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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.

Clinical Site Management Oversight Sr. Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be a Country/hub Co-leader of Global Study Operations / Site Management (GSO-SM) Organization that is accountable for timely, quality clinical study delivery. As well as actively partnering with cross-functional stakeholders to support R&D strategy.

The focus of this role will be on driving improvement, optimization and consistency in the areas of study conduction and close out, which are critical to United States performance and delivery. This role will have direct oversight of the CRA CTOM team.

Responsibilities

• Co-Leadership of GSO-SM team in country/hub, as delegated by the DOM
• Align and co-lead country/hub in accordance with Amgen strategy, driving «One Amgen» *
• Supporting-leading local and global process improvement & transformational initiatives
• Represent GSO-SM in internal and external stakeholder interactions
• Participate in external engagement activities (e.g. pharma associations, Consortiums)
• Point for escalation for resolution of complex clinical study related issues & risks identified
• Risk mitigation and quality management
• Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness
• Interpret analytics to monitor clinical study delivery (timelines, enrollment, data flow, TMF)
• Oversee quality and ensure country/hub deliverables in accordance with ICH-GCP, Amgen standards and Local Regulations
• Support inspection readiness, internal/affiliate and site audits and regulatory inspections, including CAPA resolution
• Actively participates cross-functional initiatives
• Leads local process improvement initiatives
• Performance management of local staff and oversight of GSO-SM Functional Service Provider(s) (FSP) (may only apply to specific local GSO-SM roles as delegated by the DOM)
• For applicable roles, primary point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues
• Partner with DOM and SM-FSP line management to maintain appropriate resource levels and manage within budget
• Ensure efficient resource allocation for applicable local GSO-SM roles
• Supports SM-FSP staff onboarding and training
• Locally accountable for execution of clinical studies
• Support local delivery of pipeline molecule programs
• Performs sponsor oversight activities of SM-FSP, including capacity planning and management, staff training and performance, to ensure quality and delivery of Amgen clinical trials, as outlined in quality oversight plan
• Ensure timely, quality communication to both functional / cross-functional teams to support clinical study execution
• Partner with GSO-SM FSP and GCPM organization to monitor study progress and drive local action plans & issue resolution
• Provide local expertise through tools or upon request
• Engage local cross-functional teams to maximize local support of clinical studies
• Maintain relevant therapeutic knowledge and clinical research best practices
• Provide information and request support as needed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a driven leader with these qualifications.

Basic Qualifications

• Doctorate degree and 2 years of work experience in life sciences or medically related field or
• Master’s degree and 5 years of work experience in life sciences or medically related field or
• Bachelor’s degree and 7 years of work experience in life sciences or medically related field
• Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
• Previous management experience of direct reports, including management level staff

Preferred Qualifications

• M.D., D.O., PhD, PharmD, Master’s Degree
• Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
• Country clinical operations experience and/or regional study management experience

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

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.

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