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Amgen Director, Observational Research in Thousand Oaks, California

Job Summary

Observational Research (OR) uses real-world evidence to make important contributions to drug development, commercialization, and safety evaluation. Observational Research contributes evidence regarding the frequency and distribution of disease, the natural history and clinical burden of disease, the design of clinical trials, cost and utilization patterns, and the safety and effectiveness of therapies. There is increasing demand for information from OR studies by regulatory and reimbursement authorities. The Center for Observational Research (CfOR) was created to address this imperative.

The Director - Center for Observational Research champions strategies that impact project team and the Center. The Director is recognized as a major scientific contributor and is frequently a first or contributing author for papers in peer reviewed journals or for internal reports that enhance Amgen’s mission. The Director leads, manages and coordinates observational research products within therapeutic areas and is responsible for making significant contributions to scientific direction of products, researching initiatives and developing Center research programs. The Director will improve design of clinical research programs and anticipate and evaluate clinical benefit and safety issues both pre and post-approval. The director will:

  • Conduct research to the highest standards of the profession

  • Align research with project team strategies

  • Provision the highest quality observational research advice and training within Amgen

  • Participate in initiatives to improve capabilities of the Center

  • Contribute to the development of research strategies with project teams and the Center

  • Conduct high-quality observational research to support project team strategies

  • Contribute to the development of product and Center TA strategies

  • Collaborate on patient exposure update and safety studies

  • Contribute to the development and implementation of post approval safety studies

  • Contribute to the development of staff within the Center

  • Develop and maintain relationships with key leaders in observational research

  • Contribute to the setting of project and professional development goals

  • Provide input into Center meetings

  • Stay abreast on the latest developments in observational research, safety surveillance and drug development and contributes to the field

  • Promote observational research awareness

  • Promote understanding and use of state-of-the-art observational research methods

  • Communicate significant scientific information to a variety of audiences

  • Assist in hiring, managing, mentoring and developing staff

Basic Qualifications

Doctorate degree and 4 years of Epidemiology Observational Research experience

OR

Master’s degree and 7 years of Epidemiology Observational Research experience

OR

Bachelor’s degree and 9 years of Epidemiology Observational Research experience

Preferred Qualifications

  • Doctorate in Epidemiology or subject with high epidemiologic content or Medical and master’s degree in Epidemiology or subject with high epidemiologic content

  • 3 years experience with Medical degree or 5 years experience with Doctoral degree

  • Experience in the design, execution and analysis of observational research studies within Pharmaceutical or Public Health settings

  • Clinical research experience

  • Experience in research to support drug development

  • Experience in observational research project planning and management

  • Experience communicating observational research information

  • Record of publication in top tier epidemiology or clinical journals

  • Programming in SAS or other software (e.g. STATA)

  • Advanced knowledge of epidemiology methodology, drug development applications and observational research databases

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.

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.

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