Amgen Global Early Clinical Development Manager - Early Development in Thousand Oaks, California
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 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
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
Master's Degree and 3 years of Clinical experience
Bachelor's Degree and 5 years of Clinical experience
Associate's degree and 10 years of Clinical experience
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)
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen focuses on areas of high unmet medical need and uses 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.
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.