HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career.
How will you put your skills, experience and passion to work toward your goals?
At Amgen, our shared missionto serve patientsdrives all that we do.
It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide.
Come do your best work alongside other innovative, driven professionals in this meaningful role.
Global Early Clinical Development Manager (GECDM) Live What you will do Lets do this.
Lets change the world.
In this vital role you will be a part of our Global Development Operations and be accountable for the implementation, management and reporting of early development clinical trials (phase 0
– 1b).
You will also be a member of one or more cross-functional clinical study teams and a core member of the evidence generating team.
These programs focus on the rapid development of emerging New Molecular Entities (NMEs) and require implementation of novel and highly flexible global operational strategies.
Global Early Clinical Development Managers will work in varying therapeutic areas including hematology/oncology, cardiometabolic, inflammation and healthy volunteer.
Responsibilities: Leads study level planning of the overall clinical operation results Develops early phase clinical operation strategy and contributes to strategic scenario planning in clinical development plan Develops and maintains study timeline and development of clinical protocol and informed consent Contributes to the development and/or review of study-related documentation, including but not limited to monitoring plan, risk management tool, eCRF, manuals, training materials, safety and regulatory documents, and clinical study report, etc.
Leads clinical study team to identify, evaluate and select clinical sites Handles the day-to-day operations of clinical trial at a global level and resolves issues called out by the local study team Maintains close collaboration with site investigators through regular and ad hoc investigator and site meetings, keeping investigators, often including key thought leaders, engaged to the study Trains study team members and/or sites to conduct the study Leads and coordinates Dose Level Review meetings, communicates decisions of the meetings, and operationalize Dose Level Review meeting outcomes Manages vendors and functional service providers (FSP) Win What we expect of you We are all different, yet we all use our unique contributions to serve patients.
The Clinical professional we seek is a study manger with these qualifications.
Basic Qualifications: Masters degree and 3 years of clinical experience OR Bachelors degree and 5 years of clinical experience Preferred Qualifications: Bachelors Degree or equivalent required (scientific or healthcare field preferred).
4years of experience of clinical research and study management Experience in clinical program management Substantial experience in biotechnology and/or pharmaceutical clinical research with responsibilities for major aspects of strategic planning, organization, implementation, and delivery of clinical program Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
The annual salary range for this opportunity in the U.S.
is $117,785
– $136,224.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: 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 and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear.
Join us.
careers.amgen.com Join Us If 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 cancers, 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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.