Clinical Scientist Director – Late Development, Rare Disease
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Job Description
Clinical Scientist Director managing late-phase clinical development at Amgen. Supporting scientific and clinical strategy translation into actionable execution across clinical trials.
Responsibilities:
- Support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials
- Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity.
- Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
- Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects.
- Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results.
- Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements.
- Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.
- Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues.
- Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle.
- Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams.
Requirements:
- Doctorate degree and 4 years of clinical development experience OR Master’s degree and 7 years of clinical development experience OR Bachelor’s degree and 9 years of clinical development experience
- 5 years of pharmaceutical clinical drug development experience
- Strong preference for individuals with proven track record of clinical trial process improvement
- Industry or academic experience in late-phase drug development for Inflammation Development Therapeutic Area.
- Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral)
- Experience with designing, monitoring, and implementing clinical trials for the Inflammation Development Therapeutic Area and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
- Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data
- Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
- Serving as a contributing author to scientific publications and data presentations at scientific conferences
- Experience in clinical data analysis such as Spotfire or other data analysis tools.
Benefits:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- 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
- Flexible work models where possible.
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