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Clinical Research Sr Medical Scientist - Oncology Thousand Oaks United States,
Posted on : 01 May 2017
This Role 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 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 opportunitiesKnowledge:- Understanding of the scientific method and clinical applications based on medical, scientific and practical rationale- Familiarity with concepts of clinical research and clinical trial design, including biostatistics- Medical knowledge in the relevant therapeutic area- Sound scientific and clinical judgment- 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 a balanced, realistic understanding of issuesBasic Qualifications: - MDPreferred Qualifications:- MD plus accredited fellowship in relevant sub-specialty, board certified or equivalent- Two (2) or more years of clinical research experience and/or basic science researchAmgen 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.
US, California, Thousand Oaks
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