Assoc Dir Global Site & Study Operations

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Position: Associate Director Global Site & Study Operations Italy

What you will do

Lets do this. Lets change the world.
Provide strategic and operational leadership for all study and site execution within the assigned country 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 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 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 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 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.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• Generous Total Rewards Plan comprising health finance and wealth work/life balance and career benefits
• A discretionary annual bonus program or for field sales representatives a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models including smart-working arrangements where possible
  

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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 and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

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 disability status or any other basis protected by applicable law.