Director Toxicology

7 dagen geleden


Leiden, Nederland ProQR Therapeutics Voltijd

**Director Toxicology & ADME**

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 120 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 cell’s 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.

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.

**Location**: Leiden, NL

**The successful applicant will be required to commute to our Leiden office at least three days every working week.**

**The role**:
The activities include:

- 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
- 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

**ProQR as an employer**

As an employer, we are a true believer 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 offer an exciting and innovative working environment in a very committed organization, with the following benefits:

- A competitive salary
- 8% holiday allowance
- 30 vacation days
- An annual performance bonus
- Stock options
- A premium-free pension plan
- A commuting allowance
- A subsidized staff restaurant
- Flexible working arrangements
- Unlimited (un)healthy snacks and drinks
- Employee events (boot camp, Hipster café and other social events)
- Please note that a screening stage is a part of our selection procedure._