Career Category

Clinical Development

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. 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:

Financial & Supplier Management:

• Execute and manage consulting, external research and data license contracts with commercial suppliers, healthcare professionals, and academic institutions
• Execute financial transactions, including purchase order processing, invoice verification, payment processing, and engaging with other functions to help plan and manage resource expenses, using Anaplan, Ariba or SAP software.
• Collaborate closely with cross functional team, including Legal, Global Strategic Sourcing, Compliance, Supplier Governance, Safety and Finance.
• Support resource and supplier expense planning. Plan and track study spend, and report changes to finance and budget holders.
• Manage payment inquiries that are received from HCPs (Healthcare Professionals), Scientists, Service Providers, etc.
• Perform supplier qualifications and assist in competitive bidding process if required.
• Conduct regular meetings with study leads to discuss operational activities.
• Identify potential department/cross functional process improvement activities.
• Track and review study milestones and deliverables ensuring accurate data population within internal systems.

Strategic & Operational Excellence:

• Support strategic initiatives and operational pilots
• Identify cross-functional process improvement opportunities
• Develop and maintain process flow diagrams

Technology & Automation:

• Support adoption of platforms (Smartsheet, Power BI, Power Automate, etc.)
• Identify opportunities to automate manual workflows

Basic Qualifications:

• High school diploma and 10+ years of Scientific or Operations experience OR
• Associate degree and 8+ years of Scientific or Operations experience OR
• Bachelor’s degree and 6+ years of Scientific or Operations experience OR
• Master’s degree and 4+ years of Scientific or Operations experience

Desirable Qualifications/Skills:

• Minimum of 3 years of project management experience, with 2+ years in pharma/biotech within regulated, cross-functional environments
• Effective communicator with strong written, verbal, and presentation abilities
• 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
• Demonstrated aptitude for collaboration & relationship building. Builds positive relationships and fosters collaboration with a proactive, “can-do” attitude
• Demonstrated proficiency & adaptability with related software tools (ChatGPT, Copilot, Smartsheet, Power BI, Power Automate, Miro, Share Point, MS Teams, Office 365, etc.)
• Familiarity with drug commercialization & business practices
• Foundational understanding of Good Pharmacovigilance Practice (GPvP), Good Clinical Practice (GCP), FDA regulations, and relevant regulatory and compliance frameworks supporting clinical and commercial operations

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