Associate Director, Clinical Scientist – Late Development, Obesity Therapeutic Area
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Job Description
Clinical Scientist Associate Director supporting late-phase clinical development with a focus on data quality at Amgen. Collaborating on clinical trials and ensuring high-quality clinical data results.
Responsibilities:
- Support set up and execution of late phase clinical trials with a focus on data quality
- Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
- Provide input into & implementation of data management plan, CRF design, and data review oversight
- Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
- Assists Development Lead and Clinical Scientist Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
- Anticipate and actively manage problems across a broad spectrum of cross-functional teams
- Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
- Support appropriate training, recruitment, and development requirements for matrix team resources
Requirements:
- Doctorate degree and 3 years of clinical development experience OR Master’s degree and 5 years of clinical development experience OR Bachelor’s degree and 7 years of clinical development experience OR Associate’s degree and 12 years of clinical development experience OR High school diploma / GED and 14 years of clinical development experience
- 3 years of pharmaceutical clinical drug development experience
- Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
- Industry or academic experience supporting early or late-phase drug development within a relevant therapeutic area or disease indication
- Strong communication and presentation skills, with the ability to clearly convey scientific concepts and clinical data to cross-functional teams and leadership audiences, both written and oral
- Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
- Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs
- Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance
- Experience serving as a contributing author on scientific publications or data presentations for internal forums or 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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