Country Head, Global Study & Site Operations at Amigen

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

20 May, 26

Salary

0.0

Posted On

19 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Execution, Study Strategy, Site Operations, Regulatory Compliance, Team Leadership, Portfolio Management, Feasibility Assessment, Site Selection, Resource Allocation, Site Engagement, Financial Management, Risk Management, Inspection Readiness, ICH-GCP, Vendor Oversight, Data Quality

Industry

Biotechnology Research

Description

Career Category Clinical Job Description At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. What you will do Let’s do this. Let’s change the world. 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 organizational objectives. Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles, working closely with global partners to match capacity and capability to portfolio demand. Drive site engagement through 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), representing the 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 4 years of clinical execution experience OR Master’s degree and 8 years of clinical execution experience OR Bachelor’s degree and 10 years of clinical execution experience In addition to meeting at least one of the above requirements, you must have at least 4 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: +10 years’ work experience in life sciences or medically related field, including 8 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. Join us and transform the lives of patients while transforming your career. Closing Date - Friday 27th February 2026 . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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Responsibilities

This role provides strategic and operational leadership for all clinical study and site execution within the assigned country or geography, ensuring delivery aligns with global strategies and quality standards. The incumbent is accountable for end-to-end execution, including start-up, enrollment, retention, data quality, and patient safety outcomes.