Latest Jobs at IAVI

• IAVI is seeking a Medical Director to serve as a leader within a clinical trial team. The Medical Director will help design clinical trial protocols as part of clinical development plans for products in development and will ensure clinical trial sites are executing studies with the highest standards of scientific integrity, safety, and ethics. The Medical Director serves as part of a team responsible for clinical studies for vaccines and monoclonal antibody candidates for prevention of emerging infectious diseases such as TB, HIV and emerging infectious disease (EID) candidates such as Lassa fever, Marburg virus disease and Ebola virus disease.

Key Responsibilities:

• Clinical Trials and Observational Studies
• Ensure all clinical activities conducted are aligned with the overall program insofar the preparation and execution of assigned clinical research studies.
• Develop strategic and detailed implementation plans and procedures for assigned clinical research studies/trials.
• Provide oversight of clinical protocols, consent forms, data collection instruments, and preparation of suitable educational materials and regulatory documents for clinical research studies/trials.
• Provide advice on clinical trials and epidemiological studies, particularly to the preclinical groups on the design of studies and their relationship to the overall clinical development plan, as appropriate.
• Yield data required for design of efficacy trials appropriate to the populations for which vaccine candidates are designed, and/or which yields specimens for research that may elucidate the natural history, pathogenesis, and immune control of infection relevant for vaccine design. 
• Lead Protocol Teams for assigned clinical studies.
• Lead communication with the Principal Investigators and select external stakeholders, as deemed appropriate for assigned projects.
• Design analysis plans with attention to endpoint selection and measurements, adverse event management, and data collection, and conduct of the interim and final analysis meetings.
• Chair and manage the Protocol Safety Review Team (PSRT), prepare the PSRT Charter and participate in the review of blinded safety data for assigned projects.
• Coordinate the selection of Independent Data Monitoring Committee (IDMC) Members, and preparation of the IDMC Charter in partnership with and under leadership of Head of Clinical Development or delegate.
• Act as IDMC liaison, as directed by Head of Clinical Development or delegate.
• Act as medical monitor for the conduct of clinical trials with a focus on safety data monitoring, as will be instructed by Head of Clinical Development or delegate.
• Provide oversight of CRO partner medical monitoring for studies where medical monitoring is outsourced.
• Prepare interim and final reports in collaboration with the site investigators and other members of IAVI Clinical Development for clinical research studies/trials involved in.
• Collaborate with site investigators to collect, analyze, and report the data from studies in scientific meetings and publications as directed by Head of Clinical Development or delegate.
• Support activities and contribute to design Clinical Development Plans, in collaboration with other members of Clinical Development and clinical investigators, including late phase clinical trials, if candidates are successful.
• Participate in the development and implementation of training activities relevant to projects involved in.

Other duties 

• Maintain in-depth medical/scientific knowledge about the assigned therapeutic area or product/ project involved in, including any unique properties involving both disease and products for which the incumbent is responsible.
• Perform other duties as assigned by the VP, Head of Clinical Development.

Education and Work Experience:

• A Medical degree is required.
• Minimum 6 years of experience in clinical research is required.
• Board certification or equivalent in Medicine, Pediatrics, Infectious Diseases, or pharmaceutical medicine is highly desired.

Qualifications and Skills:

• Experience in preparing for and executing clinical trials or studies in international resource constrained settings is required.
• Knowledge and experience with implementation of Good Clinical Practices (GCP) in clinical trials conduct is required.
• Experience leading and managing Medical and Clinical teams in clinical trial research is preferred.
• Understanding of ethics and regulatory landscape in Africa is required.
• Experience working in developing countries, especially Africa region is required.
• Experience developing and implementing site preparation activities for clinical trials, particularly in developing countries is required.
• Diplomatic skills, excellent judgment, proven ability to present to all audiences ranging from high level scientific audiences to lay community groups.
• Strong organizational skills, resourceful, and mature self-starter, with proven experience in building a strong, coherent project and operations in resource poor settings with limited infrastructure.
• Willingness to travel up to approximately 35% of the time is required.

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• 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.