Department: Regulatory
Location: invoX Belgium N.V.
Description
Why This Role Matters
At invoX Respiratory Innovation Centre, we’re not just developing therapies; we’re reshaping the future of respiratory healthcare. In this role, you’ll be part of a close-knit, purpose-driven team dedicated to pioneering drug-device combination therapies. Every decision you make, every process you improve, and every study you oversee will help ensure patients receive safe, effective treatments.
As Clinical Operations Lead, you will be responsible for ensuring the efficient execution of clinical trials, maintaining GCP compliance, and overseeing operational processes to ensure high-quality study conduct. You’ll work closely with internal teams and external vendors, ensuring alignment with regulatory expectations and operational excellence.
This is a unique opportunity to gain broad exposure in a fast-growing organization. You’ll play a key role in clinical execution and quality oversight, shaping the way we run our studies while working at the intersection of clinical development, regulatory compliance, and operational excellence.
Position Overview
This is more than just a Clinical Operations Lead role—it’s an opportunity to take ownership of clinical trial execution and compliance in a growing, fast-paced biotech. You will oversee the conduct of clinical trials, working closely with CROs, vendors, and internal teams to ensure studies are executed efficiently and in full compliance with global GCP regulations.
The focus will be on pharmacokinetic bioequivalence (BE) trials and usability studies that align with US ANDA submission and EU MAA with MDR Article 117 (EU) regulatory pathways for drug-device combination products. These trials will support abridged regulatory applications, ensuring that our Soft Mist Inhaler (SMI) products meet regulatory and clinical expectations.
You’ll play a pivotal role in clinical trial oversight, process optimization, and quality assurance, ensuring that our studies are inspection-ready and that every aspect of our operations meets the highest regulatory and ethical standards.
If you thrive in a hands-on, execution-driven role where you can have a broad impact across clinical and regulatory operations, this is the perfect opportunity for you.
Why Join invoX?
At invoX, we believe in the power of innovation to change lives. By joining us, you’ll do purpose-driven work and be part of a collaborative community. We are a company delivering solutions that have the potential to improve lives worldwide.
Key Responsibilities
Clinical Trial Execution & Oversight
1. Oversee the operational execution of clinical trials for Soft Mist Inhaler (SMI) combination products.
2. Manage CROs, vendors, and study sites, ensuring smooth execution and adherence to timelines.
3. Implement risk-based study oversight, ensuring compliance with ICH-GCP, FDA 21 CFR Part 312, MDR 2017/745, and ISO 14155.
4. Support the development and execution of clinical study plans, ensuring alignment with the regulatory strategy (e.g., ANDA and MAA with Article 117).
5. Work with internal and external stakeholders (including regulatory, medical, and development teams) to ensure clinical operations align with overall project objectives.
6. Support the preparation of clinical trial applications (CTAs, INDs) and ethics committee submissions.
Clinical Quality & Compliance
1. Ensure Good Clinical Practice (GCP) compliance across all clinical trial activities.
2. Maintain and oversee Trial Master File (TMF) documentation, ensuring inspection readiness.
3. Conduct internal clinical audits and ensure the company is prepared for external regulatory inspections.
4. Oversee outsourced pharmacovigilance and safety reporting processes, working with commercial partners to ensure compliance.
5. Oversee compliance with MDR 2017/745 and ISO 14155, ensuring all drug-device combination studies adhere to regulatory requirements.
6. Implement and maintain quality control processes, ensuring that clinical operational activities align with best practices.
Cross-Functional Collaboration & Process Optimization
1. Work with cross-functional teams, including Regulatory, Quality and R&D, to ensure clinical activities support broader business and regulatory goals.
2. Provide operational input to ensure studies are designed and conducted efficiently.
3. Develop and maintain standard operating procedures (SOPs) for clinical operations.
4. Drive continuous improvement by identifying efficiency opportunities and implementing best practices in clinical execution.
Key Deliverables or Metrics of Success
Within the first 6 months, you will:
1. Establish clinical trial oversight mechanisms, ensuring study execution aligns with GCP and regulatory expectations.
2. Develop and implement quality assurance processes, ensuring compliance across all clinical operations.
3. Serve as the primary operational lead for clinical trial execution, managing key vendors and internal stakeholders.
4. Ensure study documentation is inspection-ready, implementing a robust approach to TMF management and compliance.
What You Need To Succeed
Education & Experience
1. Significant experience in clinical operations within the pharmaceutical or biotechnology industry.
2. Strong understanding of GCP, regulatory compliance, and clinical trial execution.
3. Experience with CRO oversight, vendor management, and clinical trial audits.
4. Familiarity with bioequivalence, pharmacokinetics, and usability studies is a plus.
5. Experience in managing compliance within a clinical operations environment.
Technical & Soft Skills
1. Project Management – Ability to oversee multiple studies, vendors, and stakeholders.
2. Attention to Detail – Strong focus on compliance, documentation, and regulatory expectations.
3. Problem-Solving – Ability to anticipate operational challenges and implement solutions.
4. Collaboration – Ability to work cross-functionally with Regulatory, Medical, and Product teams.
5. Communication – Clear and effective communication with CROs, vendors, and internal stakeholders.
What Sets invoX Apart?
1. Broad Exposure – Gain hands-on experience across multiple areas of clinical operations.
2. Purpose-Driven Work – Contribute to life-changing respiratory therapies.
3. Collaborative Environment – Work alongside a passionate, cross-functional team.
4. Flexibility – Hybrid working policy.
5. Fair Compensation – (discussed at the first interview).
Application Requirements
Candidates must be eligible to live and work in Belgium. We encourage applications from individuals of all backgrounds and experiences, as we strive to build a diverse and inclusive workforce. #J-18808-Ljbffr