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 be accountable for the execution, management and reporting of early development clinical trials. The GECDM is a member of one or more cross-functional clinical study teams and a core member of the Evidence Generating Team. These complex programs focus on the rapid development of emerging New Molecular Entities (NMEs) with limited clinical data, and as such, require implementation of novel and highly flexible global operational strategies to support exploratory hypotheses, patient populations including biomarkers and diagnostics. A GECDM collaborates amongst peers and Evidence Generating Team members.
- Leads the Program level planning of the overall operational deliverables at the Evidence Generation Team meetings
- Develop the strategic scenarios on the designs of the clinical development plan as part of the EGP development
- Drives the Operational Strategy of the Molecule
- Gives to the development of the clinical protocol and are the authors of the protocol
- Supply to the writing and review of study related documentation, including safety and regulatory documents, Clinical Study Report and publications
- Responsible for generating and supervising the study budgets and timelines and updating systems to changes of the assumptions
- Responsible for the ongoing evaluation of the feasibility of the program strategy and amending study timelines, as appropriate.
- Identify, and perform feasibility for the selection of early phase clinical investigators
- Help organize and assist in investigator and site meetings, initiating early engagement with key thought leaders
- Responsible for ensuring all site and study team members receive adequate training to conduct early development studies
- Drives the oversight of the preparation of site initiation regulatory documents, approve site visit report and provide overall management of study related activities
- Owns the coordination of the Dose Level Review meetings, communicates
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
- Doctorate Degree OR
- Master's Degree and 3 years of Clinical experience OR
- Bachelor's Degree and 5 years of Clinical experience OR
- Associate's degree and 10 years of Clinical experience OR
- High school diploma/GED and 12 years of Clinical experience
- MS, RN, or PharmD Degree
- More than 7 years of experience in life sciences or medically related field
- 4+ years of bio-pharmaceutical clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials at academic institutions or working on clinical trials in a biotech, pharmaceutical or CRO company
- Management experience of direct reports
- Experience in oversight of Functional Service Providers, outside vendors (CROs, central labs, imaging vendors, etc)
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.