Clinical Research Coordinator managing the conduct of clinical trials at Emory University. Handling administrative activities and overseeing research project requirements and compliance.
AM
Hybrid Clinical Scientist Associate Director – Late Development, Oncology
Posted 2 weeks ago
About the role
- Associate Director supporting clinical development at Amgen for late-phase oncology trials. Focus on data quality, protocol development, and cross-functional coordination in healthcare innovation.
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 Medical Sciences 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 life sciences/healthcare experience OR Master’s degree and 5 years of life sciences/healthcare experience OR Bachelor’s degree and 7 years of life sciences/healthcare experience
- 3 years of pharmaceutical clinical drug development experience
- 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
- Vast opportunities to learn, develop, and move up and across our global organization.
- Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
- Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
- Flexible work arrangements.
Job title
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