This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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
Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results
Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements
Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle
Requirements
Doctorate degree and 4 years of life sciences/healthcare experience
Master’s degree and 7 years of life sciences/healthcare experience
Bachelor’s degree and 9 years of life sciences/healthcare experience
Nice to have
5 years of pharmaceutical clinical drug development experience
Strong preference for individuals with proven track record of clinical trial process improvement
Industry or academic experience in late-phase drug development for Oncology
Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral)
Experience with designing, monitoring, and implementing clinical trials for Oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data
Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
Serving as a contributing author to scientific publications and data presentations at scientific conferences
Experience in clinical data analysis such as Spotfire or other data analysis tools
What we offer
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, and 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, including remote and hybrid work arrangements, where possible