Head of Clinical Quantitative Science

Leiden, Zuid-Holland
Vast
Voltijds

2 maanden geleden

ProQR Therapeutics is a biotechnology company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, USA. ProQR is focused on the development of life changing RNA therapies to meet the unmet need of individuals and families with common and rare diseases. A team of 170+ enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the communities we serve. Our proprietary Axiomer® RNA editing technology platform enables the editing of specific single nucleotides in RNA using the cells own editing machinery. Axiomer® RNA editing technology harnesses ADAR (Adenosine Deaminase Acting on RNA), which is machinery present in all human cells to repair G-to-A mutations, modulate protein, and enable protective mutation functions. Axiomer could potentially yield a new class of innovative medicines and treat currently untreatable diseases.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.Location: Leiden, NLKey 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).

ProQR as an employerAs an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome things.We are committed to ensure that no employee, candidate, or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and valued.We offer an exciting and innovative working environment in a very committed organization, with the following benefits:

8% holiday allowance
30 vacation days
An annual performance bonus
Stock options
A premium-free pension plan
A commuting allowance
A subsidized staff restaurant
Unlimited (un)healthy snacks and drinks
Employee events (boot camp, Rebel Café and other social events)

Do you think you can contribute to achieving our mission? If so, we're looking forward to receiving your application by filling out our application form.You can contact Silvia Catellani via if you have any questions.

ProQR Therapeutics

Solliciteer