Director Clinical Operations
4 dagen geleden
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 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.
We have several programs in early-stage development as part of our Axiomer RNA editing platform. Our way of working involves a combined approach of in-house expertise and fully outsourced GxP Activities. We are currently looking for a **Director Clinical Operations (DCO, Full-time)**to build our clinical operations capacity. The aim of the position is to structure the clinical operations department and managing the team of clinical operations leaders. The DCO will provide strategic and technical leadership to ensure that clinical trials are properly planned and executed, to ascertain appropriate selection of clinical CROs and other clinical vendors and to drive engagement, development, retention and adequate resourcing of the Clinical Operations team.
The DCO will be a key member of the cross functional project teams to support definition of the clinical development strategies with a high chance of successful outcomes and good quality results, in a highly dynamic and complex environment and in accordance with the appropriate quality standards including GCP/ICH requirements and applicable international and local regulations.
As the DCO is the founder of this department within the ProQR organization, we expect the DCO to lead the first-in-human study for the first clinical target from the proprietary Axiomer Platform in a fully outsourced model.
**Key Responsibilities**:
**Strategic planning and execution of clinical trials**
- Develop strategic plans for clinical trials and ensure alignment with corporate goals, GCP, regulatory requirements, quality standards.
- Clinical study planning including site selection, vendor selection, patient recruitment and site engagement
- Report on status and risks to key stakeholders
**Clinical study oversight**
- Lead the operational execution of the first in human clinical study
- Oversee & manage operational execution of development clinical trials and ensure execution in line with strategic plans and budget
- Manage timelines, budgets, CRO partnerships, and key stakeholder communications to ensure efficient trial execution
**Strategic Team Building**
- Develop and execute a plan to build and scale the clinical operations team in line with the company’s objectives.
- Recruit and mentor the clinical operations staff to support future clinical programs
**Operational Excellence**
- Build on processes, tools, and systems to enhance operational efficiency and data quality
- Collaborate cross-functionally with regulatory, CMC, and preclinical teams to advance clinical programs seamlessly
**Leadership Development**
- Act as a hands-on leader initially, gradually transitioning into a broader strategic leadership role as the team grows
- Contribute to long-term development planning
**Requirements**:
**Experience**:
- 10+ years of experience in clinical operations, including a proven track record in managing (early-phase) clinical trials
- Excellent understanding of GCP, clinical trial methodology, clinical trial execution and ICH and regulatory requirements
- Experience in biotechnology and/or pharmaceutical setting, with expertise across all stages of Clinical Development
**Leadership Skills**:
- Demonstrated ability to lead cross-functional teams and manage external partners (e.g., CROs)
- Able to recognize needs, find solutions and take initiative in a pro-active manner
- Self-starter with a strong strategic vision and hands-on operational expertise
**Education**:
- Bachelor’s degree in life sciences or a related field (advanced degree preferred).
**Other**:
- Excellent organizational, project management and problem-solving skills
- Effective verbal and written communication skills (in English) with colleagues, leadership with external stakeholders
**Location**: Leiden, NL
**Skills and competencies that are required for making the difference**:
- Analytical and accurate
- Creative thinker
- Flexible and resistant to change
- Hands-on mentality
- Pro-active attitude
- Teamplayer
- Patient
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