Director Toxicology amp ADME
Director Toxicology amp ADME
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Salary Not Disclosed
1 Vacancy
Job Description
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 150 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 cells own editing machinery. Axiomer RNA editing technology harnesses ADAR (Adenosine Deaminase Acting on RNA) which is machinery present in all human cells to repair GtoA 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 aDirector 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 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 ProQRs 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 proofofconcept 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 nonclinical 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 handson and cando mentality
- Flexible attitude being able to work in a fast pace and dynamic environment
- Proactive and a pragmatic selfstarter with a resultoriented & problemsolving 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 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 their individual differences and contributions in all forms are recognized and valued.
We offer an exciting and innovative working environment in a very committed organization with the following benefits:
- 8% holiday allowance
- 30 vacation days
- An annual performance bonus
- Stock options
- A premiumfree pension plan
- A commuting allowance
- A subsidized staff restaurant
- Unlimited (un)healthy snacks and drinks
- Employee events (boot camp Hipster caf and other social events)
Do you think you can contribute to achieving our mission If so were looking forward to receiving your application.
You can contact Silvia Catellani via if you have any questions.
Employment Type
Full Time
