Pharmacokinetic and Pharmacodynamic Modelling Expert

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.

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 are true believers 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 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, 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 recruitment@proqr.com if you have any questions.