• Job Description

  Req#: R-167393

  Career Category

  Clinical

  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.

  LIVE – What you will do

  Let’s do this. Let’s change the world. In this new and vital role, you will develop, implement and maintain coordinated site engagement and operations at key/targeted sites, support global study strategy plan to accelerate development of marketed and early pipeline products. You’ll also maintain an effective collaborative partnership with all stakeholders, ensuring aligned and synergistic approach to sites’ Amgen experience.

  Key Responsibilities:

  Leadership of Operational Site Engagement

  • Align and lead identification and strategic partnership with key sites to implement a collaborative initiative for clinical trials

  • Accountable for strategic long-term operational partnerships with key sites, provide local intelligence

  • Proactive and accountable to drive expansion of Amgen’s strategic relationships and meet clinical operational needs

  • Primary site-facing, cross-study, operational decision-maker between Amgen and designated key sites to establish Amgen-Institutional operational working practices

  • Maintain country expertise, site knowledge to navigate with Amgen and sites with targeted and tailored communication

  • Develop, drive and monitor site operational strategies and performance across all therapeutic areas and studies, in strong collaboration with Amgen stakeholders

  • Assimilate and report external feedback to evaluate and propose operational process efficiencies, focus and direction for site collaboration on clinical trials

  • Orchestrate relationship management and strong internal alignment with Amgen stakeholders (medical, study management, site management, and other key -stakeholders) to drive operational efficiencies

  Locally accountable for key, targeted sites execution of clinical studies

  • Build and develop strong relationships with key sites to engage with Amgen as choice for clinical trial participation

  • Regular communication with key sites to connect on all trials/all stages to determine trends and opportunities and enhance sites’ Amgen experience

  • Maintain access to key sites’ leadership & operation teams, point of escalation for potential barriers and operational issues

  Global Site Operations Quality Management

  • Actively participate in role forums including local/global functional and cross functional initiatives

  • Participate in Functional Management Team Meetings as required and applicable country-level project review meetings

  WIN – What we expect of you

  We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a hardworking team player with these qualifications and experience:

  • Relevant tertiary qualifications

  • Experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)

  • Expertise and in-depth understanding of site engagement with clinical trials, or building and/or coordinating community research networks

  • In depth understanding of drug development process, clinical trial conduct, ICH-GCP and local regulations, requirements, and guidelines

  • Project and Program management including oversight of quality, study deliverables, budgets and timelines

  • Fluency in English, both oral and written communication

  • Clinical trial management systems and reporting tools and utilization of Key Performance Indicators (KPIs)

  THRIVE – What you can expect from us

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

  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plan—comprising finance and wealth, work/life balance, and career benefits

  • Generous Total Rewards Plan—comprising finance and wealth, work/life balance, and career benefits

  .

• About the company

  Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

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