Director & Regional Head Clinical Site Management

Career Category

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.

DIRECTOR & REGIONAL HEAD CLINICAL SITE MANAGEMENT

LIVE

What you will do

In this vital role you will lead and manage the Site Management operations activities in assigned European countries. You will assess and determine regional contribution to feasibility, study placement, subject recruitment, and monitoring functions within GSO in support of Amgen-sponsored clinical trials whilst ensuring adherence to Amgen standards and all applicable regulations

Responsibilities:

• Build and maintain Amgen capabilities for clinical trial conduct in the region
• Subject matter expert, single point-of contact and escalation route for assigned Global Study Operations (GSO) operating region including contribution to functional strategic direction
• Ensure timely, high-quality data from Amgen-sponsored clinical trials in the region
• Budgeting and resourcing for the assigned countries & oversee management of Functional Service Providers (FSP)
• Promote operational excellence to ensure quality, compliance, efficiency, and ensure delivery to commitments in study execution
• Promote innovation and support global and functional initiatives where appropriate including global alignment within GSO, Global Development Operations (GDO) and Therapeutic Areas (TA)
• Facilitate the sharing of best practices and lessons learned in the region/countries
• Advise on study placement through cross-functional collaboration with GDO and TAs
• Accountable for selection of FSP vendor(s) within the region supporting monitoring activities
• Support regional/country oversight activities of FSP vendor(s)
• Works with Country/Regional Medical Director(s) to hire and manage DOMs and contribute to their career development

Be part of our team

Sitting within Global Development Operations, Global Study Operations – Site Management’s mission is to seamlessly execute trials by partnering with clinical sites, vendors and internal stakeholders to rapidly deliver quality data in service of patients.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

• Degree educated or equivalent
• Extensive 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
• Experience at, or oversight of, outside clinical research vendors (CRO’s, central
• In-depth understanding of drug development process, clinical trials conduct, ICH- GCP guidelines and FDA regulations
• Regional expertise
• Cross-cultural knowledge
• Finance and budgeting
• Detailed understanding of customer service as it applies to clinical research
• Extensive understanding of project management principles and implementation
• Familiarity with speed, productivity, cost and quality metrics

THRIVE

What you can expect of us

As we work to develop treatments that take care of others, so we 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

LOCATION Ability to work fully remotely

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.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, 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.