Digital Medicine Operations Manager
Job Summary
Career Category
Medical AffairsJob Description
HOW MIGHT YOU DEFY IMAGINATION
If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its 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 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
Lead evaluation selection and oversight of digital health technologies and vendors
Ensure vendor solutions align with protocol requirements and patient experience considerations
Manage vendor performance issue resolution and delivery of milestones
Collaborate with clinical operations medical regulatory safety and other functions
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 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
Be part of our team
You would be joining a dynamic successful and cohesive team dedicated to achieving results continuously exploring innovative approaches to success all while ensuring the delivery of the best medicines to benefit patients.
WIN
What we expect of you
Basic Qualifications:
Doctorate degree and 4 years of relevant experience OR
Masters degree and 7 years of relevant experience OR
Bachelors degree and 9 years of relevant experience
Preferred Experience
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.
Strong communication and stakeholder management skills; ability to influence across levels and functions.
Post Marketing / Phase 4 experience
for a career that defies imagination
In our quest to serve patients above all else Amgen is the first to imagine and the last to doubt. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
.Required Experience:
Manager
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more