Development Feasibility Manager

Career Category

Clinical

Job Description

DEVELOPMENT FEASIBILITY MANAGER

Responsibilities

• Manage 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 stakeholders on country capability
• Provide local input into study risk identification
• Drive local feasibility
• Develop Country Operational Plan
• Advise on final site selection
• 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 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 GCPM representatives to provide local country landscaping data for inclusion into the program and study design and to inform/support study placement, as applicable
• Support selection for sites within the country(ies) 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 obtain input on proposed study design (Study Design Optimization) and GCPM representatives to analyze local feedback for incorporation into study design and operational planning decisions
• 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

Qualifications

Basic Qualifications

• BA/BS/BSc or qualified nurse (RN)

Public Information

• 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)

Competencies

• Approachable and trustworthy, builds constructive and effective relationships.
• Strong Communication skills (written & oral). Presents confidently in a variety of settings, adjusting to audience and bringing message across.
• Communicates pro-actively keeping internal and external stakeholders updated.
• Ability to work effectively across teams and on multiple projects
• Capable of influencing within and operating through a complex global matrix.
• Effective relationship building and stakeholder management skills across functions, regions and cultures.
• Demonstrated ability to work independently
• Robust analytical ability

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