Descripción de la oferta
## Clinical Scientist Associate DirectorApplyremote type: Flex Commuter / Hybridlocations: Spain - Remotetime type: Full timeposted on: Posted Todayjob requisition id: R-246860## **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.* 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 indications and endpoint strategies.* Contribute to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders.* Identify operational or scientific risks and proactively implement mitigation strategies across cross-functional teams.**What we expect of you**We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.**Basic Qualifications:**Doctorate degree and 3 years of life sciences/healthcare experienceORMaster’s degree and 5 years of life sciences/healthcare experienceORBachelor’s degree and 7 years of life sciences/healthcare experience**Preferred Qualifications:*** 3 years of pharmaceutical clinical drug development experience, including experience supporting late-stage, global clinical trials.* Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment* Industry or academic experience in a relevant therapeutic area and/or clinical trials; experience in large global studies preferred.* Strong communication and presentation skills, with the ability to clearly convey scientific concepts and clinical data to cross-functional teams and leadership audiences, both written and oral* Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements* Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, endpoint validation, and generation of analysis outputs to support topline and final results.* Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance* Experience serving as a contributing author on scientific publications or data presentations for internal forums or scientific conferences* Experience in clinical data review and analysis tools such as Spotfire, listings review platforms, or other data visualization and analysis tools..**Salary Range**90 787,65 EUR - 122 830,35 EUR
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