Global Early Clinical Development Manager - Early Development
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Apr 24, 2019
View more
- Discipline
- Clinical, Clinical Development
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
Amgen Early Clinical Development 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.
Responsibilities:
- Lead 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
- Drive the Operational Strategy of the Molecule
- Contribute 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 overseeing 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
- Drive the oversight of the preparation of site initiation regulatory documents, approve site visit report and provide overall management of study related activities
- Lead the coordination of the Dose Level Review meetings, communicates
Basic 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
Preferred Qualifications:
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)
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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