Director, Translational Biomarker Lead

 
Place in the Organization
 
At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients.  Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments. 
 
Position Overview
The Director, Translational Biomarker Lead will take full responsibility for defining and implementing biomarker strategies across all research programs at uniQure. The Director, Translational Biomarker lead will assume a pivotal role in Research Project Teams, across different modalities and disease indications, and consult with early clinical development teams to ensure translation of biomarker strategies across our portfolios.
 
The department of Non-clinical Development & Bioanalytics supports the development of gene therapy programs (gene silencing and replacement, editing) up to and beyond IND/CTA. The department supports project teams with experts in toxicology, large animal biodistribution, bioanalytical assays and as well as biomarker strategy and development.
 
Location: The role is to be placed in Amsterdam, The Netherlands.
 
Key result areas (major duties, accountabilities and responsibilities):  
 

• Develop a comprehensive scientific strategy and operational plan for the biomarker development initiated in the preclinical stage to serve the pipeline projects in uniQure.
• Expertise in neuroscience but not exclusively 
• Oversee the design and development of biomarker methods suitable for (pre)clinical activities, liaising closely with early clinical development for future translation to patients.
• Identify, oversee and manage third parties for outsourced activities (e.g., CRO). 
• Secure that the activities are completed within set timelines and budget.
• Establish and formalize collaborations with key opinion leaders, with focus on enhancing biomarker development strategies and leveraging external expertise.
• Collaborate closely with cross-functional teams, including Clinical development, Manufacturing, and external partners such as CROs and academic collaborators, to drive cohesive and efficient project advancement.
• Stay at the forefront of scientific and technological innovation by evaluating emerging methodologies and platforms, proactively introducing new approaches to strengthen translational and preclinical research strategies.
• Writes, reviews and/or approves study plans and reports, and, if applicable, patents, articles and/or other documentation (e.g., regulatory).

 
Qualifications & Skills
 

• Ph.D. in Neurobiology or a related field with translational experience in CNS drug discovery. Experience in Huntington’s disease or other neurodegenerative disease would be seen as a plus.
• Minimum 5 years industry experience in drug development with responsibilities in biomarker development, either preclinical or clinical.
• Extensive knowledge of design and execution of antibody-based assays (e.g., ELISAs, MSD and SMC platforms) and analytical assays (mainly LC-MS) for biological matrices (CSF, blood, and tissues) in both pre-clinical and clinical settings.
• Strong scientific acumen with the ability to lead experimental design and derive meaningful insights from complex datasets (e.g., Omics).
• Effective organizational skills with the ability to manage multiple tasks, meet deadlines, and work both independently and collaboratively in a fast-paced environment.
• Demonstrated success in collaborating with cross-functional teams and external partners, including CROs and academic institutions.
• Familiarity with the regulatory approval process.
• Solid ability to present to colleagues and senior management.
• Excellent verbal and written communication skills in English.