Clinical Scientist Director – Cardiovascular Trials
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Job Description
Clinical Scientist Director managing cardiovascular trials for Amgen. Supporting execution and quality delivery of global late-stage clinical studies in cardiovascular research.
Responsibilities:
- Support the execution of cardiovascular trials by translating scientific and clinical strategy into high-quality study delivery across global, complex, late-stage clinical trials.
- Provide hands-on oversight of protocol execution, medical data review, endpoint quality, and cross-functional issue resolution to enable timely, decision-ready data.
- Serve as a clinical and scientific subject-matter expert for cardiovascular trials, with deep understanding of cardiovascular disease, endpoint strategy, protocol execution, and data integrity.
- Contribute to medical monitoring activities and support ongoing review of subject-level and aggregate clinical data to identify safety signals, endpoint trends, protocol deviations, and emerging operational or scientific risks.
- Present information internally and externally, anticipating and actively managing issues across a broad spectrum of cross-functional stakeholders, governance bodies, and external partners.
- Provide guidance and oversight in the identification and management of collaborators, consultants, adjudication vendors, and/or Clinical Research Organizations (CROs) to support successful trial delivery.
- Work cross-functionally to translate clinical strategy into study concept documents, protocols, endpoint definitions, charters, data review plans, and other key trial documents required for CV trial execution.
- Ensure the scientific and operational integrity of protocols and clinical plans, including delivery of final protocol content 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 of results.
- Review and analyze clinical trial data to ensure accuracy, completeness, consistency, and adherence to protocol, endpoint definitions, and regulatory requirements, with strong focus on MACE and other cardiovascular outcome measures where applicable.
- Lead thorough data quality assessments in the context of a data monitoring and review plan to maintain high standards of endpoint reliability, safety oversight, and inspection readiness throughout the trial lifecycle.
Requirements:
- Doctorate degree and 4 years of life sciences/healthcare experience OR Master’s degree and 7 years of life sciences/healthcare experience OR Bachelor’s degree and 9 years of life sciences/healthcare experience
- 5+ years of pharmaceutical clinical drug development experience, including meaningful experience supporting late-stage, global clinical trials.
- Strong preference for individuals with a proven track record of clinical trial execution, inspection readiness, and process improvement in complex development programs.
- Industry or academic experience in cardiovascular medicine and/or cardiovascular outcomes trials; experience in large event-driven studies strongly preferred.
- Experience designing, monitoring, and implementing global clinical trials, including interpretation of test results and subject-level data in compliance with Good Clinical Practice standards and regulatory requirements.
- Understanding 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 submissions and health authority responses, including preparation of high-level clinical content and issue-resolution materials.
- Experience contributing to scientific publications, congress abstracts, and data presentations at scientific conferences.
- Experience in clinical data review and analysis tools such as Spotfire, listings review platforms, or other data visualization and analysis tools.
Benefits:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- 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 plans
- Flexible work models where possible.
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