Director Clinical Operations

ProQR Therapeutics

Leiden, Netherlands

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

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job