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, SharePoint, 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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