Key Responsibilities:
Clinical Trials and Observational Studies
Ensure all clinical activities are integrated into an overall program for the preparation and execution of clinical research studies and trials.
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, providing 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.
Act as medical monitor for the conduct of clinical trials with a focus on safety data. For trials where medical monitoring is provided by a CRO, oversee the CRO’s medical monitoring.
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 late phase clinical trials, if candidates are successful.
Work with other members of the Clinical Development and cross-functional teams 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.
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:
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 required.
Understanding of ethics and regulatory landscape in Africa is required.
Relevant 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.
Ability to work in a decentralized system and maintain close working relationships with various departments at Headquarters and global locations is required.
Apply via :
recruiting.ultipro.com
