Job Purpose

The Business Operations Manager (US Region) is responsible for contributing to the overall health of the U.S. office through managing and improving internal operational functions. The role partners across Human Resources, Procurement, Finance and Accounting, and Clinical Operations, and oversees general administration.

This is a specialized position that combines a business operations foundation with working knowledge of the scientific and regulatory environment in which ARTIDIS operates. The person in this role is expected to apply specific knowledge of healthcare operations, medical device regulations, international business operations, clinical research environments, quality systems, and complex supply chain management - demonstrating a combination of business, regulatory, and technological acumen.

Working location: Artidis, Inc. - Houston office, located at 7255 Helix Park Ave, Suite 300, Houston, TX 77030.

Responsibilities:

Strategic Planning and Project Management

• Develop and implement strategic plans supporting the company's growth and operational efficiency, including setting goals, defining strategies, and monitoring progress.
• Oversee and manage various projects, ensuring they are completed on time, within scope, and within budget - including planning, executing, and closing projects.
• Efficiently allocate resources, including personnel, equipment, and budget, to meet the company's objectives.
• Work closely with departmental heads to ensure budgets are being met and that additional resources, when needed, are utilized in the most effective and efficient manner.

Clinical and Regulatory Operations

• Coordinate FDA-regulated investigational device operations.
• Support clinical studies and collaborations with institutions such as MD Anderson Cancer Center, Baylor College of Medicine, Fred Hutch Cancer Center, and Moffitt Cancer Center.
• Maintain FDA-compliant documentation and ensure compliance with Good Clinical Practice (GCP) requirements.
• Ensure proper compliance with all federal, state, and local regulations, including SOP compliance, CAPA-related processes, audit readiness, controlled documentation, and vendor qualification.
• Conduct onsite onboarding, credentialing, study logistics, and device deployment.

Supply Chain, Logistics, and Procurement

• Manage international logistics and import/export activities for medical devices and components.
• Oversee vendor qualification and procurement of specialized laboratory and medical equipment.
• Coordinate investigational device logistics, including device inventory reconciliation, coordination of device deployment to research institutions, and management of the controlled movement of investigational devices.

Cross-Functional Coordination and Administration

• Serve as the operational liaison between the U.S. organization and ARTIDIS headquarters in Switzerland.
• Partner with Human Resources, Procurement, Finance and Accounting, and Clinical Operations on shared operational processes.
• Oversee general administration of the U.S. office.

Qualifications:

• Master's degree in Business Administration.
• 6 months work experience in Business Management, Coordinator, or related position.
• Characterized by integrity, conscientiousness, discretion, and reliability.
• Strong ethical leadership abilities.
• Clear, concise written and oral communication skills.
• Excellent analytical skills; results-oriented and comfortable in a fast-changing environment.
• Strong and demonstrated use of Excel, Word, and PowerPoint.
• Thriving in a dynamic start-up environment, displaying a high level of flexibility, adaptability, and a "hands-on" mentality.
• Team player, with a pragmatic approach and creative problem-solving capabilities.

Working conditions:

The environment is a typical start-up with an intrinsically motivated international team. The company is an excellent place for rapid advancement and offers a promising opportunity to learn and share know-how in a very agile environment. The position requires the employee to go the extra mile when needed. We are looking for a team player who appreciates direct communication. The effort is rewarded with challenging tasks, the possibility to take responsibility, a highly driven team, and work serving a significant purpose. The position comes with a competitive salary and a bonus for outstanding performance.