Description
EHULX-KQFP2-P9LYM
Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography, ensuring delivery of the clinical portfolio in alignment with global study strategies, regulatory requirements, and Amgen quality standards.
+ **Accountable for end-to-end study, site, and site engagement execution** across the assigned country or hub-and-spoke geography, delivering start-up, enrolment, retention, data quality, and patient safety outcomes in compliance with local regulations and global strategies.
+ **Provide strategic leadership for country commitments** , acting as a key advisor on study feasibility, placement, and site selection, aligned to global portfolio priorities and regional strengths.
+ **Lead, line-manage, and develop the Country/Hub team** , ensuring clear direction,strong performance, capability development, and succession planning to deliver portfolio and organizationalobjectives.
+ **Ensure adequate and** **timely** **resourcing** across study delivery, site operations, andmonitoringroles, working closely with global partners to match capacity and capability to portfolio demand.
+ **Drive site** **engagement** **t** **hrough** **a clearly differentiated Amgen site experience**
+ strengthening investigator and site relationships through strong leadership, compliance, innovation, and collaboration with global study teams.
+ **Oversee country-level financial and operational management** , including budgets, forecasting, vendor oversight, and efficient allocation of resources to ensure accountability and value delivery.
+ **Lead country governance and risk management** , including chairing the Country Management Team (CMT),representingthe country in senior governance forums, and managing risks, issues, and escalation to protect quality and delivery.
+ **Ensure regulatory compliance, inspection readiness, and continuous improvement** , promoting best-practice sharing, audit readiness, and adherence to ICH-GCP, SOPs, and local regulatory requirements.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications.
**Basic Qualifications:**
+ Doctorate degree and 3 years of clinical execution experience OR
+ Master’s degree and 7 years of clinical execution experience OR
+ Bachelor’s degree and 9 years of clinical execution experience
+ In addition to meeting at least one of the above requirements, you must have at least 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
**Preferred Qualifications:**
+ +8 years’ work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
+ Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
+ Significant experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
