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Development Feasibility Manager

Company: Amgen
Location: Newbury Park
Posted on: August 18, 2019

Job Description:

The Global Study Operations (GSO) team's vision is to be best in class for execution of clinical trials; gathering patient insights, utilizing data analytics, developing innovative solutions & technology to deliver quality clinical data.The mission is to deliver quality clinical trials through industry-leading execution of innovative processes, strong cross-functional partnerships, and best-use of clinical systems and analytics to guide site and study operations.Through effective partnerships and collaborations, GSO contributes to Amgen's mission by delivering high quality data to support the Amgen pipeline and product portfolio, to create shareholder value and serve patients. We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.The Development Feasibility Manager responsibilities:

  • Management of local feasibility
  • Inform on country capability
  • Drive Targeted local feasibility
  • Deliver local information into study design planning
  • Develop local strategy for operational plan
  • Drive Voice of Patient and Voice of Site data collection, as applicable
  • Drive local patient recruitment and retention strategies
  • Partner with Operational Feasibility Senior Managers (OFSMs)
    • Build internal/external stakeholder engagement aiming at identifying new investigators and maintaining relationship with and knowledge of current investigators in alignment with Amgen's product clinical development plans
    • Develop repository of local site intelligence information (Country Landscaping) to support operational delivery (eg, site capabilities, performance, regulatory landscape, treatment patterns etc)
    • Identify and contract with Reference Sites in support of local landscaping
    • Understand local outreach and patient referral pathways in support of global/local operational delivery
    • Develop and maintain knowledge of external local clinical trial environment and assess developments for impact on study design and execution (Horizon Scanning)
    • Partner with Global Feasibility Operations Director (GFOD) and Development Design Center (DDC) to provide local country landscaping data for inclusion in the Evidence Generation Plan and study design as applicable
    • Engage with local reference sites to obtain input on proposed study design (Study Design Optimization) as requested by GFOD/DDC and partner with GFOD to analyze local feedback for incorporation into study design and operational planning decisions
    • Support operating reviews by monitoring predictability and delivery, and perform refinements required to local site intelligence data
    • Use site intelligence and local cross-functional input for study-level operational planning in support of validation of country commitment for a study
    • Ensure consistency of activities and development of best practices through leadership / participation in Global Development Feasibility Manager forumBasic Qualifications:Doctorate degreeORMaster's degree and 3 years of clinical experienceORBachelor's degree and 5 years of clinical experienceORAssociate's degree and 10 years of clinical experienceORHigh school diploma / GVP and 12 years of clinical experiencePreferred Qualifications:
      • BA/BS/BSC in the life sciences or RN
      • 7+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical research experience (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 of local country and international clinical trial management (including regulations & guidelines)
        • Approachable and trustworthy, 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 abilityOur culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.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.Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.Join UsIf 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.

Keywords: Amgen, Los Angeles , Development Feasibility Manager, Executive , Newbury Park, California

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