Clinical Operations Director (m/f/d) - Italy

Clinical Operations Director (m/f/d) - Italy

Join to apply for the Clinical Operations Director (m/f/d) - Italy role at Siemens Healthineers

Advanced Accelerator Applications, a Siemens Healthineers company, is a global leader in the production of PET radiotracers. With over two decades of expertise, we are committed to delivering high-quality, reliable diagnostic radiopharmaceuticals and services that have established us as a trusted partner in PET imaging.

As part of Siemens Healthineers Molecular Imaging business, we are integrated into a global network of 60 radiotracer production facilities. Siemens Healthineers is the largest supplier of PET diagnostic radiopharmaceuticals, delivering approximately two million doses annually to more than 3,100 imaging centers worldwide.

At Advanced Accelerator Applications, we believe in fostering an inclusive, diverse, and collaborative environment where every individual is valued. We encourage personal and professional growth, offering opportunities to step outside your comfort zone while providing the resources and flexibility to thrive. Join us to make a meaningful impact on global healthcare and be part of a team dedicated to shaping the future of medical imaging.

Apply now for the position of Clinical Operations Director and you will act as the key operational interface between internal stakeholders and external vendors, driving the trial from start-up through database lock. This position offers the unique opportunity to join a purpose-driven organization at the forefront of innovation in oncology diagnostics.

Your role

• You lead the selection, contracting, and oversight of CROs and vendors, ensuring performance aligns with quality, timelines and budget expectations.
• You oversee all operational aspects of multicenter Phase III trials, including site start-up, recruitment, monitoring, and close-out, in compliance with protocol, GCP, and regulatory standards.
• You act as operational lead within the Clinical Study Team, aligning trial execution with the Clinical Development Plan and company objectives.
• You manage trial budgets, contracts, and clinical documentation, ensuring inspection-readiness and regulatory support.
• You contribute to SOP development, process optimization, and innovation strategies for future trials and vendor governance.

Your expertise

• Bachelors degree in life sciences/healthcare is required. Advanced degree strongly preferred.
• 10+ years of clinical operations experience, including direct oversight of Phase II/III trials, and 4+ years of clinical operations line management experience.
• Expert in ICH GCP, EMA/FDA regulations with strong oncology background (prostate cancer); PET imaging experience is a plus.
• Strong strategic planning, problem solving and communication skills; proven stakeholders management and cross-functional collaboration.
• Experience in multi-country trials across Europe and the U.S.; fluent in English, other European languages are a plus; comfortable in fast-faced, lean environments.
• Willingness to travel up to 30% of the time.

Who we are

We are a team of more than 71,000 Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work

When you join Siemens Healthineers, you become part of a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We come from different backgrounds, cultures, religions, political and/or sexual orientations, and work together to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at Jobs at Siemens Healthineers.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Health Care Provider
• Industries: Medical Equipment Manufacturing, Hospitals and Health Care, and Biotechnology Research

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