Clinical Scientist Associate Director, Cardiovascular

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

📋 Description

• Aids in the design, implementation, and management of cardiovascular trials and other late-phase global clinical studies.

• Plays a role in protocol formulation, study execution, medical monitoring assistance, and clinical data analysis, ensuring the provision of high-quality, decision-ready clinical data for regulatory submissions and scientific communication.

• Assists in the design, initiation, and implementation of global cardiovascular trials, ensuring compliance with protocols, regulatory standards, and data integrity benchmarks.

• Contributes to the creation of clinical protocols, statistical analysis frameworks, investigator brochures, and regulatory documents, with a specific emphasis on cardiovascular endpoints and safety outcomes.

• Works collaboratively with cross-functional teams to bolster endpoint strategies, event adjudication procedures, and cardiovascular safety monitoring efforts.

• Engages in the development and management of endpoint adjudication charters, safety monitoring plans, and interactions with Data Monitoring Committees (DMC).

• Provides clinical insights for data management plans, CRF design, and clinical data assessments, focusing on cardiovascular outcome endpoints (e.g., MACE, hospitalization events, mortality) and/or cardiac imaging endpoints.

• Performs continuous clinical data examinations and signal detection, aiding in the identification and resolution of safety and data quality challenges across global trial locations.

• Assists in the preparation and interpretation of interim analyses, database lock processes, and preliminary data reports.

• Supports the Development Lead and Clinical Scientist Director in medical monitoring tasks and oversight of CROs, vendors, and adjudication committees.

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

• Contributes to clinical study reports, regulatory documentation, scientific publications, and presentations aimed at both 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.

• Minimum of 3 years of experience in pharmaceutical clinical drug development, particularly in late-stage, global clinical trials.

• Proven experience in enhancing clinical trial processes within a therapeutic area or study team setting.

• Background in industry or academia related to cardiovascular medicine and/or cardiovascular outcomes trials; experience in large event-driven studies is preferred.

• Excellent communication and presentation skills, capable of effectively conveying scientific concepts and clinical data to cross-functional teams and leadership audiences, both in writing and verbally.

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

• Familiarity with study data readout activities, including data cleaning, database locking, data extraction, endpoint validation, and generating analysis outputs to support topline and final results.

• Experience in contributing to regulatory submission documentation and assisting with clinical regulatory responses for health authority engagements under supervision.

• Experience as a contributing author for scientific publications or data presentations intended for internal discussions or scientific conferences.

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

🏝️ Benefits

• A comprehensive employee benefits package, featuring a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision insurance.

• Life and disability coverage.

• Flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off policies.

• Flexible work arrangements where feasible.