Career Category

Medical Affairs

Job Description

•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) •Build internal/external stakeholder 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 OFSMs and GCPM representatives to provide local country landscaping data for inclusion into the program and study design and to inform/support study placement, as applicable •Select the sites (support selection for sites in Early Development studies) within the country(ies) to participate in a study based on information gathered through COLA and site evaluation process. •Identify and contract Reference Sites in support of local landscaping •Engage with local reference sites in collaboration with local medical team to obtain input on proposed study design (Study Design Optimization) and partner with OFSMs and GCPM representatives to analyse local feedback for incorporation into study design  and operational planning decisions•Support operating reviews by analysing COLA participation and outcomes, predictability and delivery•Use site intelligence and local cross-functional input for study-level operational planning in support of country commitments validation and potential site list identification•Ensure consistency of activities and development of best practices through leadership / participation in Development Feasibility Manager Forum•Act, on request, as DFM – POC, coordinating and analysing the COLA outputs and sharing these with GCPM

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 obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)

Preferred Qualifications 

•BA/BS/BSc in life sciences•Masters Degree, M.D., PharmD •Broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company•Clinical trial management  experience•Operational performance measurement experience•International collaboration experience

Knowledge

•Knowledge of local country and international clinical trial management (including regulations & guidelines)

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 disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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