Development Feasibility Manager

hace 2 semanas

Xico, México Amgen A tiempo completo

**Transforming Patient Lives through Strategic Clinical Trial Delivery**

At Amgen, we're committed to serving patients worldwide. As a Development Feasibility Manager, you'll play a crucial role in supporting our global study design, country and site selection, and clinical trial delivery excellence.

**Key Responsibilities:**

  • Lead 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 customers 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.
  • 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 seeking at identifying new investigators and managing relationship with authorities 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 advise/support study placement, as applicable.
  • Support selection for sites within the country(ies) to participate in a study based on information captured 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 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.

**What We Expect of You:**

We're looking for a professional with a Doctorate degree or equivalent experience in life sciences or a medically related field. You should have a strong background in clinical research, preferably in a biotech, pharmaceutical, or CRO company. Proficiency in English is a must.

**Preferred Qualifications:**

BA/BS/BSc in life sciences, clinical trial management experience, international collaboration, and operational performance measurement experience are highly desirable.

**Competencies:**

We're looking for someone with excellent communication skills, approachability, and honesty. You should be able to build effective relationships and work collaboratively with internal and external stakeholders.

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