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In this vital role, the Clinical Scientist Director will support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials. The Clinical Scientist serves as a key clinical development team member, providing hands-on oversight of protocol execution, medical data review, and clinical data quality to enable high-quality, decision-ready data. The Clinical Scientist works collaboratively within cross-functional teams to ensure clinical trials are executed in alignment with protocol intent, regulatory expectations, and Amgen quality standards.
Job Responsibility
Support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials
Serve as a key clinical development team member
Provide hands-on oversight of protocol execution, medical data review, and clinical data quality
Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data
Present information internally and externally
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs)
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), 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
Conduct thorough data quality assessments in the context of a data monitoring plan
Requirements
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 experience in late-phase drug development for oncology (prostate-specific experience is a plus)
Strong communication & presentation skills
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
Experience drafting high level submission documents for regulatory submissions
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
Nice to have
Proven track record of clinical trial process improvement
Prostate-specific experience
What we offer
Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits