Key Responsibilities

Quality Assurance:

• Development, implementation and monitoring of quality systems for both the internal IAVI Laboratory Operations unit as well as those of site labs selected, including:
• Ensuring readiness for technical audits
• Ensure laboratory operations meet regulatory standards and sponsor requirements 
• Oversee preparation of sites for clinical trials and epidemiology studies.
• Oversee teams monitoring study progress at site laboratories for the duration of the study/trial.

Budget & Vendor Management:

• Development and management of operational budgets with budget managers and clinical teams based on study needs.
• Oversee the development of and implementation of associated integrated work plans and budgets, ensuring that the resources are allocated and deployed effectively.
• Review budgets and timelines ensuring integration with the overall clinical trials program.
• Identification and assessment of vendors to support Lab Operations.
• Development and review of scope of work, task orders and contracts for vendors.
• Management and oversight of procurement and vendor governance for a cost-effective and sustainable lab ecosystem. 

Team Leadership:

• Building and mentoring a high-performing team, fostering leadership development, and implementing succession planning. 
• Review and approval of all laboratory related documents for studies being implemented.

Technology & Data:

• Leading the adoption of digital systems like LIMS (Laboratory Information Management Systems) and other platforms for enhanced efficiency, data analysis, and performance monitoring. 

Regulatory Compliance:

• Ensuring all laboratory activities comply with Good Clinical Laboratory Practice (GCLP) and other accreditations (e.g. ISO 15189) and other relevant regulations and guidelines. 

Cross-Functional Collaboration:

• Serve in product development project teams as the laboratory lead.
• Serving as a key point of contact for CROs, clinical sites, and internal teams, influencing and leading clinical operations outcomes. 
• Representing IAVI and its partners in various areas such as presenting project progress, achievements, and lessons learned to donors, and other key stakeholders in meetings and conferences.

Education and Experience: 

• A Ph.D. in Immunology or related field and a minimum of 7 years of relevant independent research experience, either in a university or corporate setting, with experience working on clinical trials is required OR;
• A minimum of bachelor’s degree in life sciences or related field and 10 years’ experience in a safety laboratory will also be considered and clinical trials experience in developing countries is required.
• Experience working in a certified or accredited lab is required (e.g CLIA, ISO, CAP and GCLP).