Clinical Scientist Associate Director, Cardiovascular

Overview

Supports the design, execution, and oversight of cardiovascular trials and other late-phase global clinical studies.

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.

Supports the design, start-up, and execution of global cardiovascular trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards.

Contributes to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with particular focus on cardiovascular endpoints and safety outcomes.

Collaborates with cross-functional teams to support endpoint strategy, event adjudication processes, and cardiovascular safety monitoring.

Participates in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions.

Provides clinical input into data management plans, CRF design, and clinical data review, with focus on cardiovascular outcomes endpoints (e. g.

MACE, hospitalization events, mortality) and/or cardiac imaging endpoints.

Conducts ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites.

Supports preparation and interpretation of interim analyses, database lock activities, and top-line data readouts.

Assists Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees.

Collaborates with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of cardiovascular outcomes and/or cardiac imaging studies.

Contributes to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders.

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

Responsibilities

• Contributes to protocol development, study execution, medical monitoring support, and clinical data review to deliver high-quality, decision-ready data for regulatory submissions and dissemination.
• Supports design, start-up, and execution of global cardiovascular trials with adherence to protocol, regulatory requirements, and data integrity standards.
• Contributes to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents with focus on cardiovascular endpoints and safety outcomes.
• Collaborates with cross-functional teams to support endpoint strategy, event adjudication processes, and cardiovascular safety monitoring.
• Participates in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions.
• Provides clinical input into data management plans, CRF design, and clinical data review focusing on cardiovascular outcomes endpoints and/or cardiac imaging endpoints.
• Conducts ongoing clinical data review and signal detection to identify and resolve safety and data quality issues across global trial sites.
• Supports preparation and interpretation of interim analyses, database lock activities, and top-line data readouts.
• Assists Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees.
• Collaborates with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to deliver cardiovascular outcomes and/or cardiac imaging studies.
• Contributes to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders.
• Identifies operational or scientific risks and proactively implements mitigation strategies across cross-functional teams.

Requirements

• Doctorate degree and 3 years of clinical development experience OR Master’s degree and 5 years of clinical development experience OR Bachelor’s degree and 7 years of clinical development experience OR Associate’s degree and 12 years of clinical development experience OR High school diploma / GED and 14 years of clinical development experience
• 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 cardiovascular medicine and/or cardiovascular outcomes trials; experience in large event-driven studies preferred
• Strong communication and presentation skills, with the ability to 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
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