Head Clinical Operations USA, Director - Galapagos : Job Details

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, DirectorScope 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 roleClinical 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.

Who are you ?

• Advanced degree (MD, PhD, PharmD, or equivalent) in a health-related field or life sciences is preferable
• 8+ years of experience in clinical operations, including experience managing CROs and vendors.
• Proven leadership experience within the clinical research field, with the ability to manage both local and global stakeholders.
• Strong knowledge of ICH-GCP guidelines, local regulatory requirements, and international clinical trial regulations.
• Excellent communication, negotiation, and project management skills.
• Ability to navigate complex regulatory environments and resolve challenges efficiently.
• Experience in global initiatives and cross-cultural environments is a plus.

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. We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet. We are Galapagos : together we can make it happen...! 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. Base compensation for this position ranges from $142,450 to 264,550. 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 both Galapagos' performance bonus plan and long-term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.