Clinical Scientist Associate Director – Cardiovascular Trials

Clinical Scientist Associate Director, Cardiovascular

Responsibilities:
- Serve as a clinical and scientific subject-matter expert for cardiovascular trials, including cardiovascular disease, endpoint strategy, protocol execution, and data integrity.
- Support medical monitoring by reviewing subject-level and aggregate clinical data to identify safety signals, endpoint trends, protocol deviations, and emerging operational/scientific risks.
- Present information internally and externally and actively manage issues across cross-functional stakeholders, governance bodies, and external partners.
- Provide guidance/oversight for collaborators, consultants, adjudication vendors, and/or CROs to support trial delivery.
- Translate clinical strategy into study concept documents, protocols, endpoint definitions, charters, data review plans, and other CV trial documents.
- Ensure scientific and operational integrity of protocols and clinical plans, including final protocol content delivery and governance approvals for large global event-driven studies.
- Provide clinical input into study startup, trial conduct, enrollment oversight, endpoint ascertainment, adjudication readiness, data review, and interpretation.
- Review/analyze clinical trial data for accuracy, completeness, consistency, and adherence to protocol, endpoint definitions, and regulatory requirements (focus on MACE and other cardiovascular outcome measures where applicable).
- Lead data quality assessments aligned to a data monitoring and review plan to maintain endpoint reliability, safety oversight, and inspection readiness.

Basic Qualifications:
- Doctorate + 3 years clinical science experience
OR Master’s + 5 years
OR Bachelor’s + 7 years
OR Associate’s + 12 years
OR High school diploma/GED + 14 years

Preferred Qualifications / Skills:
- 3+ years pharmaceutical clinical drug development experience supporting late-stage, global clinical trials.
- Proven track record of clinical trial execution, inspection readiness, and process improvement in complex programs.
- Industry/academic cardiovascular medicine and/or cardiovascular outcomes trial experience; event-driven studies strongly preferred.
- Strong written/oral communication and presentation skills for leadership and external stakeholders.
- Experience designing, monitoring, and implementing global clinical trials; subject-level interpretation in compliance with GCP and regulatory requirements.
- Understanding of study data readout activities (data cleaning, database lock, data extraction, endpoint validation, analysis outputs for topline/final results).
- Experience with regulatory submissions and health authority responses (high-level clinical content and issue-resolution materials).
- Experience with scientific publications, congress abstracts, and conference presentations.
- Experience with clinical data review/analysis tools (e.g., Spotfire, listings review platforms, other visualization/analysis tools).

Application Instructions:
- Apply now (no application deadline; applications accepted until sufficient candidates or selection).