Amgen
biotechnology
OperationsManager,DigitalMedicine
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Operations Manager, Digital Medicine at Amgen. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, study-level design, execution of digital medicine studies, integrating pragmatic and decentralized approaches into clinical trials, digital health technologies, decentralized methodologies. Contribute to study design by integrating pragmatic and decentralized elements aligned with clinical and prod”
What You'll Achieve.
ensuring the delivery of the best medicines to benefit patients; operational excellence
Industry & Context.
What They're Looking For.
Must Have
Doctorate degree and 4 years of relevant experience, Master’s degree and 7 years of relevant experience, Bachelor’s degree and 9 years of relevant experience
Nice to Have
Minimum of 8 years of experience in clinical development, digital health, or related field, including leadership in DCTs and pragmatic trials., Preferably in cardiovascular, rare diseases, oncology and inflammation., Deep understanding of clinical trial operations, regulatory requirements, and digital health technologies., Proven experience implementing digital strategies in clinical research at a global or regional level., communication and stakeholder management ability to influence across levels and functions., Post Marketing / Phase 4 experience
What You'll Do.
Contribute to study design by integrating pragmatic and decentralized elements aligned with clinical and product strategy
Translate digital medicine strategy into actionable study-level plans
including selection of endpoints
and operational approaches
Provide input on protocol design
and patient-centric approaches enabled by digital solutions
Ensure alignment between digital design elements and study objectives
and regulatory considerations
Ensure successful implementation of decentralized trial elements (e. g.
hybrid/virtual visits)
and performance of digital/decentralized components across the study lifecycle
Serve as the study-level lead for digital medicine activities
Partner with clinical study teams to embed and operationalize digital strategies
Act as a key contributor in study planning discussions
bringing digital and DCT expertise
and oversight of digital health technologies and vendors
Ensure vendor solutions align with protocol requirements and patient experience considerations
Manage vendor performance
and delivery of milestones
Collaborate with clinical operations
Ensure digital components are fully integrated into broader study plans
Stay current on evolving decentralized trial methodologies and digital health technologies
Translate external trends into practical applications for study design and execution
Support adoption of innovative approaches within study teams
Communicate study design considerations
and execution updates clearly
Develop materials to support study teams and leadership discussions
Influence stakeholders on adoption of pragmatic and digital approaches at the study level
How You'll Work.
Team & Collaboration
Partner closely with study teams and Senior Managers (L6) to translate Digital Medicine strategy into fit-for-purpose study designs and operational plans.; Partner with clinical study teams to embed and operationalize digital strategies; Act as a key contributor in study planning discussions, bringing digital and DCT expertise; Collaborate with clinical operations, medical, regulatory, safety, and other functions; Communicate study design considerations, risks, and execution updates clearly; Develop materials to support study teams and leadership discussions; Influence stakeholders on adoption of pragmatic and digital approaches at the study level
Communication Scope
communication and stakeholder management ability to influence across levels and functions.; Communicate study design considerations, risks, and execution updates clearly; Develop materials to support study teams and leadership discussions
Process & Methodology
Manage timelines, deliverables, and performance of digital/decentralized components across the study lifecycle, Manage vendor performance, issue resolution, and delivery of milestones
Full Job Description
## **Career Category** Medical Affairs ## ## **Job Description** **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. Operations Manager, Digital Medicine The Operations Manager, Digital Medicine supports the study-level design and leads execution of digital medicine studies including digital components and integrating pragmatic and decentralized approaches into clinical trials. This role partners closely with study teams and Senior Managers (L6) to translate Digital Medicine strategy into fit-for-purpose study designs and operational plans. The Operations Manager ensures that digital health technologies and decentralized methodologies are effectively embedded within protocols and executed with operational excellence. The role represents a key bridge between strategy and delivery, with accountability for both study-level design input and execution. **LIVE** **What you will do** Key Responsibilities include: * Contribute to study design by integrating pragmatic and decentralized elements aligned with clinical and product strategy * Translate digital medicine strategy into actionable study-level plans, including selection of endpoints, technologies, and operational approaches * Provide input on protocol design, feasibility, and patient-centric approaches enabled by digital solutions * Ensure alignment between digital design elements and study objectives, endpoints, and regulatory considerations * Ensure successful implementation of decentralized trial elements (e.g., ePRO, wearables, remote monitoring, hybrid/virtual visits) * Manage timelines, deliverables, and
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