Clinical Operations Leader US

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most.

We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happener’.

We are looking for a Clinical Operations Leader to oversee and manage external FSP Clinical Site Managers through outsourcing vendors, and drive stakeholder engagement in a complex matrix organization. In this role, you will play a pivotal role in ensuring the successful and seamless execution of clinical trials by fostering strong internal and external relationships, optimizing processes and achieving business goals.

Your role

• Leadership and Team Management
• Provide leadership and oversight to external FSP Clinical Site Managers via outsourcing vendors, ensuring alignment with organizational goals and compliance with quality standards.
• Mentor and support team members in their professional growth and technical development.
  
  

• Vendor and Outsourcing Management
• Act as the primary liaison for outsourcing vendors, ensuring alignment with clinical trial objectives and compliance with regulatory standards.
• Address vendor-related challenges and implement corrective actions as necessary working with the global site management team.
  
  

• Matrix Collaboration
• Serve as the critical link between the local US organization and the global functional team, balancing regional needs with global objectives.
• Collaborate with global counterparts to harmonize processes, share best practices, and implement company-wide initiatives.
• Act as a change agent to adapt global strategies to the local context while ensuring compliance and efficiency.
  
  

• Operational Excellence
• Oversee the planning, execution, and delivery of clinical trials, focusing on site activation, patient enrolment, and data quality in alignment with Global Clinical Operations.
• Ensure compliance with ICH-GCP, local regulations, and company policies across all clinical activities.
• Champion risk-based quality management and operational improvements to enhance efficiency and outcomes.
  

Who are you?

• Bachelor’s degree in life sciences, healthcare, or a related field. An advanced degree (e.g., Master’s, PharmD, or PhD) is preferred.
• 7-10 years of progressive experience in clinical operations, including direct site management and vendor oversight.
• Deep knowledge and understanding of cell therapy, preferably autologous CAR-T cell therapy.
• Demonstrated success managing teams and stakeholders in a matrix environment.
• Proven track record of leading clinical trials in local and global setting.
• Strong knowledge of ICH-GCP guidelines, local regulatory requirements, and international clinical trial regulations.
• Excellent interpersonal and communication skills to engage internal and external stakeholders effectively.
• Solid strategic thinking to balance short-term execution with long-term planning and alignment across local and global priorities.
• Ability to address challenges and implement solutions.
  
  

What’s in it for you?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

Base compensation for this position ranges from $129,375 to $215,625. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time.

In addition, this position is eligible for participation in Galapagos’ performance bonus plan. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.

Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.

We are Galapagos: together, we make it happen…!