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Clinical Scientist Associate Director, Cardiovascular
AmgenClinical Scientist Associate Director at Amgen overseeing global cardiovascular clinical trials and ensuring high-quality data for regulatory submissions. Collaborating cross-functionally for successful delivery of projects.
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical developmentclinical trial process improvementscardiovascular medicinedata cleaningdatabase lockdata extractionendpoint validationregulatory submission documentsclinical data reviewsignal detection
Soft Skills
communication skillspresentation skillscollaborationrisk identificationmitigation strategies
Certifications
Good Clinical Practice (GCP)