Director Operations

We are seeking a highly skilled and visionary Director of Operations to lead the development and operational strategy for our services portfolio, under which clinical trial consultancy, GMP/BSL3 small scale manufacturing as well as a new clinical facility, currently in the design  phase. This is a pivotal leadership role where you will be responsible for shaping and driving the operational foundation of the facility, ensuring that it is built to the highest clinical care  and GMP/BSLIII standards and operational efficiency. This role requires an individual with deep expertise in clinical and pharmaceutical manufacturing operations, excellent people and project management skills, and the ability to work collaboratively with internal and external stakeholders to bring the revenue and the facility to life.

Contact: info@infecta.org

We at INFECTA (infecta.org) strongly believe that early phase clinical trials can be designed to provide critical proof-of-concept data faster and more cost-efficient. Without compromising on quality, the INFECTA team takes pride in designing fit-for-purpose early phase clinical trials which aim to maximally derisk downstream clinical development.

We provide a wide range of services for the development of vaccines, therapeutics, antivirals and biologics. We use and develop various clinical research methodologies and are global leading experts on the controlled human infection models (CHIMs).

Emerging from the longstanding collaboration between five Dutch University Medical Centers and the Centre for Human Drug Research (CHDR), we have a strong legacy in early phase clinical research programs and a strong scientific orientation, including experience with CHIMs.

We are in the process of building our own dedicated CHIM clinical trial unit with 20 beds to open late 2027/early 2028

Key Responsibilities:

Pre-Opening Phase:

In this phase the Director of Operations will work closely together with the interim Chief Infrastructure Officer on the following:

• Strategic Planning & Facility Design: Collaborate with architects, contractors, and key stakeholders to ensure that the facility design aligns with operational needs and regulatory requirements. Provide input into the layout, equipment, and technology specifications to optimize clinical workflows.
• Project Management: Lead and coordinate the development and construction timeline, ensuring that milestones are met and that the facility is completed on time and within budget. Oversee all operational readiness tasks, including staffing, inventory, and technology implementation.
• Regulatory Compliance: Ensure the facility meets all local, state, and federal regulatory requirements. Work closely with legal and compliance teams to navigate the complexities of healthcare regulations, certifications, and accreditations.

The Director of Operations will be directly responsible for

• Staffing and Recruitment: Develop a staffing plan that supports the clinical and administrative needs of the facility. Oversee recruitment efforts for key leadership and operational staff. Ensure that the staffing model is scalable as the facility grows.
• Technology Integration: Lead the selection and integration of IT systems, management systems, and other technology infrastructure. Ensure systems are user-friendly and comply with healthcare data protection standards.
• Setup and lead:  finance department, HR department, IT and data management department, procurement department, initially with emphasis on purchasing equipment/fitout building
• Assist in setup of consultancy services

Key Qualifications:

• Education: Bachelor’s degree in Healthcare Administration, Business Administration or a related field. A Master’s degree (e.g., MBA) is highly preferred.
• Experience:
• Minimum of 7-10 years of progressive experience in (healthcare) operations, with at least 3-5 years in a leadership role (Director or higher).
• Proven track record of successfully managing the opening and operational launch of a healthcare facility including related services
• Proven track record of successful managing projects
• Experience with budget management, financial forecasting, and cost control.

Key Skills:

• Leadership & Team Management: Strong leadership and people management skills with the ability to lead diverse teams, build collaborative partnerships, and mentor staff.
• Project Management: Exceptional project management skills with the ability to handle multiple priorities, meet deadlines, and coordinate across various departments and external partners.
• Operational Excellence: Deep knowledge of healthcare operations, including staffing, patient flow, inventory management, and quality assurance
• Financial Acumen: Strong financial management skills, with the ability to create and manage budgets, track expenses, and make data-driven decisions to drive cost efficiencies without compromising quality of services.
• Problem-Solving & Decision-Making: Strong analytical and problem-solving skills with the ability to make critical decisions in high-pressure situations.
• Communication Skills: Excellent written and verbal communication skills. Ability to engage and influence both internal and external stakeholders effectively.
• Technology Savvy: Experience in managing healthcare IT systems (EHR, patient management software, etc.) and understanding of technology integration in clinical settings.

 
What we offer

• An exciting opportunity to be part of a start-up organization with a strong legacy in the life sciences academia and industry with a focus on innovation and client success.
• An environment where you can make an important impact in global access to pharmaceuticals and vaccines, with emphasis on LMIC and neglected diseases
• Competitive salary.
• A collaborative and growth-oriented work culture that offers both personal and professional development opportunities.
• Exposure to cutting-edge CHIM clinical trial services and technologies, including a GMP/BSL3 manufacturing facilities that are shaping the future of healthcare.

• Operational Efficiency: Develop and implement operational protocols, policies, and procedures to ensure seamless day-to-day operations. Focus on continuous improvement to reduce operational inefficiencies.
• Financial Management: Develop budgets, track expenses, and monitor key financial metrics. Ensure the facility operates within budget and achieves financial sustainability. Identify opportunities for cost savings while maintaining high standards of services.
• Staff Training & Development: Create and implement training programs for staff to ensure they are equipped with the knowledge and skills required to meet operational standards. Foster a positive and supportive workplace culture that promotes staff retention.
• Vendor Management: Oversee relationships with vendors and service providers, including medical equipment suppliers, facility maintenance teams, and IT contractors. Negotiate contracts and ensure service level agreements are met.
• Leadership & Team Collaboration: Lead cross-functional teams, fostering a collaborative environment to achieve operational and clinical goals. Work closely with clinical leadership to ensure alignment between operational objectives and patient care outcomes.

Education: Bachelor’s degree in Healthcare Administration, Business Administration or a related field. A Master’s degree (e.g., MBA) is highly preferred.

Experience: Minimum of 7-10 years of progressive experience in (healthcare) operations, with at least 3-5 years in a leadership role (Director or higher).

Proven track record of successfully managing the opening and operational launch of a healthcare facility including related services

Proven track record of successful managing projects

Experience with budget management, financial forecasting, and cost control.