Lead Clinical Studies and Logistics

We are currently seeking a Lead Clinical Studies and Logistics to join our “Clinical Development and Regulatory Affairs” team.

As our Lead Clinical Studies and Logistics, you will be responsible for planning, executing, maintaining oversight and report on clinical trials, from planning, vendor selection (if applicable) and site feasibility, through study close out.

You will play an active role in accomplishing our goals and in our company’s success.

Your responsibilities will be:

• To lead and provide direction to the cross-functional Study Management Team (SMT) to ensure all trial outputs from protocol development to final clinical study reports are delivered on time, within budget, and with high quality, in adherence to internal SOPs, GCP and applicable regulatory guidelines;
• To build strong relationships with internal and external stakeholders;
• To understand from a scientific, biological and clinical angle the needs of the scientific community and defines the product specifications in terms of expected clinical outcomes. This to support correct medical decisions, based on proven and novel breakthrough-technology diagnostic tests;
• To develop and coordinate the development and approval of study documentation such as the study protocol, ICF, study-specific guidelines, regulatory documents, monitoring, data management and statistical analysis plans and clinical study reports, in accordance with internal SOPs and GCP requirements;
• To define and drive study timelines and milestones;
• To oversee study approval processes for the Health Authority, EC/IRB approvals for all study documents as required;
• To oversee forecasting of study supplies ;
• To review and approve feasibility;
• To address enrolment and retention issues, identifying and implementing actions to keep studies on track;
• To ensure proper study documentation is maintained;
• To build a strong international network of KOLs and patient advocacy groups: understand the needs, gains new ideas and is able to challenge the current way of working to test and try new things;
• To maintain broad medical, clinical, and scientific knowledge of IVD diagnostic technologies and applications;
• To keep abreast of industry trends and identifies opportunities.

• PhD degree in molecular biology, biochemistry or related disciplines;
• Minimum 3 years of industrial experience in clinical research or molecular diagnostics;
• Experience with IVD development and knowledge of regulatory context (IVDR and FDA) and intellectual property is required;
• Experience with molecular detection technologies (PCR, LAMP, NGS) is a strong plus; 
• Expertise in design of experiments and statistical data analysis;
• Fluent in English (written and spoken); Knowledge of Dutch is an asset;
• Scientific and technology background in diagnostics, deep understanding of Clinical Laboratory practices;
• Expert knowledge in Infectious Diseases, flexibility to dive sporadically in other therapeutic areas;
• Solid record of developing and maintaining successful relationships with opinion leaders and investigators in various areas;
• Ability to thrive and deliver in a fast-paced, dynamic and highly multi-tasking environment;
• Strong organizational skills, proactivity, scientific curiosity with keen interest in novel technologies for molecular diagnostics;
• Strong communicator and planner: proven experience with steering cross-functional and self-steering teams;
• Manage third party collaborations and scout for new technologies and partners;
• Demonstrated innovative, critical thinking and problem-solving skills;
• Ability to translate scientific and clinical input from diverse fields into product requirements;
• Ability to drive decision-making within a multi-disciplinary and entrepreneurial team:
• Excellent interpersonal skills, including the ability to influence others
• Significant degree of autonomy
• Entrepreneurial mindset
• Team player, enthusiastic, accurate in execution and reporting;
• You feel comfortable in a start-up environment and you can easily switch from one task to another;
• You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues;
• Our offices are located in Leuven (Belgium). Relocation to Belgium is needed. It is essential that you hold entitlement to work and live in Belgium.