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Site Management Development Feasibility Manager
2 semanas atrás
**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.
**What you will do**:
Let’s do this. Let’s change the world. In this vital role you will interact with healthcare decision makers to communicate and advance the scientific platform as aligned with Amgen’s corporate goals and objectives
**Site Management Development Feasibility Manager**:
Develop and maintain the local therapeutic landscape knowledge in line with the Global
Development pipeline to support strategic global study design, country and site selection and excellence in clinical trial delivery.
**Responsibilities**:
- Run indication and study operational insight into treatment landscape at a country level
- Validate global data on country capability and potential site identification
- Engage with and inform partners on country capability
- Provide local input into study risk identification
- Drive local feasibility
- Develop Country Operational Plan
- Advise on final site selection
- Drive Voice of Patient and Voice of Site data collection, as applicable
- Develop and maintain knowledge of external local clinical trial environment and assess impact on study design and execution
- Develop and maintain repository of Country Landscaping information Country Site Intelligence Tool to support operational delivery (eg, site capabilities, performance, regulatory landscape, treatment patterns etc)
- Develop expertise and understanding of local country availability and clinical use of biomarkers and other -omics data which may impact key Amgen products and development programs
- Build internal/external partner engagement aiming at identifying new investigators and maintaining relationship with experts in specific therapy areas Understand patient flows and referral pathways in support of global/local operational delivery
- Partner with GCPM representatives to provide local country landscaping data for inclusion into the program and study design and toadyism/support study placement, as applicable
- Support selection for sites within the country to participate in a study based on information gathered through feasibility.
- Identify and contract Reference Sites in support of local landscaping
- Engage with local reference sites in collaboration with local medical team to acquire input on proposed study design (Study Design Optimization) and GCPM representatives to analyses local feedback for incorporation into study design and operational planning decisions
**Basic Qualifications**:
- BA/BS/BSc or qualified nurse (RN)
- Experience of working in life sciences or medically related field, including biopharmaceutical clinical research experience clinical research experience acquired working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting biotech.
**Preferred Qualifications**:
- BA/BS/BSc in life sciences
- Master’s degree, M.D., PharmD
- Broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience acquired working on clinical trials in a biotech, pharmaceutical or CRO company
- Clinical trial management experience
- Operational performance measurement experience
- International collaboration experience
**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.
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**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.
**Join Us**:
If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.
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