Clinical Trial Director*Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA.**At Flen Health, we focus on people with topical inflammatory and infectious diseases. Our vision is to shape a world, where wounds and skin disorders do not stop patients from living the life they love by developing innovative technologies and distributing them across the globe.**At Flen Health, we expect you to show grit, take ownership of your initiatives, to go for it and we guarantee that you will then appreciate the result of your work, whether individually, as a team or companywide as Flen Health. As an intrapreneur, you will enjoy working in a multicultural diverse environment where trust and open communication are key, and where a positive can-do attitude drives sustainable growth. We offer a flexible working ecosystem, enthusiastic colleagues, and an attractive remuneration package.*We are looking for a **Clinical Trial Director** for an immediate start. This is a permanent full-time position based in our office in Kontich and reporting directly to the CEO.As Clinical Trial Director, you will provide strategic, scientific, and operational leadership for clinical development programs across two major domains:1. European Medical Device Clinical Study: Leadership of a pan-European clinical trial evaluating a new version of Flaminal(R), ensuring high scientific quality, compliance with MDR and HTA.2. US Biopharmaceutical Development: Oversight of Phase 2 and Phase 3 clinical studies in the United States for VES Gel ensuring compliance with FDA and payers’ requirements.This position would suit you perfectly if you are driven by a desire to improve patients’ health and have the desire to make things happen.**Your responsibilities:**This role involves understanding the evidence requirements for reimbursement in key EU markets, such as clinical efficacy, comparative efficacy, evidence generation and economic evaluation standards applied by national and regional health technology assessment (HTA) bodies. The Clinical Trial Director must also be familiar with payer requirements for reimbursement of biopharmaceuticals for wound care in the United States and Europe to ensure that clinical development plans, evaluation criteria, and evidence provided are consistent with payer and insurer evaluation criteria and value-based criteria. This expertise will enable the design of studies that promote optimal market access, pricing and reimbursement outcomes for medical device and biopharmaceutical programs.**Strategic & Scientific Leadership**• Lead clinical strategy for the next-generation Flaminal(R) program and the VES Gel biopharmaceutical program• Ensure alignment with global development strategies and regulatory pathways**Clinical Trial Oversight**• Oversee all operational aspects of the European medical device study• Direct US Phase 2 and 3 studies for VES Gel• Manage CRO relationships and ensure quality and on-time delivery**Regulatory & Compliance**• Support submissions and interactions with Notified Bodies, HTA bodies, FDA and payers• Ensure compliance with ICH‐GCP, ISO 14155, MDR, FDA**Health Technology Assessment & Reimbursement Expertise**• Demonstrate strong familiarity with European Health Technology Assessment (HTA) processes and payer expectations both in Europe and the USA**Cross‐Functional Collaboration**• Partner with R&D, Quality, Medical Affairs, Market Access, and Manufacturing• Present progress to leadership**Team Leadership**• Lead internal and external clinical teams• Build scalable clinical operations capabilities**Your qualifications & experience:**• Advanced degree (MD, PhD, PharmD preferred)• 10+ years in clinical development, experience in wound care is a plus• Experience with European medical device studies and US Phase 2/3 trials• Excellent communication skills including verbal, written, and presentational• Strong organizational and planning skills• Strategic thinker with good negotiation skills• Working knowledge of, and ability to implement project activities in accordance with all applicable regulations and guidelines in the relevant regions• Ability to travel internationally• Ability to leverage scientific knowledge• Fluency in English (oral/written). All other language is an asset**What we offer:**• Excellent working conditions• An innovative and inspiring work environment• Independent project work & responsibilities within a professional team• Career prospect• Learning and development opportunities• Competitive remuneration according to experienceAccounting / FinanceAdministrative / ClericalBuilding / ConstructionManagementCommunicationsCreate / DesignCustomer Support / Client CareEngineeringFood ServiceHuman ResourcesInstallation / Maintenance / RepairIT / Software DevelopmentLegalLogistics / TransportationMarketing / ProductMedical / HealthProduction / OperationQuality Assurance / SafetyProject / Program ManagementR&D / ScienceSales / Business DevelopmentSecurity / Protective ServicesTraining / InstructionOther
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