Global Feasibility Manager

Career Category Clinical Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Global Feasibility Manager What you will do Let’s do this. Let’s change the world. In this vital role you will will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Live What you will do Let’s do this. Let’s change the world. In this vital role you will own the development and execution of the feasibility strategy in partnership with clinical program team, study delivery team, global study management, and cross- functional data teams to deliver a fully-optimized operational action plan. You will lead the successful delivery of the feasibility process (strategy plans, country selection, site identification, timelines, synthesis of feasibility insights) to expedite cycle times for all clinical programs assigned. Lead activities pertaining to country and site identification, feasibility and country selection within a clinical study Partner with study team members, data analytics team, and country teams to design and conduct global feasibility activities on time with high quality delivery. Ensure consistency of feasibility execution across the portfolio/pipeline including bridging gaps between local/central data Ensure clear timelines and expectations are aligned and communicated between data providers and study teams to expedite data insight deliverables and confirm the analysis timeline is coordinated with study team decision milestones. This includes initial enrollment timelines, footprint optimization, developing key assumptions, and establishing patient recruitment strategy potential, etc. Lead the collection of local internal and external data (e.g. local treatment standard of care, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to targeted patient population, operational barriers) to define an optimal geographic country footprint and proposed sites for participation in a clinical study. In partnership with internal partners- synthesize, interpret and integrate data and information to provide clear feasibility recommendations to further embed data-driven decision making, analyze trends, identify root causes, and provide actionable recommendations across study teams and programs to accelerate study execution. Facilitate the study baseline commitment & change process (country and study levels). Initiate and lead global feasibility continuous improvement efforts and initiatives. Support development of systems, processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility (country, site) as well as the timing of key recruitment achievements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a manager with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree & 2 years of directly related experience or equivalent, OR Bachelor’s degree & 4 years of directly related experience or equivalent, OR Associate’s degree & 8 years of directly related experience or equivalent, OR High school diploma / GED & 10 years of directly related experience Preferred Qualifications: 10+ years’ work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical, or CRO company Feasibility experience and/or country clinical operations experience Understands how data and analytics can inform study design and operational planning What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disabili