Clinical Scientist Associate Director

This is a fully remote position, open to applicants in Spain.

📋 Description

• Assist in the design, initiation, and execution of worldwide clinical trials, ensuring compliance with protocols, regulatory standards, and data integrity requirements.

• Aid in the creation of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, emphasizing study endpoints, key efficacy outcomes, and safety evaluations.

• Work collaboratively with cross-functional teams to enhance endpoint strategy, event adjudication processes, and safety monitoring efforts.

• Engage in the development and supervision of endpoint adjudication charters, safety monitoring plans, and interactions with the Data Monitoring Committee (DMC).

• Offer clinical insights into data management plans, CRF design, and clinical data review, focusing on critical study endpoints, efficacy and safety outcomes, and/or imaging or biomarker endpoints, as applicable.

• Perform continuous clinical data reviews and signal detection, aiding in the identification and resolution of safety and data quality issues across global trial sites.

• Assist in the preparation and interpretation of interim analyses, database lock activities, and top-line data readouts.

• Support the Development Lead and Clinical Scientist Director with medical monitoring tasks and management of CROs, vendors, and adjudication committees.

• Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure the successful execution of clinical studies across relevant indications and endpoint strategies.

• Assist in the creation of clinical study reports, regulatory submissions, scientific publications, and presentations for both internal and external stakeholders.

• Recognize operational or scientific risks and proactively implement mitigation strategies across cross-functional teams.

⛳️ Requirements

• Doctorate degree with 3 years of experience in life sciences/healthcare, OR a Master’s degree with 5 years of experience, OR a Bachelor’s degree with 7 years of experience in life sciences/healthcare.

• At least 3 years of experience in pharmaceutical clinical drug development, including support for late-stage, global clinical trials.

• Proven track record of contributing to enhancements in the clinical trial process within a therapeutic area or study team context.

• Relevant industry or academic experience in a therapeutic area and/or clinical trials; experience in large global studies is preferred.

• Excellent communication and presentation skills, with the ability to effectively articulate scientific concepts and clinical data to cross-functional teams and leadership audiences, both in writing and orally.

• Experience in supporting the design, monitoring, and execution of clinical trials in accordance with Good Clinical Practice standards and applicable regulatory requirements.

• Familiarity with study data readout activities, including data cleaning, database lock, data extraction, endpoint validation, and the production of analysis outputs to support topline and final results.

• Background in contributing to regulatory submission documents and assisting with clinical regulatory responses for health authority interactions under supervision.

• Experience as a contributing author on scientific publications or data presentations for internal forums or scientific conferences.

• Proficiency in clinical data review and analysis tools such as Spotfire, listings review platforms, or other data visualization and analysis tools.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health benefits including medical, dental, and vision coverage.

• Opportunities for professional development and continued education.

• Flexible working hours and remote work options.

• Collaborative and inclusive company culture.