Clinical Scientist Associate Director
Amgen · PT
Career Category Clinical Job Description What you will do In this role, the Clinical Scientist Associate Director supports the design, execution, and oversig...
Job description
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,...