Director Toxicology & ADME

Director Toxicology & ADME

ProQR Therapeutics

Leiden, Netherlands

ProQR is currently recruiting a Director Toxicology & ADME to join the Translational Development team, that works in a highly collaborative fashion with Discovery and Clinical Development on in vivo pharmacology studies, in vitro and in vivo safety studies, bioanalysis, pharmacokinetics and biomarkers. In your role, you will be reporting to the VP Translational Development.

The role:

ProQR is looking for a nonclinical subject matter expert with experience in GLP toxicology studies according to regulatory guidelines. The candidate will play an essential role in the determination and execution of nonclinical development programs. The successful candidate is an enthusiastic and creative team player and will work closely with other colleagues in an interdisciplinary team environment to progress translational science in ProQR’s programs.

The activities include:

• Develop the nonclinical pharmacology, pharmacokinetic and toxicology strategy to support progression of candidates from lead selection through clinical development;
• Represent translational development in project teams;
• Design in vivo studies for varying purposes including screening, proof-of-concept, PKPD relationship and safety according to regulatory guidelines;
• Interface with contract research organizations (CROs) from start to finish including managing slots, estimating costs, contracting, auditing, monitoring studies, reporting interim results, reviewing study plans and reports;
• Responsible for GLP studies;
• Integrated data analysis and interpretation across different studies but also across different disciplines;
• Write non-clinical safety assessments and dose justification for regulatory documents including regulatory advice requests and clinical trial applications;
• Evaluate or simulate dosing regimens in animal and early clinical studies to support dose regimen selection in the clinic;
• Ensure timeline and budget compliance.

Required qualifications:

• A PhD with more than 5 years of industry experience;
• Experience with toxicology studies (ICH), GLP and contributing to regulatory documents is essential (preferentially in the biotech/pharma industry);
• Knowledge and experience in nonclinical drug development;
• Experience with RNA therapeutics or other novel technologies is preferred;
• Team player, with a hands-on and can-do mentality;
• Flexible attitude, being able to work in a fast pace and dynamic environment;
• Pro-active and a pragmatic self-starter, with a result-oriented & problem-solving mindset.

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