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Role Description
In this vital role you will support the design, assessment, and communication of clinical programs which support the global scientific/medical evidence plan.
- 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.
Qualifications
- 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.
Requirements
- 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.
Benefits
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
- Stock-based long-term incentives.
- Award-winning time-off plans and bi-annual company-wide shutdowns.
- Flexible work models, including remote work arrangements, where possible.
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