Development Feasibility Mgr - Singapore - Amgen

Description

Development Feasibility Manager

Singapore

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Development Feasibility Manager in Singapore .

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What you will do

Reporting to the Development Operations Senior Manager, you will play a key role in ensuring that we are keeping our finger on the pulse externally within the clinical trial environment and that we our clinical operations teams are up to date with all the vital information to position Amgen at the forefront of the market across the SEA region.

Key Responsibilities

• Develop and maintain knowledge of external clinical trial environment and assess impact on study design and delivery in SEA Hub

• Develop and maintain repository of Country Landscaping information (Country Site Intelligence Tool) to support operational delivery (e.g., site capabilities, performance, regulatory landscape, treatment patterns etc.) in SEA Hub

• 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 targeted at identifying new investigators and managing relationship with experts in specific therapy areas

• Understand patient flows and referral pathways in support of global/local operational delivery

• Partner with global feasibility manager and global project management representatives to provide country landscaping data in SEA Hub for inclusion into the program and study design and to guide study placement, as applicable

• Select the sites strategically in SEA Hub to be involved in a study based on information captured through medical and operational assessment

• Use site intelligence and local cross-functional input for study-level operational planning in support of country commitments validation and potential site list identification in SEA Hub

• Ensure consistency of activities and development of best practices through leadership / participation in Global Development Feasibility Manager Forum

• Coordinate and analyze global/regional feasibility outputs and sharing these with global project management group

Qualifications and Knowledge

• BA/BS/BSc in life sciences

• Masters Degree, M.D., PharmD preferred

• Regional clinical trial management experience

• Regional operational performance measurement experience

• International collaboration experience

• Broad work experience in life sciences or medically related field, including clinical research experience in a biotech, pharmaceutical or CRO company

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