Role OverviewJoin Amgen's mission of serving patients. The Director, Local Study Operations Manager provides strategic and operational leadership for the country LSOM organization, accountable for the quality, timeliness, cost, and compliant execution of the country clinical study portfolio.
What You Will Do
Provide strategic direction and leadership to LSOM country organization across the full study lifecycle, including feasibility, study execution, and study close-out. Establish portfolio-level oversight of delivery, quality, risk, timelines, and performance, directing timely escalation and resolution of critical issues for LSOM management organization.
Why It Might Be a Fit
The role requires a strong leader with experience in clinical research, project management, and influencing senior stakeholders. The ideal candidate will have a deep understanding of ICH GCP, ICH E6(R3), ICH E8(R1), and global regulatory expectations for risk-based monitoring and clinical trial oversight.
Requirements
- Doctorate degree and 4 years of clinical research experience
- Master's degree and 7 years of clinical research experience
- Bachelor's degree and 9 years of clinical research experience
- 4 years of direct managerial and/or leadership experience or equivalent
- Deep knowledge of ICH GCP, ICH E6(R3), ICH E8(R1), and global regulatory expectations for risk-based monitoring and clinical trial oversight
- Proven ability to influence senior stakeholders and lead complex cross-functional initiatives within a global matrix organization
- Strong Project Management experience
- Experience managing multiple teams / direct reports across multiple clinical functions / trials
- Experience at, or oversight of, clinical research vendors (CROs, central labs, imaging vendors, etc.)
- Experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials
Benefits
- Comprehensive employee benefits package
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models
]]>