Development Feasibility Mgr

hace 2 semanas

Ciudad de México, Ciudad de México Amgen A tiempo completo

HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. We have proudly achieve certifications as
Great Place to Work and
Equidad MX. It's time for a career you can be proud of.
Join us.

Development Feasibility Manager

Live

What you will do
Let's do this.

Let's change the world The Development Feasibility Manager Develop and maintain the local therapeutic landscape knowledge in line with the Global Development pipeline to support strategic global study design, country and site selection and excellence in clinical trial delivery.


Responsibilities

Key responsibilities include, but are not limited to:

  • 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.
  • Driving local feasibility.
  • Develop Country Operational Plan.
  • Advise on final site selection.
  • Drive Voice of Patient and Voice of Site data collection, as applicable.
  • Developing and maintain knowledge of external local clinical trial environment and assess impact on study design and execution.
  • Developing 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 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 crossfunctional input for studylevel 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.

Win

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications.

Basic Qualifications:

  • Doctorate degree OR
  • Master's degree and 3 years of working in life sciences or medically related field, including biopharmaceutical clinical research experience working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting Or
  • Bachelor's degree and 5 years of working in life sciences or medically related field, including biopharmaceutical clinical research experience working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting experience.
  • Associate's degree and 10 years of working in life sciences or medically related field, including biopharmaceutical clinical research experience working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting experience Or
  • High school diploma / GED and 12 years of working in life sciences or medically related field, including biopharmaceutical clinical research experience working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting experience.
  • Proficiency in English, both in written and verbal communication.

Preferred Qualifications:

  • BA/BS/BSc in life sciences.
  • Clinical trial management, international collaboration and Operational performance measurement experience.
  • Knowledge of local country and international clinical trial management (including regulations & guidelines)

Competencies:

  • Approachable and honest, builds and effective relationships.
  • Good Communication skills (wr

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