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.

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.

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.

 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.

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.

 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.

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.

 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.

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.