Senior Associate, Strategic Planning & Operations

Increasing demand for observational research (now commonly referred to as real-world evidence [RWE] from regulatory and reimbursement authorities makes observational research a keycomponentof 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. CfORscientistspartner 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 areseeking aSenior Associate, Strategic Planning & Operations, to join theCenter for Observational Research (CfOR).This role will work with other Amgen functional teamsto oversee and drive execution ofCfOR’soperational projects and non-interventional studies ensuringtimelycompletion within budget and at the highest qualitywith compliance. This role requires strong project management capabilities combined with a growth mindset and openness toleveragingemerging AI tools to improve productivity and drive CfOR-wide initiatives.

Key Responsibilities

• SupportCFOR team in end-to-end operational workflowsto improve efficiency inCfORoperational processsuch as budgeting, contracting, compliance activities and PMO office.

• DrivingAI-enabled operational transformationto enhance efficiencyincomplianceprocess, budget tracking, and decision-making across globalCfORprograms

• Provide specialized operational and documentation support for global observational research (RWE) studies, partnering with cross-functional scientific teams

• Project management experience including project planning, governance tracking, studies milestone management, risk/issue tracking, and stakeholder reporting

• SharePoint managementexperience incontent governance to enable effective collaboration and efficient document control.

Operational Excellence & Process Optimization:

• Supportend-to-endworkflows and process maps to improve efficiencyinCFOR operational process 

• Drive execution of operational processes by monitoring budgets, contracts, study milestones, risks, and performance metrics while ensuring data accuracy,timelyreporting, and adherence to regulatory, complianceand 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

• Identifyautomation opportunities to reduce manual effort and standardize workflows

• Creatingdashboardsof operational processes

• Drove adoptionand migrationof digital tools (Smartsheet,MS tools,Teams, SharePoint, Miro, lucid) for collaboration and tracking

ProjectManagementOffice

• Demonstrated experience in PMO practices, including project planning, governance tracking, milestone management, RAID tracking, and stakeholder reporting, ensuringtimelydelivery, quality, and alignment with business priorities.

• Ability to apply Agile, Scrum, Kanban, or hybrid project management methodologies to improve execution, collaboration, and operational efficiency andimprove project visibility and execution tracking.

Data, Reporting & Dashboarding:

• Developed andmaintainedoperational dashboards and reports (Power BI/Excel/Smartsheet) to track study performance, resourceutilization, and key KPIs

• Delivered actionable insights through data analysis and reporting to support leadership decision-making

Compliance& 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 degreewith7+years of Scientific or Operations experience OR

• Master’s degreeand5+years ofScientific or Operations experience

• Pharma/ Healthcare degree with application of technology/ AI knowledge expertise, advanced excel knowledge,dashboardcreation for reporting, and decision support.

Preferred Qualifications/Skills:

• Minimum of5years ofprojectmanagementexperience,with+3years in pharma/biotechandcross-functional environments

• Hands-onexperiencewithbudgeting, 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 prioritizeand 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 withdrug commercialization & business practices

• Comprehensive understanding of Good Clinical Practices (GCP),FDA regulations, and applicable regulatory/compliance frameworks critical to clinical and commercial operations