Clinical Scientist Director, Late Development Oncology- Thoracic/GI

About the role

Join Amgen’s mission of serving patients. This role supports late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials.

Responsibilities

• Translate scientific and clinical strategy into actionable execution across clinical trials
• Provide hands-on oversight of protocol execution, medical data review, and clinical data quality
• Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data
• Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
• 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 to maintain high standards of data accuracy and integrity throughout the trial lifecycle

Requirements

• Doctorate degree and 4 years of clinical development experience OR Master’s degree and 7 years of clinical development experience OR Bachelor’s degree and 9 years of clinical development experience
• Strong preference for individuals with proven track record of clinical trial process improvement
• Industry or academic experience in late-phase drug development for Oncology
• Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral)
• Experience with designing, monitoring, and implementing clinical trials for Oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
• Experience conducting study data readout activities, including data cleaning, data base 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

Qualifications

• Doctorate degree and 4 years of clinical development experience
• Master’s degree and 7 years of clinical development experience
• Bachelor’s degree and 9 years of clinical development experience