Amgen logo
Amgen

Founded in 1980, Amgen (short for Applied Molecular Genetics) is a biotechnology firm focused on developing human therapeutics. As an employer, Amgen has been d

Clinical Scientist Associate Director, Cardiovascular

Location

United States

Posted

2 days ago

Salary

$169.8K - $229.7K / year

Seniority

Senior

Postgraduate Degree3 yrs expExperience acceptedEnglish

Job Description

Clinical Scientist Associate Director, Cardiovascular

Amgen

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

Job 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 clearly 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.

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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