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 small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.
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 Head of Clinical Operations USA, Director
Scope of the job
The Head of Clinical Operations USA will lead and oversee all clinical trial activities within the United States and possibly in the North America and LATAM, ensuring high standards of execution and compliance with local and global regulatory requirements. This role involves managing relationships with outsourcing vendors and CROs (Contract Research Organizations) and its FSP model, acting as the primary liaison between the global and local organization, and contributing to both local and global strategic initiatives. The position requires a strong blend of leadership, operational expertise, vendor management, and cross-functional collaboration.
Your role
Clinical Operations Leadership:
- Oversee and manage all clinical trials within the country, ensuring alignment with global clinical development strategies.
- Ensure trials are conducted in accordance with applicable regulatory requirements, ICH-GCP guidelines, and company SOPs.
- Lead a team of clinical operations professionals, providing mentorship and development opportunities.
Vendor and CRO Management:
- Manage relationships with local CRO partners and their FSP models, vendors, and third-party partners involved in clinical trial execution locally ensuring alignment with the global outsourcing strategies.
- Ensure vendors deliver high-quality, timely, and cost-effective services that meet project and organizational goals.
- Establish key performance indicators (KPIs) and oversee vendor performance metrics, managing any issues or escalations as needed.
Stakeholder Management & Communication:
- Act as the primary point of contact between the global clinical operations team and the local organization.
- Liaise with local regulatory authorities and ensure the timely submission of clinical trial applications and reports.
- Collaborate with cross-functional teams including medical, regulatory, legal, and commercial departments, both at local and global levels.
Strategy & Initiative Involvement:
- Participate in global and local clinical operations initiatives, providing strategic input into the company’s clinical operations and development plans.
- Support the development and implementation of country-specific clinical strategies that align with global goals.
- Drive process improvement initiatives to enhance clinical trial execution efficiency and quality ensuring alignment with global clinical operations.
Compliance and Risk Management:
- Ensure all clinical trials comply with local regulatory and ethical requirements.
- Implement and maintain robust risk management strategies, identifying and mitigating operational risks related to clinical trial execution.
- Oversee quality assurance and audit processes for clinical trials.
Budget & Resource Management:
- Develop and manage the budget for clinical operations in the country, ensuring cost-effective use of resources, ensuring alignment with global clinical operations.
- Forecast resource needs and work closely with global teams to ensure appropriate staffing and funding levels.
