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. 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.
Responsibilities
- Contribute to late phase clinical development of oncology.
- Collaborate on teams to define, design, and deliver late phase clinical results.
- Provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer.
- Contribute intellectual insight into experimental design and data analysis.
- Serve as an internal clinical expert in translational and clinical oncology.
- Support medical monitor in clinical trials and assist in resolving issues that may arise.
- 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 oncology collaborators, consultants, and/or Clinical Research Organizations (CROs).
- 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), their delivery, clinical data review, 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.
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.
- Strong preference for individuals with proven track record of oncology clinical trial process improvement.
- Industry or academic experience in late-phase oncology drug development.
- Strong communication & presentation skills to clearly communicate scientific concepts/data to leadership committees.
- Experience with designing, monitoring, and implementing oncology clinical trials and interpreting test results in compliance with Good Clinical Practice standards.
- Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract.
- Experience drafting high level submission documents for regulatory submissions.
- 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.
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.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models, including remote and hybrid work arrangements.
