(Senior) Director Clinical Operations

(Senior) Director Clinical Operations

ProQR Therapeutics

Leiden, Netherlands

About the role:

As (Senior) Director Clinical Operations, you will combine strategic leadership with hands-on execution. You will be responsible for designing, building, and leading the clinical operations function, while directly overseeing early-phase clinical trials.

This role requires someone who thrives in a fast-paced, evolving environment, where priorities may shift and ambiguity is part of the journey. You are comfortable rolling up your sleeves while also stepping back to shape long-term strategy.

You will play a key role in cross-functional teams, contributing to clinical development strategies and ensuring high-quality execution aligned with GCP/ICH and global regulatory standards.

What you will do:

• Lead the strategic planning and execution of clinical trials, including first-in-human studies;
• Build and scale the clinical operations function, including team development and resourcing;
• Oversee CROs and vendors, ensuring high-quality and efficient trial delivery;
• Drive patient-centric trial design and recruitment strategies;
• Manage timelines, budgets, risks, and stakeholder communication;
• Establish and improve processes, tools, and systems to enhance operational excellence;
• Collaborate cross-functionally with regulatory, CMC, and preclinical teams;
• Act as a hands-on leader, while shaping the long-term strategic direction of the function.

What we are looking for:

Experience:

• 10+ years in clinical operations, including early-phase clinical trials;
• Strong knowledge of GCP, ICH, and global regulatory requirements;
• Experience in biotech environments;
• Proven experience managing CROs and external vendors.

Leadership & mindset:

• Thrives in a fast-paced, dynamic environment where priorities can shift;
• Hands-on and pragmatic, yet able to zoom out and think strategically;
• Creative and able to think beyond conventional approaches;
• Comfortable exploring new, unpaved territory;
• Proactive and solution-oriented;
• Balances structure with flexibility in an evolving organization.

Skills:

• Strong project management and organizational skills;
• Excellent communication and stakeholder management;
• Analytical mindset with strong problem-solving capabilities;
• Ability to prioritize effectively across multiple initiatives;
• Fluent in English (written and spoken).