Senior Manager Global Observational Program Management
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.Senior Manager Global Observational Program ManagementLive
What you will do
Lets do this. Lets change the world. In this vital role you will work in CfOR Operations and lead the study management and procedures within CfOR. Recognized as a scientific contributor and an owner or contributor for SOPs governing observational research. Reporting to the Director of Development Operations, you will be responsible for resource and portfolio assessment, and conducting advance planning and anticipating future resource, funding and decision making
Supports the management of research strategy within the product team and observational research TA specifically by facilitating the conduct of ancillary/secondary studies with external organizations (GCPM-OR, Medical, GCPM-TA); this may include protocol development, oversight of Statistical Analysis Plan, and management of regulatory requirements for these studies
Responsible for oversight of high-quality observational research to support product strategy within TA.
Supports relationships with key leaders including Observational Research Review Group (ORRG); ensures that operating procedures for ORRG align with observational study mission.
Develop processes including innovative ways to improve efficiencies; works with the Product Teams within CfOR to ensure that SOPs align with best practices.
Provides input into observational research department meetings
Stays abreast of the latest developments in the field and drug development and supplies to the field including regulatory requirements globally.
Supervise the quality and scientific integrity of observational clinical operations at a global level
Collaborate with cross functional partners to ensure timely and on budget execution of study results and leads the Operations Team to drive effective decision making
Plan and lead the reporting of selected clinical studies conducted by Center for Observational Research through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/results.
Ensure implementation and conduct of studies in accordance with SOPs and ICH-GCP guidelines
Owner of the Observational Research Standard Operational Procedures
Support the development and delivery of key components of the Evidence Generation Plan
Support complex development decision making throughout product development cycle. The Sr. Manager leads teams through a qualitative approach to build strategic development options through framing, issue raising and classification, decision hierarchy, and strategy table generation
Identify value measures, trade-offs, risks, and gaps in development strategy
Bring the right functions together at the right time and integrate cross-functional input to facilitate endto-end observational research development.
Objective leader that influences the adoption of novel or innovative ways and provides strategic leadership required to drive year over year efficiency through yield and capacity projects on site.
Building and maintain positive collaborations; communicating, seeking advice, and facilitating critical business decisions.
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is a program leader with these qualifications.
Doctorate degree and 2 years of research and program management experience Or
Masters degree and 6 years of research and program management experience Or
Bachelors degree and 8 years of relative experience Or
Associates degree and 10 years of relative experience Or
High school diploma / GED and 12 years of relative experience
Masters or Doctorate level degree in observational research operations and 5 years of research and program management experience.
Experience in the strategic planning, operations, and budgeting of observational research studies within Pharmaceutical or Public Health settings.
Clinical Study Management experience.
Experience in project planning, management and observational research to support drug development
Knowledge of regulations globally.
High proficiency with Microsoft Office and SharePoint, Tableau or other data visualization tools and Observational research databases.
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.