Full-Time Clinical Research Senior Medical Scientist

• Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the clinical development program.
• Participate and provide clinical input into safety and regulatory interactions.
• Provide clinical/scientific input during the development and execution of clinical trials.
• Review data from clinical trials related to medical monitoring, as well as support and address questions from sites and from investigators.
• As needed, provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols).
• Interpret clinical trial data and participate in safety assessments.
• Review and provide clinical scientific input to safety narratives.
• Initiate database analyses to support commercial/clinical objectives.
• Contribute to the preparation of clinical study reports and regulatory submissions.
• Support interactions with regulatory agencies if needed.
• Develop key opinion leaders and make scientific presentations at advisory boards, key scientific meetings, and external committee meetings as delegated by the GDL or delegee.
• Help identify new clinical research opportunities.

• Doctorate degree and 2 years of experience in clinical trials implementation in diabetes, obesity or metabolic diseases OR Master’s degree and 4 years of experience in clinical trials implementation in diabetes, obesity or metabolic diseases OR Bachelor’s degree and 6 years of experience in clinical trials implementation in diabetes, obesity or metabolic diseases OR Associate’s degree and 10 years of experience in clinical trials implementation in diabetes, obesity or metabolic diseases.
• Accredited residency in Endocrinology, board certified or equivalent.
• 2+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities. MD preferred.
• Prior research in diabetes, obesity or metabolic diseases preferred.
• An 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 and execution 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, especially in implementation of clinical trials while exhibiting superior judgment and balanced, realistic understanding of issues.

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