><span>efficiencies</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Able to </span><span>identify</span><span> and implement opportunities for continuous improvement </span><span>into</span><span> the team’s working practices</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Strong understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Experience with overseeing external vendors (Contract Research Organizations, labs, imaging vendors, etc.) to drive and meet study deliverables with high quality</span></span><span> </span></p></li></ul></div></div><div><div><ul><li><p><span><span>Navigates diverse regulatory, cultural, and operational environments</span><span>.  </span><span>Builds</span><span> strong relationships across geographies and time zones.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Experience with developing and training teams related to clinical trial materials (e.eg., CRAs, site staff, and cross-functional teams) to ensure alignment with study protocols, regulatory requirements, and best practices</span></span><span> </span></p></li></ul></div><div><p><u><span>EQUAL OPPORTUNITY STATEMENT</span></u><span> </span></p></div><div><p><span><span>Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.</span></span><span> </span></p></div><div><p><span><span>We will ensure that individuals with disabilities are provided with reasonable accommodation to </span><span>participate</span><span> 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 </span><span>an accommodation</span><span>.</span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><span> </span></p></div></div><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.