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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. 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.
Job Responsibility
Support set up and execution of late phase clinical trials with a focus on data quality
Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
Provide input into and implementation of data management plan, CRF design, and data review oversight
Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
Assists the management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
Anticipate and actively manage problems across a broad spectrum of cross-functional teams
Work cross-functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Support appropriate training, recruitment, and development requirements for matrix team resources
Requirements
Doctorate degree and 3 years of life sciences/healthcare experience
Master's degree and 5 years of life sciences/healthcare experience
Bachelor's degree and 7 years of life sciences/healthcare experience
Nice to have
3 years of experience in a pharmaceutical industry setting with at least 1 year supporting early or late-phase clinical development within a relevant therapeutic area or disease indication (oncology preferred)
Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
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, and generation of clinical data outputs
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 analysis such as Spotfire or other data analysis tools
What we offer
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
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, including remote and hybrid work arrangements, where possible