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#WeareBiotech
Clinical Scientist Associate Director – Autoimmune/Inflammation
Location
United States
Posted
99 days ago
Salary
$183.3K - $223.4K / year
Seniority
Senior
Job Description
Clinical Scientist Associate Director – Autoimmune/Inflammation
Amgen
• support late-phase clinical development by contributing to protocol development, study start-up, data review and monitoring and analysis activities • Working collaboratively with the study team and clinical leadership • focus on study-level implementation and cross-functional coordination to help ensure high-quality, decision-ready clinical data • 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 and 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.
Job 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
- Experience in Autoimmune or inflammation clinical development
- Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
- Industry or academic experience supporting late-phase drug development within a relevant therapeutic area or disease indication
- 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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