Pharmacokinetic and Pharmacodynamic Modelling Expert

Pharmacokinetic and Pharmacodynamic Modelling Expert

ProQR Therapeutics

Leiden, 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.

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