Pharmacokinetic and Pharmacodynamic Modelling Expert

ProQR Therapeutics is a NASDAQ-listed biotechnology company headquartered in Leiden, the Netherlands with an office in and Cambridge, Massachusetts, USA.

At ProQR, we are on a mission to edit RNA, treat disease and change lives. A team of 180+ enthusiastic ProQRians from all walks of life and more than 30 different nationalities is committed to pioneering transformative RNA therapies 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), a protein which is 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. By harnessing the power of RNA editing, we aim to create a world where genetics inform your health - but never limit it.

We are currently recruiting an experienced or talented Pharmacokinetic and Pharmacodynamic modelling expert to join our Translational Development Team. The Translational Development Team works in a highly collaborative fashion on animal pharmacology, non-clinical development and clinical pharmacokinetic and biomarker analysis. Generation of quantitative PBPK/PKPD models are critically important for the successful progression of candidates to clinical development. Models will also integrate mechanisms of action for oligonucleotide therapeutics and their relation to target- and disease-specific biomarkers. In your role, you will be reporting to the VP Translational Development.

Location: Leiden, the Netherlands

The role:

ProQR is looking for a quantitative professional who will play a pivotal role in translatable dose predictions and pharmacodynamic biomarker-based decision-making across different programs. The model designs will be diverse and innovative, and data can come from in vitro, pharmacology, toxicology, bioinformatics and clinical studies. Hence, you will interact with different teams in ProQR across all stages of research and development. The successful candidate is an enthusiastic and creative team player and will work closely with other colleagues in an interdisciplinary team environment to progress the translational science in ProQR’s programs.

The activities include:

• Prepare mechanistic minimal PBPK and/ (population) PKPD M&S-based strategies to support discovery and development programs.
• Design, conduct and interpret these models to support drug screening and target validation, and to generate predictive (human) exposure profiles and to guide optimal dosing strategies and ensure therapeutic efficacy and safety.
• Drive learning through back-translation of exposure and pharmacodynamic data across different leads and targets. Review and integrate data sets across multiple disciplines.
• Author and/or review input for (population) PK/PD analysis components in regulatory documents, (non)clinical studies, statistical analysis plans or standalone PK/PD analysis plans, investigator brochures and scientific advice briefing books.
• Communicate modelling results and impact relating to the design of studies to project teams and represent PKPD modelling expertise in cross-functional teams and external collaborations.
• Interface with contract research organizations (CROs)
• Evaluate, integrate and develop innovative approaches to M&S-based strategies such as use of Machine Learning, Artificial Intelligence and systems pharmacology.
• Guide junior colleagues, mentor in PBPK/PKPD techniques and maintain required software and processes to state of the art.

Required qualifications:

• A candidate will have at least 4-8 years of working experience in pharmacokinetic/pharmacodynamic modelling and simulation, or 6-12 years of relevant experience, to qualify for a director position. Working experience will be judged on the diversity and complexity of modelling experience and leadership capabilities. Typically, the candidate will have an MSc in a quantitative field (such as mathematics, statistics, econometrics) or for biomedical/pharmaceutical professionals a PhD or MSc with additional working experience.
• MUST have hands-on experience with PK/PBPK/PKPD analysis and a proven track record to work with different modelling tools (e.g. NLME, Nonmem, Monolix, Matlab, PKsim/Mobi, Phoenix, QSP).
• Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and ability to evaluate, interpret and integrate large datasets and literature.
• Broad interest in different areas of drug development areas, such as molecular/cellular processes, disease biomarkers and interindividual patient variability.
• Have a keen interest in using new techniques and have an innovative attitude.
• Good written and oral communication skills in English.
• Team player, flexible attitude, problem-solving mindset.
• Pro-active and pragmatic self-starter, results-oriented.

ProQR as an employer

As an employer, we value a diverse workforce in which people are encouraged to develop themselves both personally and professionally. We believe that when people are happy, energized and supported by an environment in which they can thrive, they can achieve extraordinary things.

We are committed to ensuring 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 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, Coffee and Collaboration Café and other social events)

We are looking for people who are inspired by our mission to edit RNA, treat disease and change lives. Are you up for the challenge?

Submit your application via the Apply button below. Please contact Silvia Catellani via recruitment@proqr.com if you have any questions.

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