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 read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. SENIOR GLOBAL TRIAL MANAGER Using clinical trial management knowledge and experience in the drug development industry, the Senior Global Trial Manager (SGTM) will lead a global cross-functional team to successfully deliver high quality results on time and within budget. A professional in study management will play a critical role in delivering Amgen’s Global Clinical Trial portfolio within a fast paced and collaborative environment. LIVE What you will do In this vital role you will be responsible for leading the successful delivery of our exciting and innovative clinical trial portfolio on time and within budget, in accordance with quality standards. No day will be the same and you will be at the forefront of innovative drug development. Amgen’s product pipeline covers many Therapeutic areas, including: Oncology, Haematology, Bone, Neuroscience, Inflammation, Cardiovascular, Rare Disease, Obesity and Observational Research. Leader of the cross-functional Clinical Study Team. Input operational expertise into the study design process. Lead and manage the operational strategy and execution of clinical trials from study design through to close out at a global level, ensuring the quality and scientific integrity of the trial in a Risk-Based Study Execution model Line Management of Global Trial Managers and Local Trial Managers Oversight of and close collaboration with study team members as well as cross functional stakeholders, through effective communication and proactive identification of opportunities as well as risks, management and mitigation to ensure timely and on-budget execution of clinical trial deliverables Leading the Clinical Study Team to drive effective decision making Maintaining global business relationships cross-functionally and communicating global status of clinical trial to senior management as needed/required Ensuring the conduct of studies in accordance with Regulatory Authorities, company SOPs and ICH-GCP guidelines including Trial Master File (TMF) Management. Ensuring inspection readiness at all times. Perform risk assessment and develop risk mitigation strategies to support study delivery Effective management of vendors to the required standards Lead/support global process development and improvement activities Travel as required to support the execution of clinical studies Be part of our team You would be joining a team where we are building upon our foundation and long-term commitment to patients by developing a whole new class of novel molecules across multiple therapeutic areas – and we need top talent to ensure these molecules become medicines and realize their potential for helping patients. The team is responsible for delivering Amgen’s Global Clinical Trial portfolio, in a fast-paced, highly innovative and collaborative environment. The SGTM role sits in the Clinical Program Operations (CPO) function, alongside our team of Global and Local Trial Managers responsible for clinical trial delivery at the global/local level. The SGTM reports into the Clinical Program Manager role. 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 Extensive global clinical project management experience, including global level leadership of multiple phase 2 or 3 clinical trials Ability to effectively manage multiple priorities and to thrive in a fast-paced environment Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.) Broad experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company) Knowledge of time, cost and quality metrics, Key Performance Indicators (KPIs) Experience in innovative trial design, adaptive trial design is preferred but not essential 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 flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. Application close date: 25th October 2024 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, 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. .