Director, Clinical Operations

uniQure; Amsterdam; On-site; EUR 150,000 - 210,000; Full time

Job summary

uniQure in Amsterdam seeks a Director of Clinical Operations to drive end-to-end program success, aligning with the Head of Clinical Operations to ensure top quality, timelines and budgets. The role requires strong leadership across cross-functional teams and experience with international trial management.

Responsibilities include feasibility, enrollment strategies, site management, budgeting, risk mitigation, and regulatory interactions with FDA/EMA.

Qualifications

• Bachelor’s degree required; advanced degree preferred; medical related degree preferred.
• 10+ years of experience in biotech/pharma or clinical CRO.
• 8+ years in clinical trial management and international projects.

Responsibilities

• Lead end-to-end clinical development programs and ensure quality, timelines, and budget goals.
• Oversee feasibility, enrollment strategies, and site management activities.
• Manage budgets, resources, and cross-functional team effectiveness.
• Lead regulatory interactions with FDA/EMA and ensure data integrity.
• Mentor and develop Clinical Operations staff; foster accountability and collaboration.
• Establish CRO/vendor relationships and monitor performance.

Skills

Clinical Ops Leadership

Project Management

Budget Management

Regulatory Knowledge

Global Team Leadership

Vendor Management

Regulatory Submissions

Education

Bachelor's degree

Advanced degree preferred

Job description

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.

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, Clinical Operations serves as the program Chief Operating Officer, accountable for end-to-end program success, ensuring top quality, timelines, and budget goals are met. Working closely with the Head of Clinical Operations to ensure project teams are well structured, resourced, and equipped with all the tools needed to deliver.

Major Duties, Accountabilities And Responsibilities

Strategy & Leadership

• Lead the integration of clinical development, quality, regulatory, and operations aspects into an ambitious project plan
• Manage resource planning and hiring in collaboration with the Head of Clinical Operations. Ensure the project team has the knowledge and tools needed to drive a successful project
• Mentor, coach, and develop Clinical Operations team members; foster a culture of accountability, collaboration, and continuous learning
• Stay up to date with relevant therapeutic areas, industry developments, and competitors, clinical and regulatory practices and ensure the project team is enriched with relevant learnings
• Build effective relationships with the cross-functional teams, enabling each function to optimally contribute to the success of the program
• Build superior relationships with investigators in support of uniQure mission to become Sponsor of Choice

Clinical Trial Management

• Lead the feasibility assessments for new protocols, including site and country feasibility and patient population analysis
• Lead the development of best fit for purpose enrollment modalities, reflecting the target population and unique patient journey per indication
• Oversee clinical site management activities including site initiation, monitoring visits, and close-out
• Build and monitor project-level budget, resources, and timelines in collaboration with the global project manager and program lead
• Identify project risks, develop and implement mitigation strategies in partnership with the cross functional team
• Ensure project team members are appropriately informed and trained on project-related processes

Vendor Management

• Lead vendors selection in accordance with the business and operating model chosen for the program
• Establish performance indicators and apply them to ensure the successful execution of clinical trials to agreed timelines
• Develop and maintain strong relationships with CROs and other major vendors, driving optimal performance and ability to effectively solve emerging delivery gaps

Quality & Compliance & data

• In partnership with clinical QA, implement inspection readiness measures in each step and modality of the program; provide direction to ensure proper compliance with company SOPs, ICH-GCP guidelines and regulatory authority regulations
• Provide support for regulatory submissions, support dossier development, and participate in interactions with FDA, EMA, and other regulatory agencies
• Collaborate with Clinical Data Management, Biometrics and Medical writing to coordinate end to end data flow elements
• Contribute to the development, review, and continuous improvement of departmental SOPs and operational processes to drive efficiency, consistency, and best practices across Clinical Operations

Qualifications & Skills

• Bachelor’s degree required; advanced degree preferred; medical related degree preferred
• 10 or more years of relevant experience in biotech, pharmaceutical or relevant clinical CRO, including 8+ years in clinical trial management
• Experience in complex international clinical research projects and early drug development
• Demonstrated leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building
• Excellent project management skills and ability to drive continues process improvement
• Experience in the budget and forecast management of clinical trials
• Strong experience and understanding of all clinical development modalities and ability to coordinate all aspects across a clinical study data flow
• Current knowledge of ICH-GCP, EU CT Directive and FDA regulations. Prior experience in Gene Therapy trials is preferable

uniQure is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, veteran or military status, or any other characteristic protected by applicable federal, state, or local laws. If you need assistance or a reasonable accommodation during the application process, please contact [e-mail].