Director Toxicology

ProQR Therapeutics

Leiden, Netherlands

The role:

ProQR is looking for an experienced Director Toxicology to join the Translational Development team and to provide scientific and strategic leadership for the nonclinical safety assessment of our pipeline. In this role, you will define and execute toxicology strategies that enable the progression of innovative RNA therapeutics from discovery through clinical development.

As Director Toxicology, you will work across multidisciplinary project teams and collaborate closely with external partners to ensure robust, science-driven safety packages that support regulatory submissions worldwide. You will play a key role in shaping development strategies while ensuring studies are delivered to the highest scientific, regulatory, and quality standards.

The activities include:

Lead the nonclinical toxicology strategy across multiple research and development programs, ensuring alignment with program objectives and timelines as well as regulatory expectations;
Provide scientific leadership for the design, execution, oversight, and interpretation of nonclinical safety studies, including GLP toxicology studies conducted at contract research organizations (CROs);
Develop integrated nonclinical safety packages that support candidate selection, IND/CTA-enabling activities, and clinical development;
Serve as the toxicology expert on cross-functional project teams, contributing to development strategy, risk assessment, and decision-making;
Oversee external CROs, including study planning, protocol review, monitoring of study progress, budget management, and timeline adherence;
Critically review study protocols, reports, and datasets, ensuring high-quality interpretation and integration of pharmacology, toxicology, pharmacokinetic, and biomarker data;
Contribute to the preparation of regulatory documents, including Investigator's Brochures, CTA/IND submissions, briefing packages, and responses to health authority questions;
Stay current with evolving regulatory guidance and scientific advances in toxicology and RNA therapeutics, translating new insights into development strategies;
Build strong collaborations across Research, Translational Development, Clinical Development, Regulatory Affairs, CMC, and external scientific experts;
Mentor and guide junior scientists, providing scientific expertise, technical coaching, and support for their professional development within a collaborative research environment.

Required qualifications:

PhD (or equivalent) in Toxicology, Pharmacology, Veterinary Medicine, or a related life sciences discipline;
Extensive pharma and/or biotech experience in nonclinical drug development, including leadership of toxicology programs supporting clinical development;
Deep expertise in the design, conduct, interpretation, and regulatory application of GLP toxicology studies and broader nonclinical safety assessment;
Strong understanding of ICH guidelines and global regulatory expectations for nonclinical safety packages;
Experience contributing to or leading regulatory submissions (INDs, CTAs, IBs, briefing documents, responses to health authorities);
Experience working with oligonucleotide therapeutics, RNA-based medicines, gene therapies, or other advanced therapeutic modalities is highly desirable;
Demonstrated ability to influence cross-functional teams and provide strategic scientific guidance in a collaborative environment;
Excellent project management skills, with experience managing external CROs, budgets, and timelines;
Strong communication and stakeholder management skills, with the ability to translate complex scientific data into clear development recommendations;
A proactive, pragmatic, and solution-oriented mindset, with a passion for advancing innovative therapies for patients.