Global Early Clinical Development Manager - Early Development
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.Global Early Clinical Development Manager - Early DevelopmentLive
What you will do
Lets do this. Lets change the world. In this vital role you will a part of our Global Development Operations. You will be accountable for the execution, management and reporting of early development clinical trials (phase 0 - 1b) and 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. You will collaborate amongst peers and cross functionally with your clinical study team and evidence generating team.
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 the 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 escalated 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)
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 an ambitious leader with these qualifications.Basic Qualifications:
- 4+years 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 programs
- Bachelors Degree or equivalent required (scientific or healthcare discipline preferred).
- 6+ years of experience of clinical and drug development
- Advanced degree in the scientific or healthcare discipline preferred
- Previous experience in managing a platform/indication
- Candidates with comparable depth and breadth of training and experience are eligible for consideration
- Experience with both conventional and innovative trial designs in different phases of drug development
Some of the vast rewards of working here
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.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.
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.