Job Description

Career Category

Clinical Development

Job Description

Job Description

Increasing demand for observational research (now commonly referred to as real-world evidence [RWE]) from regulatory and reimbursement authorities makes observational research a key component of drug development and commercialization. Amgen's Center for Observational Research (CfOR) is a global organization with an industry-leading analytical capability that generates RWE to support business needs across a product’s lifecycle. CfOR scientists partner with internal stakeholders and industry experts to design, conduct, interpret and publish observational research that informs decision-making from the early development of a molecule to the design of clinical trials and the safety and efficacy of Amgen medicines.

We are seeking a Senior Associate, Strategic Planning & Operations, to join the Center for Observational Research (CfOR). This role will work with other Amgen functional teams to oversee and drive execution of CfOR’s operational projects and non-interventional studies ensuring timely completion within budget and at the highest quality with compliance. This role requires strong project management capabilities combined with a growth mindset and openness to leveraging emerging AI tools to improve productivity and drive CfOR-wide initiatives.

Key Responsibilities

• Support end-to-end operational workflows/ automate tools and standardise process maps / SOPs to improve efficiency in CfOR operational process such as budget management, contracting, dashboard management and project management/ PMO office.
• Driving AI-enabled operational transformation to enhance efficiency in compliance process, budget tracking, and decision-making across global CfOR programs
• Project management including project planning, governance tracking, milestone management, Vendor onboarding, risk/issue tracking, and stakeholder reporting
• SharePoint management experience in content governance to enable effective collaboration and efficient document control.
• Knowledge management/ training capabilities - Design, track knowledge-sharing metrics and drive team engagement with continuous learning frameworks.

Operational Excellence & Process Optimization:

• Automate / standardize end-to-end workflows & process maps to improve efficiency in CFOR operational process
• Drive execution of operational processes by monitoring budgets, contracts, study milestones, risks, and performance metrics while ensuring data accuracy, timely reporting, and adherence to regulatory, compliance and organizational requirements.
• Ensure quality, compliance, and alignment with global operational standards
• Strong experience in SharePoint management, including site administration, document libraries, permission management, and content governance to enable secure collaboration and efficient document control

AI & Digital Enablement:

• Applied generative AI tools to improve productivity in documentation and operations
• Identify automation opportunities to reduce manual effort and standardize workflows
• Creating dashboards of operational processes
• Drove adoption and migration of digital tools (Smartsheet, MS tools, Teams, SharePoint, Miro, lucid) for collaboration and tracking
• Develop apps/ AI chatbots / migrate available processes to new technology/ tools based on organizational requirements

Project Management Office

• Demonstrated experience in PMO practices, including project planning, governance tracking, milestone management, stakeholder reporting, ensuring timely delivery, quality, and alignment with business priorities.
• Ability to apply Agile, Scrum, Kanban, or hybrid project management methodologies to improve execution, collaboration, and operational efficiency and improve project visibility and execution tracking.

Data, Reporting & Dashboarding:

• Developed and maintained operational dashboards and reports (Power BI/Excel/Smartsheet) to track study performance, resource utilization, and key KPIs
• Delivered actionable insights through data analysis and reporting to support leadership decision-making

Financial & Resource Management:

• Managed financial operations including PO processing, invoice verification, and expense tracking using SAP/Ariba/Anaplan
• Supported budget planning and resource management across programs

Basic Qualifications:

• Bachelor’s degree with 8+ years of Clinical / Scientific Operations experience OR
• Master’s degree and 5+ years of Scientific or Operations experience
• Pharma/ Healthcare degree with application of technology/ AI knowledge expertise, advanced excel knowledge, dashboard creation for reporting, and decision support.

Preferred Qualifications/Skills:

• Minimum of 6 years of project management experience, Agile Scrum master, with +4 years in pharma/biotech and cross-functional environments. Project planning & milestone tracking, process standardization & optimization, KPI design & reporting, cross-functional stakeholder management
• Technical: SQL, Python (incl. applied ML/predictive modeling), Tableau, Power BI & Analytics, Advanced Excel, Dashboard Creation & Reporting
• Hands-on experience with budgeting, contracting, PMO office, and working in regulated document management systems
• Drive AI-enabled operational transformation to enhance efficiency in CFoR operational process
• Demonstrated proficiency & adaptability with related software tools (ChatGPT, Copilot, Smartsheet, Miro, SharePoint, MS Teams, Office 365, etc.)
• Quick learner with strong analytical skills and adaptability to new tools and concepts
• Demonstrates autonomy and reliability in managing tasks and contributing to team goals
• Highly organized, with the ability to prioritize and deliver on projects independently or collaboratively
• Effective communicator with strong written, verbal, and presentation abilities
• Builds positive relationships and fosters collaboration with a proactive, “can-do” attitude
• Familiarity with drug commercialization & business practices