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 dynamic, adaptable, and tech-savvy **Strategic Planning & Operations Manager** 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:
+ Develop strong collaborative relationships with stakeholders across CfOR and Amgen, ensuring alignment with strategic objectives and operational priorities.
+ Lead the planning, coordination, and execution of projects using Agile methodologies. Develop and maintain detailed project plans, facilitate meetings, track milestones, ensuring adherence to workflow processes.
+ Provide ongoing support for headcount management, requisition tracking, staffing analysis, and organizational planning in alignment with CfOR leadership goals and strategic direction.
+ Lead adoption and integration of platforms such as Smartsheet, Microsoft Teams, and Miro to enhance team collaboration and project tracking.
+ Lead or support strategic initiatives, including operational pilots, change management efforts, and AI experimentation that elevate CfOR’s organizational capabilities.
+ Communicate status and issues effectively to appropriate parties, both within CfOR and across Amgen.
+ Wear multiple hats as needed – Support Operations Head, lead special projects, conduct required analysis and create deliverables as needed.
+ Identify and implement improvements to operational processes using AI tools and technology increasing team efficiency, reducing manual tasks.
+ Leverage the use of productivity and generative AI tools, including Microsoft Copilot, ChatGPT, and AI agents, to streamline workflows, documentation, meeting summaries, data analysis, and communications.
**Basic Qualifications**
+ Doctorate degree and 2 years of research and program management experience Or
+ Master’s degree and 6 years of research and program management experience Or
+ Bachelor’s degree and 8 years of related experience Or
+ Associate degree and 10 years of related experience Or
+ High school diploma / GED and 12 years of related experience
**Preferred Qualifications**
+ Minimum of 10 years of project management experience, including 5+ years in pharma/biotech within regulated, cross-functional environments.
+ Proven ability to lead complex projects end-to-end in fast-paced, matrixed settings; experienced in budgeting, resource planning, vendor management, and risk mitigation.
+ Skilled at managing ambiguity and shifting priorities through structured thinking, stakeholder alignment, and agile decision-making.
+ Highly motivated and proactive professional who thrives with minimal supervision, balancing multiple initiatives while ensuring compliance with regulatory standards and organizational processes.
+ Expertise in evaluating current-state operations and designing scalable, creative solutions improving efficiency, quality, stakeholder satisfaction.
+ Superior communication and presentation skills with ability to translate complex data into dashboards for diverse stakeholders, including SLTs.
+ Experience with Agile frameworks (SAFe – highly preferred), Scrum, and Kanban, with a focus on digital transformation and operational efficiency.
+ Comprehensive understanding of Good Clinical Practices (GCP), FDA regulations, and applicable regulatory/compliance frameworks critical to clinical and commercial operations.
+ Familiarity with drug commercialization & business practices.
+ High proficiency in Smartsheet, Microsoft O365, and Miro, with a focus on leveraging tools for planning, tracking, and visual collaboration.
+ Passionate about continuous improvement and applying emerging technologies (e.g., Generative AI, agents) to increase productivity, automate repetitive tasks, and enhance stakeholder engagement.
+ Working knowledge of AI tools such as Microsoft Copilot, ChatGPT, and AI Agents, with practical experience integrating these into project workflows.
