Country Head, Global Study & Site Operations

Amgen

Not Interested
Bookmark
Report This Job

profile Job Location:

Shanghai - China

profile Monthly Salary: Not Disclosed
Posted on: 2 days ago
Vacancies: 1 Vacancy

Job Summary

Career Category

Clinical Development

Job 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 andAmgen quality standards.

  • Accountable for end-to-end study site and site engagement executionacross 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 directionstrong performance capability development and succession planning to deliver portfolio and organizationalobjectives.

  • Ensure adequate andtimelyresourcingacross study delivery site operations andmonitoringroles working closely with global partners to match capacity and capability to portfolio demand.

  • Drive siteengagementthrougha 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
  • Masters degree and 7 years of clinical execution experience OR
  • Bachelors 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 (CROs 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 well support your journey every step of the way.

.
Career CategoryClinical DevelopmentJob DescriptionEHULX-KQFP2-P9LYMProvide 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 req...
View more view more

Key Skills

  • Home Care
  • F&B
  • Learning Management System
  • HVAC Design
  • Airlines

About Company

Company Logo

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 ... View more

View Profile View Profile