Amgen Development Feasibility Mgr in Mexico City, Mexico
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
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.
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 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 are all different, yet we all use our unique contributions to serve patients. The professional we seek has these 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.
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)
Approachable and honest, builds and effective relationships.
Good 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 customers updated.
Ability to work effectively across teams and on multiple projects.
Capable of influencing within and operating through a sophisticated global matrix.
Effective relationship building and team member leadership skills across functions, regions, and cultures.
Demonstrated ability to work independently.
Robust analytical ability.
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Full support and career-development resources to expand your skills, improve your expertise, and maximize your potential along your career journey.
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor.
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.