Senior Associate - Strategic Planning & Operations

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

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