Clinical Sciences Director – Early Development, Oncology

Responsibilities • support early-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials • Provide hands-on oversight of protocol execution, medical data review, and clinical data quality to enable high-quality, decision-ready data • work collaboratively within cross-functional teams to ensure clinical trials are executed in alignment with protocol intent, regulatory expectations, and Amgen quality standards • 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), 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 • 5 years of pharmaceutical clinical drug development experience • Strong preference for individuals with proven track record of clinical trial process improvement • Industry or academic experience in early-phase drug development within 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 within 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