Director (f / m / d) of Clinical Operations - Inklusiver Job

Siemens Healthineers; München; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

A leading medical technology company is seeking a Director of Clinical Operations in Munich, Germany. This role involves overseeing the operational execution of Phase III clinical trials across Europe, ensuring compliance, managing budgets, and leading vendor relations. Suitable candidates possess a degree in Life Sciences and substantial experience in clinical operations, particularly in oncology. This position offers the chance to make a meaningful impact in the field of medical imaging.

Leistungen

Opportunities for professional growth

Inclusive and collaborative work environment

Qualifikationen

• Several years of substantial Clinical Operations experience, including oversight of Phase II / III trials.
• Experience managing global CROs and vendors.
• Expert knowledge of ICH-GCP, EU CTR, FDA / EMA regulations.

Aufgaben

• Oversee all operational aspects of a multicenter Phase III trial.
• Lead selection and governance of CROs and key vendors.
• Collaborate with internal functions like Regulatory and Data Management.

Kenntnisse

Leadership

Clinical Operations Management

Problem-solving

Communication

Fluency in English

Ausbildung

Bachelor's degree in Life Sciences or related field

Jobbeschreibung

Overview

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

Apply now for the position of Director (f / m / d) of Clinical Operations lead the operational execution of Phase III clinical trial, which will be conducted primarily across Europe. This role is critical in overseeing CRO and other vendors performance, ensuring scientific integrity, budget adherence, GCP compliance, and timeline delivery liaising timely with clinical science. 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.

Responsibilities

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.

How we work

When you join Siemens Healthineers, you become one in 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 are 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 https : / / www.siemens-healthineers.com / de / careers

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

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