Clinical Scientist Director - Cardiovascular Trials

Amgen•Thousand Oaks, CA

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Clinical Scientist Director, Cardiovascular What you will do Let’s do this. Let’s change the world. In this vital role, the Clinical Scientist Director will support the execution of cardiovascular trials by translating scientific and clinical strategy into high-quality study delivery across global, complex, late-stage clinical trials. The Clinical Scientist serves as a key clinical development team member, providing hands-on oversight of protocol execution, medical data review, endpoint quality, and cross-functional issue resolution to enable timely, decision-ready data. This role works collaboratively across clinical, medical, operational, data management, safety, and regulatory teams to ensure studies are conducted in alignment with protocol intent, study timelines, regulatory expectations, and Amgen quality standards. 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

Nice To Haves

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.
Strong communication and presentation skills to clearly communicate scientific concepts, risk assessments, and clinical data to leadership committees and external stakeholders in both written and oral formats.
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.

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.

Benefits

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
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