Global Study Management Director - Biosimilars
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Apr 4, 2021
View more
- Discipline
- Clinical, Clinical Research, Clinical Trials, Science/R&D, Biotechnology, Pharmacology
- Required Education
- Other
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
Responsible for:
- Accountable for global biosimilar development operational strategy, planning, and execution through oversight of cross functional study activities in partnership with Contract Research Organization (CRO)
- Accountable for execution of clinical study(ies) in partnership with CRO in accordance with applicable SOPs and ICH/GCP guidelines
- Oversight of clinical studies to ensure execution with high-quality, on-time, and within budget
- Managing program-level operational issues and oversight of study team issue escalation
- Maintaining global business relationships cross functionally, and communicating global status of clinical study programs to senior management
- Maintaining and improving global collaboration within Amgen and with CRO
- Leading initiatives and process improvement work streams including vendor selection and process mapping of CROs
- Lead or co-lead CRO Operational Management Teams (OMTs) and vendor management
- Line management and mentoring of Biosimilars - Senior Global Study Manager (Biosimilars - Sr. GSM) and Biosimilars - Global Study Manager (Biosimilars - GSM), it applicable.
Decision Making Authority
- Global study operational decisions
- Financial approval consistent with grade
- Clinical study budgets and timelines, as appropriate
- Vendor scopes of work and budgets
- In partnership with the CRO:
- Operational and timeline decisions
- Protocol implementation decisions
- Study feasibility contents
- Content of study-specific documents
- Final country and site lists
- Recruitment targets
Outputs
- Oversight of study start-up/execution/close out activities in partnership with CRO and third-party suppliers
- Along with the CRO, study-related documents, plans, site lists and timelines
- Presentations to management and external audiences (when appropriate)
- Amgen/CRO Process mapping documents
- Recommendations for process improvement initiatives
Role Qualifications, Experience, Knowledge & Competencies
Basic Qualifications
- Bachelor's degree & 5 years of directly related experience
OR
Master's degree & 3 years of directly related experience
OR
Doctorate degree & 2 years of directly related experience - Experience with oversight of clinical research organizations (CROs)
- Experience in leading cross-functional teams
Preferred Qualifications
- Master's degree in sciences
- 7-9 years work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical studies at a biotech, pharmaceutical or CRO company)
- Experience in oversight of outside vendors (CROs, central labs, etc
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, 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.
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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