Amgen Job Openings – Development Feasibility Manager

Job Description:

• In our mission to serve patients, speed is absolutely critical. We’re rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team – working toward our mission of advancing high potential programs for cancer patients around the world.
• As the Development Feasibility Manager you will be responsible for develop and maintain the local landscape knowledge in line with the Global Development pipeline to support strategic global study design and excellence in clinical trial delivery.

Job Responsibilities:

• 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 analyze local feedback for incorporation into study design and operational planning decisions
• 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.)
• Ensure consistency of activities and development of best practices through leadership / participation in Development Feasibility Manager Forum
• 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
• Act, on request, as DFM – POC, coordinating and analyzing the COLA outputs and sharing these with GCPM
• Develop and maintain knowledge of external local clinical trial environment and assess impact on study design and execution
• Support operating reviews by analyzing COLA participation and outcomes, predictability and delivery
• 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.
• Use site intelligence and local cross-functional input for study-level operational planning in support of country commitments validation and potential site list identification
• Identify and contract Reference Sites in support of local landscaping
• Build internal/external stakeholder engagement aiming at identifying new investigators and maintaining relationship with experts in specific therapy areas

Qualification & Experience:

• 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)
• BA/BS/BSc or qualified nurse (RN)
• 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

Job Details:

Company: Amgen

Vacancy Type:  Full Time

Job Location: Los Angeles, CA, US

Application Deadline: N/A

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