Head of Clinical Quantitative Science

Head of Clinical Quantitative Science

ProQR Therapeutics

Leiden, Netherlands

Our Development department is currently looking for a highly motivated and experienced Head of Clinical Quantitative Science (Full-time) to join our team, who will report to our CMO and will drive the application of quantitative methodologies across our early clinical development programs. This role is integral to our decision-making process, integrating biostatistics, pharmacometrics, modeling & simulation, and big data analytics to support the design, analysis, and interpretation of clinical studies. The ideal candidate is a strategic thinker with a strong foundation in applied clinical quantitative sciences and a passion for innovation in drug development.

Key Responsibilities:

• Lead the clinical quantitative strategy for early-stage programs from first-in-human through proof-of-concept, focusing on biostatistics and data science to drive trial design and strategic decision-making;
• Design and implement innovative statistical methodologies (e.g., Bayesian, adaptive designs, enrichment strategies, dose-escalation models) to enhance the efficiency and scientific rigor of clinical trials;
• Analyze opportunities through disease modeling, including disease progression models, patient classification/clustering, biomarker integration, and the use of genetics, imaging, and real-world data to refine population selection and endpoint definition;
• Collaborate closely with clinical development, translational medicine, regulatory, and biomarker teams to integrate quantitative approaches across trial design and execution;
• Apply advanced statistical and data science methods (e.g., machine learning, real-world data analytics) to assess feasibility, trial outcomes, and development scenarios;
• Distinct from the PB/PKPD function, focus on clinical-level statistics, patient-level inferences, and disease-level modeling, rather than target engagement or species-level PK/PD translatability;
• Present quantitative findings to internal project teams, governance boards, and regulatory authorities, ensuring clarity and alignment with strategic goals;
• Maintain high standards of scientific rigor and regulatory compliance across all deliverables.

We expect our Head of Clinical Quantitative Science to have:

• PhD (or equivalent) in Biostatistics, Clinical Epidemiology, Applied Mathematics, Computational Biology, or related field;
• 8+ years of relevant experience in clinical development, with a strong track record in early-phase programs and data-driven clinical trial strategies;
• Extensive experience with statistical software and modeling tools (e.g., R, SAS, Python, Bayesian frameworks);
• Proven success in applying statistical models and trial simulations to support go/no-go decisions, trial design optimization, and regulatory interactions.

Skills and competencies that are required to make the difference:

• Deep understanding of the integration of biostatistics, pharmacometrics, and big data into clinical development;
• Strong communication and leadership skills with the ability to influence cross-functional teams;
• High level of scientific curiosity, strategic mindset, and attention to detail;
• Ability to manage multiple projects and priorities in a fast-paced environment.

Preferred Qualifications:

• Experience in therapeutic areas such as liver diseases or CNS.
• Background in AI/ML, digital biomarkers, or advanced classification/clustering approaches in clinical trials.
• Prior engagement with Health Authorities on clinical quantitative strategies and model-informed drug development (MIDD).

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