What You Will Do
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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.
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- 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 DMC interactions.
- Provide clinical input into data management plans, CRF design, and clinical data review, focusing 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 integral trial sites.
- Support preparation and interpretation of interim analyses, database lock activities, and top‑line data readouts.
- Assist Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees.
- Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of clinical studies across relevant indica
📌 Clinical Scientist Associate Director (Madrid)
🏢 Amgen
📍 Madrid