Clinical Research Sr Medical Scientist, Cardiology
Location:
Thousand Oaks , California
Posted:
February 07, 2017
Reference:
R-33176
The Clinical Research Sr. Medical Scientist is responsible for:
Supporting the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan
Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
Participating and providing clinical input into safety and regulatory interactions
Provide clinical/scientific input during the development and execution 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 opportunities
BASIC QUALIFICATIONS:
M.D. degree
PREFERRED QUALIFICATIONS:
Accredited fellowship in Cardiology, 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 organization, 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 issues
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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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