Medical Director at International AIDS Vaccine Initiative (IAVI)

Key Responsibilities:

Clinical Trials and Observational Studies

• Ensure that all activities are integrated into an overall program for the preparation and execution of clinical research studies and clinical trials as well as preparation for eventual vaccine access and delivery.
• Develop strategic and detailed implementation plans and procedures for clinical research studies/trials. Provide oversight of clinical protocols, consent forms, data collection instruments, and preparation of suitable educational materials and regulatory documents.
• 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.
• As a member of Project Team, contribute to scientific assessments of novel IAVI candidate vaccines and provides the expert medical opinion and risk assessment that is required for prioritization and selection for further development.
• Lead selected Protocol Teams for clinical studies.
• Lead communication with the Principal Investigators and with the medical representatives of vaccine developers for assigned projects.
• Design analysis plans with attention to endpoint selection and measurements, adverse event management and data collection, selection of Data and Safety Monitoring Board (DSMB) Members, preparation of the Safety Monitoring Committee Charter and conduct of the interim and final analysis meetings.
• Monitor the conduct of clinical trials, including safety of data.
• Prepare interim and final reports in collaboration with the site investigators and other members of IAVI Clinical Development. Collaborate with site investigators to collect, analyze and report the data from studies in scientific meetings and publications.
• Design Clinical Development Plans, in collaboration with other members of Clinical Development and clinical investigators, including later phase clinical trials, if candidates are successful.
• Work with other members of the Clinical Development team and other IAVI colleagues to support strategic planning for portfolio expansion and clinical trials to evaluate novel products.
• Participate in the development and implementation of training activities with African and Indian clinical partners and supports publication activities in the region.

Other duties

• Develop work plans and budgets for clinical research studies, and monitoring/reporting achievement of work plan milestones.
• Represent IAVI with external agencies to develop collaborations or seek funding.
• Contribute to development of grant applications and reports for donors and granting agencies, in collaboration with the IAVI Development group.
• Contribute to development and reviewing of scientific and medical content of IAVI documents such as the IAVI Report and other IAVI educational materials.
• Represent IAVI in scientific, regulatory and other capacities.
• Maintain in-depth medical/scientific knowledge about the assigned therapeutic area or product, including any unique properties involving both disease and products for which the incumbent is responsible.
• Attend appropriate outside meetings and courses to maintain competency and awareness in assigned area, worldwide activities, and the vaccine community at large. Other national and international duties as assigned.

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:

• Proven 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.
• Proven experience leading and managing Medical and Clinical teams in clinical trial research is required.
• Proven ability to operate within a scientific, social, medical, or clinical research program is required.
• Understanding of ethics and regulatory landscape in Africa is required.
• Relevant experience working in developing countries, especially Africa region is required.
• Proven success in the development and implementation of site preparation activities for clinical trials, particularly in developing countries is required.
• Diplomatic skills, excellent judgment, proven ability to present programs to all audiences ranging from high level political to lay community groups are required.
• Strong organizational skills, resourceful, and mature self-starter, with proven experience in building a strong, coherent program and operations in resource poor settings with limited infrastructure are required.
• Ability to work in a decentralized system and maintain close working relationships with various departments at Headquarters and global locations is required.