Global Study Management Director - Biosimilars
The Global Study Management Director will be a single point of accountability for operational strategy, planning, risk assessment/mitigation, and overall execution of support of the Amgen clinical trial programs managed from within the Biosimilars department. The Director will ensure excellence/consistency in clinical trial execution within Amgen clinical trial programs managed from within the Biosimilars department and is accountable for delivery of clinical programs on-time, with high quality, and within budget. Additional responsibilities will include initiation of continuous improvement initiatives in Amgen clinical trial programs managed from within the Biosimilars department, line management and resource planning of Biosimilars Senior Clinical Research Study Manager (Biosimilars Sr. CRSM) and Biosimilars Clinical Research Study Manager (Biosimilars CRSM), if applicable.
- 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
- 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
- Bachelor's degree & 5 years of directly related experience
Master's degree & 3 years of directly related experience
Doctorate degree & 2 years of directly related experience
- Experience with oversight of clinical research organizations (CROs)
- Experience in leading cross-functional teams
- 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
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.