Director, Clinical Laboratory Operations at IAVI

• Are you an ambitious Clinical Laboratory Leader, eager to make an impact in a mission-driven organization?  IAVI is seeking a Director, Clinical Lab Operations to lead IAVI’s lab operations in East, West, and Southern Africa. The Director will lead logistical, technical, and regulatory aspects of lab services for clinical trials, ensuring compliant, efficient, and timely delivery of data for study success. The Director will ensure lab quality, budget management, vendor oversight, as well as the development of systems and SOPs, often leveraging technology and data analysis optimizing performance.  Serving as the chief representative for the clinical lab operation program in Africa, the Director will lead strategy to support the development of vaccines and antibodies for HIV, TB, and emerging infectious diseases. while overseeing the implementation of good clinical lab practices (gCLP) across partner clinical research centers (CRCs) and will ensure sustained and robust lab quality systems and operations.
• If you’re an experienced clinical lab leader, learn more and apply below! 

Key Responsibilities

Quality Assurance:

• Ensuring readiness for technical audits
• Ensure laboratory operations meet regulatory standards and sponsor requirements 
• Oversee preparatiDevelopment, implementation and monitoring of quality systems for both the internal IAVI Laboratory Operations unit as well as those of site labs selected, including:on 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).

Qualifications and Skills: 

• Experience managing clinical laboratory research projects and staff to deliver high quality data to meet project goals and deadlines is required.
• Broad knowledge of clinical medicine, pathology disciplines, basic medical sciences, clinical laboratory sciences, laboratory operations, and quality management systems required.
• Experience in safety labs analysis and assay validation and verification, as well as assay development and optimization is required.
• Experience and understanding of ICH GCP, GCLP and other relevant regulatory requirements for clinical trials.
• Knowledge of and skills in informatics, data analysis, and business management highly preferred.
• Experience with vaccine clinical trials and assay development is highly preferred.
• Understanding of and experience with implementation of Good Clinical laboratory Practices in infectious disease clinical trials conduct is required.
• Strong organizational skills with proven experience in building strong, coherent and efficient teams.
• Solid reasoning and analytical skills.
• Experience in working in a decentralized system, and maintaining close working relationships with various departments, contractors, clinical centers and clinical and basic science laboratories.
• Excellent verbal and written communication skills.
• Proven ability to present programs to audiences ranging from high level scientists, clinical investigators and physicians, clinical trials execution teams and non-scientists is highly desirable.
• Experience working in a multicultural environment is required.
• Willingness to travel at least 20-25% of the time to IAVI regional and head offices required.
• Passion for the IAVI Mission.