12 days old

Development Feasibility Manager

Amgen
Thousand Oaks, CA 91360
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  • Job Code
    124797782
Amgen

Job ID: R-105912
Location: Thousand Oaks, CA, US

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

In our mission to serve patients, speed is absolutely critical. We are rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team - working toward our mission of advancing high potential programs for cancer patients around the world.

As the Development Feasibility Manager, you will be responsible for develop and maintain the local landscape knowledge in line with the Global Development pipeline to support strategic global study design and excellence in clinical trial delivery. Main responsibilities are:
  • Management of indication and study operational landscaping at a country level
  • Inform stakeholders on country capability
  • Provide local input into study risk identification and mitigation
  • Drive Targeted local feasibility
  • Set up local country commitments and timelines
  • Develop Country Operational Plan
  • Drive Voice of Patient and Voice of Site data collection, as applicable
  • Drive local patient recruitment and retention strategies
  • Take on DFM POC role to coordinate and support COLA execution and analysis across the countries


Key Activities:

  • 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.)
  • 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 OFSMs and GCPM representatives to provide local country landscaping data for inclusion into the program and study design and to inform/support study placement, as applicable
  • Select the sites (support selection for sites in Early Development studies) within the country(ies) to participate in a study based on information gathered through COLA and site evaluation process.
  • 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 partner with OFSMs and GCPM representatives to analyze local feedback for incorporation into study design and operational planning decisions
  • Support operating reviews by analyzing COLA participation and outcomes, predictability, and delivery
  • 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 standards methodologies through leadership / participation in Development Feasibility Manager Forum
  • Act, on request, as DFM - POC, coordinating and analyzing the COLA outputs and sharing these with GCPM


Basic Qualifications

  • BA/BS/BSc or qualified nurse (RN)
  • Experience of working in life sciences or medically related field, including bio-pharmaceutical 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 bio-pharmaceutical 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 credible, 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


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, as well as work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen!

Amgen provides a comprehensive Total Rewards Program designed to enhance the long term financial, physical, and overall well-being of our staff and their families. We offer competitive compensation, long term incentive opportunities, generous paid time off, 401k, medical, dental and vision just to name a few.

As an organization dedicated to improving the quality of life for people around the world, Amgen champions 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.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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 crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join Us

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 disease, 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.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.



PI124797782
Posted: 2020-10-13 Expires: 2020-11-14

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Development Feasibility Manager

Amgen
Thousand Oaks, CA 91360

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