Senior Associate, Strategic Planning & Operations

Career Category Strategy and Innovation 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 , t o join the Cent e r 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 CFOR team in end-to-end operational workflows to improve efficiency in CfOR operational process such as budgeting, contracting, compliance activities and PMO office.

Driving AI-enabled operational transformation to enhance efficiency in compliance process , budget tracking, and decision-making across global CfOR p rograms Provide specialized operational and documentation support for global observational research (RWE) studies, partnering with cross-functional scientific teams P roject management experience including project planning, governance tracking, studies milestone management, risk/issue tracking, and stakeholder reporting SharePoint management experience in content governance to enable effective collaboration and efficient document control.

Operational Excellence & Process Optimization: Support end-to-end workflows and 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.

Ensured 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 operational processes Identif y 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 Project Management Office Demonstrated experience in PMO practices, including project planning, governance tracking, milestone management, RAID tracking, and 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 Complianc e & Governance: Understanding compliance / governance activities, across eTMF, regukatory , inspection readiness, and submission processes, ensuring documentation completeness, traceability, and adherence to SOPs and regulatory requirements.

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 7 + years of Scientific or 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 5 years of project management experience, with + 3 years in pharma/biotech and cross-functional environments Hands-on experience with budgeting, vendor management, and regulated document management systems 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 Quick learner with strong analytical skills and adaptability to new tools and concepts Effective communicator with strong written, verbal, and presentation abilities Builds positive relationships and fosters collaboration with a proactive, “can-do” attitude Demonstrated proficiency & adaptability with related software tools ( ChatGPT, Copilot, Smartsheet, Miro, SharePoint, MS Teams, Office 365, etc.) Familiarity with drug commercialization & business practices Comprehensive understanding of Good Clinical Practices (GCP), FDA regulations, and applicable regulatory/compliance frameworks critical to clinical and commercial operations .