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Clinical Research Medical Director - Bone (Prolia)

Company: Amgen
Location: Thousand Oaks
Posted on: May 19, 2019

Job Description:

Amgen's Clinical Development organization is hiring a Clinical Research Medical Director in Bone Therapeutic Area in Thousand Oaks, CA.Key Responsibilities include:

  • Support the design, assessment, and communication of clinical programs that support the global scientific/medical evidence plan
  • Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
  • Participate in and provide clinical input into safety and regulatory interactions
  • Provide clinical/scientific input during the development and execution of clinical trials
  • Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols)
  • Interpret clinical trial data
  • Participate in safety assessments
  • Review and provide clinical scientific input to TLGs and safety narratives
  • Review scientific literature
  • Initiate database analyses to support commercial/clinical objectives
  • Contribute to the preparation of clinical study reports and regulatory submissions
  • Participate in interactions with regulatory agencies
  • Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the Clinical Scientists, NAML, or GDL
  • Identify new clinical research opportunitiesBasic Qualifications MD/DO degree from an accredited medical school OR PhD OR PharmDAND2 years of clinical research experience and/or basic science researchPreferred Qualifications
    • Accredited training in Internal Medicine, Rheumatology or Endocrinology, board certified or equivalent
    • 2+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
    • An understanding of the scientific method and clinical applications based medical, scientific and practical rationale
    • Familiarity with concepts of clinical research and clinical trial design including biostatistics
    • Familiarity with regulatory agency organizations, guidelines, and practices
    • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
    • History of solving problems while exhibiting superior judgment and balanced, realistic understanding of issuesWe understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.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.MD01#LI-POST

Keywords: Amgen, Los Angeles , Clinical Research Medical Director - Bone (Prolia), Executive , Thousand Oaks, California

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