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.

BASIC QUALIFICATIONS:

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

PREFERRED QUALIFICATIONS:

• 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 both internally or externally (both written and oral)
• Experience with designing, monitoring, and implementing oncology clinical trials 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

Let’s do this. Let’s change the world. In this vital role you will contribute to late phase clinical development of oncology. They will collaborate on teams to define, design, and deliver late phase clinical results, supplemented by translational projects in the ongoing strategy for drug development. Through their role, the Medical Director provides subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer. They will 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) 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), 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 to maintain high standards of data accuracy and integrity throughout the trial lifecycle