Capability Development & Continuous Improvement
Identify gaps in skills, processes, or tools and implement targeted development or training initiatives.
Support knowledge sharing across the team to build collective expertise.
Encourage innovative solutions and best practice adoption to enhance operational effectiveness.
Stakeholder Collaboration
Serve as the main point of contact for performance escalations related to CSS team members
Build strong relationships with internal stakeholders to align team development & allocation with the broader needs of the business
Quality & Compliance
Support the development of team oversight metrics and regularly report progress towards them / swiftly address risks & issues.
Ensure all team members operate within SOPs, regulatory guidelines and quality standards.
Support audit & inspection readiness.
Resource Management Support
Provide support to the SDRM Resource Management team as needed. Support may include management of hiring, allocations and forecasting analysis for in scope roles.
Basic Qualifications and Experience
Doctorate degree OR
Master’s degree and 8 years of clinical execution experience OR
Bachelor’s degree and 10 years of clinical execution experience of clinical execution experience
Preferred Qualifications and Experience
5 years work experience in life sciences industry, particularly focusing on clinical trial work, including 3 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 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
Strong collaboration and communication skills to engage with cross-functional teams, senior management and external stakeholders, internally and externally
Strong understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles
Navigates diverse regulatory, cultural, and operational environments. Builds strong relationships across geographies and time zones.
Ability to identify operational risks based on protocol design and implement innovative mitigation strategies. Identify and manage study issues, communicating and/or escalating appropriately.
Able to identify and implement opportunities for continuous improvement into the team’s working practices
Clear understanding of risk-based site monitoring ensuring regulatory compliance and timely implementation of Corrective and Preventive Actions (CAPA) to mitigate risks, resolve operational challenges and ensure inspection readiness
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
EQUAL OPPORTUNITY STATEMENT
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.
We will ensure that individuals with disabilities are provided with 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 accommodation.
.
