Director (F/m/d) of Clinical Operations

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

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.

**Your role**:
**CRO & Vendor Oversight**
- You will lead the selection, contracting, and governance of CROs and key vendors.
- You will monitor performance against scope, timelines, budgets, and quality standards.
- You will act as the primary escalation point for operational issues.

**Study Execution**
- You will oversee all operational aspects of a multicenter Phase III trial: site selection, start-up, patient recruitment, monitoring, and close-out.
- You will ensure compliance with protocol, ICH-GCP, EU CTR, and internal SOPs.
- You build strong relationships with investigators and site staff.
- You will lead contract and budget negotiations with clinical sites.
- You will develop and coordinate training for study teams, sites, and vendors.
- You will collaborate with internal functions (Regulatory, Clinical Science, Data Management, Pharmacovigilance).

**Strategic & Cross-Functional Leadership**
- You will act as operational lead within the Clinical Study Team, partnering with the Medical Director.
- You will align trial operations with the Clinical Development Plan and company objectives.
- You will identify risks, implement mitigation strategies, and manage issues proactively.

**Budget, Compliance & Documentation**
- You will manage study budgets, CRO/vendor contracts, and financial tracking.
- You will oversee development and maintenance of essential study documents (protocol, IB, monitoring plan, CRFs, ICFs, CSRs).
- You will ensure TMF quality, inspection readiness, and regulatory compliance.
- You will support regulatory submissions and publications as needed.

**Internal Capability Building**
- You will contribute to SOP development and process improvements.
- You will provide operational input for future studies and patient-centric innovation strategies.

**Your expertise**:

- You have a Bachelor’s degree in Life Sciences or related field (advanced degree preferred).
- Several years of substantial Clinical Operations experience, including direct oversight of Phase II/III trials and several years of clinical operations line management experience.
- You have proven experience managing global CROs and clinical vendors as well as multi-country trials (Europe; US experience a plus).
- You demonstrate high proficiency in managing clinical studies with complex designs.
- You have expert knowledge of ICH-GCP, EU CTR, FDA/EMA regulations.
- You have a strong background in oncology trials (prostate cancer preferred); PET imaging-based trials experience is an advantage.
- You are a strategic thinker with excellent planning, problem-solving, and communication skills.
- You are fluent in English; additional European languages are an asset.
- You feel comfortable in a fast-paced, lean, mission-driven radiopharma environment.

To find out more about the specific business, have a look at Advanced Accelerator Applications Molecular Imaging - Siemens Healthineers

**Who we are**:
We are a team of more than 73,000 highly dedicated 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.

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