Director Toxicology

ProQR Therapeutics; Leiden; On-site; EUR 140,000 - 180,000; Full time

Benefits offered by this job

8% holiday allowance

30 vacation days

Annual performance bonus

Stock options

Pension plan

Commuting allowance

Staff restaurant

Unlimited snacks and drinks

Employee events

Job summary

ProQR Therapeutics in Leiden, NL is seeking a Director Toxicology to lead nonclinical safety for the Translational Development portfolio. Location: Leiden, on-site.

The role defines toxicology strategies, coordinates GLP safety studies with CROs, and supports candidate selection and IND/CTA enabling activities. A PhD in a life sciences discipline and biotech experience are required.

Qualifications

• PhD in Toxicology, Pharmacology, Veterinary Medicine, or a related life sciences discipline.
• Extensive pharma/biotech experience in nonclinical drug development.
• Expertise in 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 with oligonucleotide therapeutics or RNA-based medicines is highly desirable.
• Demonstrated ability to influence cross-functional teams and provide strategic scientific guidance.
• Excellent project management skills, with experience managing external CROs, budgets, and timelines.
• Strong communication and stakeholder management skills.

Responsibilities

• Lead the nonclinical toxicology strategy across multiple research and development programs.
• Provide scientific leadership for design, execution, oversight, and interpretation of nonclinical safety studies (GLP).
• Develop integrated nonclinical safety packages to support candidate selection and enabling activities.
• Serve as the toxicology expert on cross-functional project teams and guide development strategy.
• Oversee external CROs, including budgeting, timelines, and study progress monitoring.
• Critically review study protocols, reports, and datasets for integrated interpretation.
• Contribute to regulatory documents (INDs, CTAs, IBs, briefing packages, responses).
• Stay updated with regulatory guidance and advances in toxicology and RNA therapeutics.
• Build collaborations across Research, Translational Development, Clinical Development, Regulatory Affairs, CMC, and external experts.
• Mentor and guide junior scientists in a collaborative environment.

Skills

Toxicology leadership

GLP toxicology

Regulatory strategy

Project management

Cross-functional collaboration

Communication of complex data

Education

PhD in Toxicology, Pharmacology, Veterinary Medicine, or related life sciences

Job description

ProQR Therapeutics is a NASDAQ-listed biotechnology company headquartered in Leiden, the Netherlands with an office in 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 cell’s 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.

To strengthen our Axiomer Unit, we are looking for a Director Toxicology (full-time) to support our Translational Development portfolio. Location: Leiden, NL (on-site).

The role

ProQR is looking for an experienced Director Toxicology to join the Translational Development team and 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.

Key responsibilities

• 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 passion for advancing innovative therapies for patients.

ProQR as an employer

We value a diverse workforce in which people are encouraged to develop themselves both personally and professionally. 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 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 snacks and drinks
• Employee events (boot camp, coffee and collaboration café and other social events)

Please contact Silvia Catellani via [e-mail] if you have any questions.