Clinical Scientist Director – Early Development, Oncology

• 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
• Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
• Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
• Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
• Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
• Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
• Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results
• Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements
• 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

• Doctorate degree and 4 years of life sciences/healthcare experience
• Master’s degree and 7 years of life sciences/healthcare experience
• Bachelor’s degree and 9 years of life sciences/healthcare experience
• 5 years of pharmaceutical clinical drug development experience
• Industry or academic experience in early-phase drug development within Oncology
• Strong communication & presentation skills in English
• Experience with designing, monitoring, and implementing clinical trials for Oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
• Understanding of conducting study data readout activities, including data cleaning, database 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

Strong preference for individuals with proven track record of clinical trial process improvement

• 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