Experteer Overview As a Clinical Scientist Associate Director, you lead design, execution, and oversight of late-phase global trials to yield decision-ready data for regulatory submissions and scientific dissemination. You partner with cross-functional teams to shape endpoint strategy, safety monitoring, and data interpretation, ensuring high-quality outcomes. You influence protocol development, monitoring plans, and DMC interactions, driving timely insights across indications. This role offers impact through shaping clinical strategies, data integrity, and general trial delivery.Compensaciones / Beneficios
- Design, start-up and oversee global clinical trials ensuring protocol compliance and data integrity
- Contribute to development of clinical documents (protocols, SAPs, investigator brochures, regulatory submissions) with focus on endpoints and safety
- Collaborate with cross-functional teams for endpoint strategy, event adjudication, and safety monitoring
- Develop and oversee endpoint adjudication charters, safety monitoring plans, and DMC interactions
- Provide clinical input into data management plans, CRF design, and data review emphasizing key endpoints and safety
- Conduct ongoing clinical data review and signal detection to resolve safety and data quality issues across sites
- Support interim analyses, database lock activities, and top-line data readouts




- Assist Development Lead and Clinical Scientist Director with medical monitoring and CRO/vendor oversight
- Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs to ensure successful study delivery
- Contribute to study reports, regulatory submissions, scientific publications, and stakeholder presentations
- Identify operational or scientific risks and implement mitigation strategies across teamsResponsabilidades
- Doctorate in life sciences with 3+ years of healthcare experience OR Master’s with 5+ years OR Bachelor’s with 7+ years
- 3 years of pharmaceutical clinical drug development experience, including late-stage global trials
- Experience contributing to clinical trial process improvements in a therapeutic area or study team
- Experience in large global studies is preferred
- Strong communication and presentation skills for cross-functional and leadership audiences
- Experience with GCP and applicable regulatory requirements
- Knowledge of data readout activities including data cleaning, database lock, data extraction, endpoint validation, and generation of analysis outputs
- Experience supporting regulatory submissions and responses
- Experience as a contributing author on publications or data presentations
- Experience with clinical data review and analysis tools (e.G., Spotfire)Requisitos principales
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📌 Clinical Scientist Associate Director (España)
🏢 Amgen
📍 España