Sr Manager Centralized Study Support (CSS)

Career Category

Job Description

ABOUT AMGEN 

Amgen 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 ROLE 

Role Description: 

The Sr Manager, CSS is responsible for strategic and operational leadership of multiple Managers within Centralized Study Support (CSS). This role ensures delivery of high‑quality centralized operational support across clinical programs and alignment of resources with organizational priorities. 

Roles & Responsibilities:  

Team Management 

• Provide leadership, direction and mentorship to multiple Managers, Centralized Study Support.  

• Set strategic goals for the team in collaboration with Sr Mgr colleagues and in alignment with corporate objectives 

• Ensure consistency in management practices, performance standards and staff development approaches across all managers.  

• Monitor functional performance against KPIs, addressing challenges and capitalizing on opportunities for improvement.  

Manager Development & Support  

• Coach and mentor managers to enhance their leadership, performance management & team building capabilities. 

• Support managers in addressing complex performance or resourcing challenges. 

• Promote a culture of accountability, transparency, quality and continuous learning across all levels.  

Resource Planning & Program Engagement 

• Oversee resource allocation across Managers’ teams ensuring optimal alignment with program requirements.  

• Anticipate resourcing risks and pro-actively develop & execute effective mitigation plans.  

• Anticipate resourcing needs and partner with Talent Acquisition for timely hiring and succession planning.  

Stakeholder Collaboration & Communication 

• Build strong trust-based relationships with key stakeholders and act as the senior operational contact for escalations involving centralized study support teams,  

• Communicate succinct, effective functional updates, priorities, risks and successes to Director, SDRM 

Quality & Compliance  

• Ensure all team members operate within SOPs, regulatory guidelines and quality standards. 

Capability Building & Continuous Improvement  

• Identify organizational skill gaps and develop a cohesive capability building strategy in partnership with Sr Mgr, CSS colleagues.  

• Lead initiatives to enhance processes, tools and systems that improve the quality, efficiency and consistency of CSS (pro-actively leveraging AI and other automation opportunities where appropriate).  

Resource Management Support 

• Provide support to the SDRM team as needed.  Support may include management of hiring, allocations and forecasting analysis for in scope roles.  

Basic Qualifications and Experience: 

• Doctorate degree and 2 years of  clinical execution experience OR 

• Master’s degree and 6 years of clinical execution experience OR 

• Bachelor’s degree and 8 years of  clinical execution experience OR 

• Associate’s degree and 10 years of  clinical execution experience OR 

• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.  Your managerial experience may run concurrently with the required technical experience referenced above  

Preferred Qualifications and Experience: 

• 12+ years 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 

• Experience managing multiple teams / direct reports across multiple clinical functions 

Competencies: 

• Ability to identify operational risks based on protocol design and implement innovative mitigation strategies. Identify and manage study issues, communicating and/or escalating appropriately. 

• Strong collaboration and communication skills to engage with cross-functional teams, senior management and external stakeholders, internally and externally 

• Interprets clinical and operational data to guide trial execution and identify study trends. Collaborates with biostatistics and data management to ensure data integrity 

• Ability to manage, mentor, and develop professionals and support staff across functions & geographies, while fostering collaboration across internal and external teams for trial success 

• Experience with overseeing study budgets and financial operations, reviewing/approving site expenditures, and optimizing resource allocation to ensure cost efficiencies 

• Able to identify and implement opportunities for continuous improvement into the team’s working practices 

• Strong understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles  

• Experience with overseeing external vendors (Contract Research Organizations, labs, imaging vendors, etc.) to drive and meet study deliverables with high quality 

• Navigates diverse regulatory, cultural, and operational environments.  Builds strong relationships across geographies and time zones. 

• 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