Director, Clinical Laboratory Operations

Job Title: Director, Clinical Laboratory Operations

Location: IAVI - Africa: Nairobi, Kenya, Cape Town, South Africa; OR Remote South Africa, considered

Reports to: Senior Director, Clinical Immunology and Lab Operations

IAVI is seeking a Director, Clinical Lab Operations to lead IAVI's lab operations in Africa. The Director will lead logistical, technical, and regulatory aspects of lab services for clinical trials, while driving lab quality, budget management, vendor oversight, often leveraging technology and data analysis optimizing performance. Director will lead strategy to support the development of vaccines and antibodies for HIV, TB, and emerging infectious diseases. Overseeing the implementation of good clinical lab practices (gCLP) across partner clinical research centers (CRCs) ensuring sustained and robust lab quality systems and operations.

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 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.

Organizational Overview:

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases.

IAVI CORE VALUES:

• Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
• Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
• Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
• Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference

Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an "at-will" relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

IAVI IS AN EQUAL OPPORTUNITY EMPLOYER actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues' experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI's Global Diversity and Inclusion Committee.

Compensation And Benefits Information:

Salary is paid in local currency, and is commensurate and competitive with the local labor market. Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits including: generous retirement savings plan employer contributions; competitive health, dental and vision insurance plans; competitive paid time off policy; potential for annual bonuses based on performance; and other benefits. More information can be found on IAVI's career page.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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