Clinical Scientist Associate Director

Job Summary

Amgen Clinical Scientist Associate Director remote type Flex Commuter / Hybrid Career Category Clinical Job Description What you will do In this role, the Clinical Scientist Associate Director supports the design, execution, and oversight of clinical trials and other late-phase global clinical studies. The role contributes to protocol development, study execution, medical monitoring support, and clinical data review, ensuring delivery of high-quality, decision-ready clinical data for regulatory submissions and scientific dissemination. Support the design, start-up, and execution of global clinical trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards. Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with focus on study endpoints, key efficacy outcomes, and safety assessments. Collaborate with cross-functional teams to support endpoint strategy, event adjudication processes, and safety monitoring. Participate in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions. Provide clinical input into data management plans, CRF design, and clinical data review, with focus on key study endpoints, efficacy and safety outcomes, and/or imaging or biomarker endpoints, as applicable. Conduct ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites....