Few careers offer the chance to make a difference in people's lives. Take advantage of the opportunity at Amgen, the world's largest biotechnology company. With global manufacturing operations and clinical development sites on three continents, Amgen is focused and committed to making our products available to improve patients' lives through innovative science.
Early Development Clinical Operations is looking for a Global Early Clinical Development Manager (GECDM) to 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.
- The Global Early Clinical Development Manager will work in varying therapeutic areas including oncology, cardiovascular, inflammation, neuroscience and healthy volunteer.
- Leads the Program level planning of the overall operational deliverables at the Evidence Generating Team meetings
- Develop the strategic scenarios on the designs of the clinical development plan as part of the EGP generation
- Drives the Operational Strategy of the Molecule
- Contributes to the development of the clinical protocol and are the authors of the protocol
- Contribute to the writing and review of study related documentation, including safety and regulatory documents, Clinical Study Report and publications
- Responsible for generating and leading all aspects of 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 prioritize 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
- Leads the coordination of the Dose Level Review meetings, communicates decisions of the meetings, and operationalizes Dose Level Review meeting outcomes
- 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
- 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 (CRO's, central labs, imaging vendors, etc)
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.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 provides a comprehensive Total Rewards Program designed to enhance the long term financial, physical, and overall well-being of our staff and their families. We offer competitive compensation, long term incentive opportunities, generous paid time off, 401k, medical, dental and vision just to name a few.
As an organization dedicated to improving the quality of life for people around the world, Amgen champions 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.
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 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.?