Directeur des opérations cliniques (f/h/nb)

Siemens Mobility; Saint-Genis-Pouilly; Hybride; EUR 80 000 - 120 000; Plein temps

Résumé du poste

A global healthcare innovation leader is seeking a Director of Clinical Operations based in Saint-Genis-Pouilly, France. This role involves leading a Phase III clinical trial, managing CROs, and ensuring compliance with regulatory standards. The ideal candidate will have over 10 years of experience in clinical operations and a background in life sciences. Opportunities for telework and travel across Europe will be available.

Prestations

Flexible work hours

Opportunities for professional growth

Qualifications

• 10+ years of clinical operations experience, including Phase II/III trials.
• Proven success in managing global CROs and clinical vendors.
• Fluency in English; other European languages are an asset.

Responsabilités

• Lead the management of a Phase III clinical trial in Europe.
• Ensure adherence to study protocol, ICH-GCP guidelines, and regulatory requirements.
• Oversee trial budget management and compliance.

Connaissances

CRO and Vendor Oversight

Study Execution

Strategic & Cross-Functional Leadership

Budget Management

Compliance and Documentation

Internal Capability Building

Formation

Bachelor’s degree in life sciences/healthcare

Advanced degree

Description du poste

English version

Join us in healthcare innovation. For everyone. Wherever they are. Durably.

Our inspiring and caring work environment promotes diversity and individuality. We encourage you to be your best by providing resources and flexibility to support your professional and personal growth, while valuing your performance.

Advanced Accelerator Applications Molecular Imaging, a Siemens Healthineers company, is a global leader in the production of PET radiotracers. With more than two decades of expertise, we provide reliable, high-quality radiopharmaceuticals and diagnostic services and serve as a trusted partner in PET imaging. As part of Siemens Healthineers’ molecular imaging business, we are in a global network of 60 radiotracer production sites. Siemens Healthineers delivers about two million doses per year to more than 3,100 imaging centers worldwide.

We foster an inclusive, diverse, and collaborative environment where every individual is valued. We support personal and professional growth, offering opportunities to step out of your comfort zone with resources and flexibility to thrive. Join us to make a meaningful impact on global healthcare and be part of a team shaping the future of medical imaging.

Location: Mainly at ADAC MI headquarters in Saint-Genis-Pouilly (01) with the possibility of teleworking and travel in Europe.

Your role:

You are an experienced, agile leader passionate about operational excellence. Join us as Director of Clinical Operations and lead the management of a Phase III clinical trial, primarily conducted in Europe.

You will supervise CRO and partner performance, ensure scientific integrity, budget adherence, GCP compliance, and timely delivery while collaborating closely with scientific teams.

You will act as the essential link between internal stakeholders and external vendors, from trial start-up to database lock.

This mission offers a unique opportunity to contribute to a visionary organization at the forefront of oncology diagnostics.

Your expertise:

1. CRO and Vendor Oversight
2. Lead selection, contracting, and oversight of the CRO and major vendors.
3. Ensure vendor performance aligns with scope, timelines, budgets, and quality expectations.
4. Serve as the primary escalation point for operational challenges.

1. Study Execution
2. Oversee the operational implementation of a multicenter Phase III trial, including site selection, start-up, patient recruitment, data collection, monitoring, and close-out.
3. Ensure adherence to study protocol, ICH-GCP guidelines, regulatory requirements, and internal SOPs.
4. Collaborates with Clinical Development to engage investigators and site personnel.
5. Leads contract and budget negotiations with clinical trial sites to align with study objectives and timelines.
6. Leads the development and coordination of training for study teams, sites, and vendors to ensure consistency, compliance, and readiness.
7. Coordinate with internal stakeholders (regulatory, clinical science, data management, pharmacovigilance).

1. Strategic & Cross-Functional Leadership
2. Act as the operational lead within the Clinical Study Team, partnering with the Medical Director/Clinical Science Lead.
3. Align trial operations with the Clinical Development Plan and strategy, and company goals for regulatory approvals, reimbursement, and lifecycle management.
4. Identify risks, develop mitigation plans, and manage issues with urgency and transparency.

1. Budget, Compliance, and Documentation
2. Oversee trial budget management, CRO/vendor contracts, change orders, and invoice reconciliation. Liaise with the finance team for financial insights.
3. Oversee development and maintenance of key study documents (protocol, IB, monitoring plan, manuals, CRFs, ICFs, CSR).
4. Ensure monitoring activities are thorough and compliant with SOPs, GCP, regulatory requirements, and company standards, including training internal and external teams.
5. Ensure inspection readiness and TMF/site documentation compliance.
6. Support regulatory filings and publications as needed.

1. Internal Capability Building
2. Contribute to SOP development and cross-functional processes to support trial operations and vendor governance.
3. Provide operational insight for future studies and patient-centric innovation strategies.

Your profile:

Education & Experience

• Bachelor’s degree in life sciences/healthcare (or clinically relevant degree) required. Advanced degree strongly preferred.
• 10+ years of clinical operations experience, including direct oversight of Phase II/III trials and at least 4 years of management experience.
• Proven success in managing global CROs and clinical vendors.
• Experience in multi-country trials across Europe; US experience is a plus.

Technical & Leadership Skills

• Expert knowledge of ICH-GCP, EU Clinical Trial Regulation, FDA and EMA environments.
• Strong ability to manage clinical studies with complex designs.
• Extensive knowledge of oncology trials with focus on prostate cancer. PET imaging trial experience is a plus.
• Strong strategic thinking, operational planning, and problem-solving.
• Excellent verbal and written communication. Stakeholder management and cross-functional collaboration skills.
• Fluency in English; other European languages are an asset.
• Comfortable in a fast-paced radiopharmaceutical environment.

Diversity, Equity & Inclusion

We are committed to EDI values and study all candidacies with transparency.

Need help applying?

Recruitment Lead: Delphine REI

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Who we are:

Siemens Healthineers’ innovative solutions portfolio enables clinical decision-making and patient care. We are a global team of 72,000 colleagues in 70+ countries driving health innovation to improve lives.

Our way of working:

By joining Siemens Healthineers, you become part of a global team united by the belief that each individual can contribute meaningfully through diverse ideas. We come from diverse backgrounds and work together to fight disease and increase access to care, with a shared ambition: shape health innovation. For everyone. Wherever they are. Durably.

Find our Careers site at

https://www.siemens-healthineers.com/fr/careers

We are an equal opportunity employer and welcome applicants with disabilities.

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Join us in healthcare innovation. For everyone. Wherever they are. Durably.