Reports to: Executive Medical Director
Position Summary:
The Medical Director, Clinical Development (CD) will lead a team responsible for the design, implementation, analysis and reporting of the clinical development program and clinical trials for specified candidate vaccines including HIV, TB and emerging infectious disease (EID) candidates. The Medical Director, CD may also assist in the design and implementation of epidemiological studies that will yield data required for design of efficacy trials appropriate to the populations for which vaccine candidates are designed, and/or which will yield specimens for research that may elucidate the natural history, pathogenesis and immune control of infection relevant for vaccine design. In addition, the Medical Director, CD will participate in the development and implementation of training activities with African and Indian clinical partners and will support publication activities in the region.
IAVI’s clinical research is conducted by cross-departmental teams responsible for individual clinical protocols and for each individual clinical trial site. The Medical Director is a key member of the IAVI Clinical Trials Team in the IAVI Clinical Development Department. He/she is primarily responsible for communication with the Principal Investigators and with the medical representatives of vaccine developers for assigned projects. He/she will 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.
The Medical Director works with the Project Teams and Protocol Teams, with general guidance of the Executive Medical Director and VP and Head of Clinical Development. He/she has a high degree of clinical and research competence and works with the Project Team under the general guidance of the Executive Medical Director and VP and Head of Clinical Development in selection and preclinical development of new candidates. He/she is responsible for protocol design and safety monitoring of clinical trials. He/she may, after consultation, represent IAVI with external agencies, to develop collaborations or seek funding. He/she is primarily responsible
Key Responsibilities:
Strategic planning for portfolio expansion and clinical trials to evaluate novel products.
Acts as internal consultant for clinical trials and epidemiological studies.
As a member of Project Teams, contributes 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.
Acts as a consultant to preclinical groups to contribute to the design of preclinical studies and their relationship to the overall clinical development plan, as appropriate
Leads selected Protocol Teams for clinical studies.
Designs Clinical Development Plans, leading to large-scale clinical research trials, in collaboration with other members of Clinical Development and clinical investigators, including Ph 2B and eventually Ph 3 trials, if candidates are successful.
Develops strategic and detailed implementation plans and procedures for clinical research studies/trials. Oversight of clinical protocols, consent forms, data collection instruments, and preparation of suitable educational materials and regulatory documents.
Designs 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.
Monitors the conduct of clinical trials, including safety data.
Prepares interim and final reports in collaboration with the site investigators and other members of IAVI Clinical Development. Collaborates with site investigators to collect, analyze and report the data from studies in scientific meetings and publications.
In concert with Clinical Operations colleagues develops work plans and budgets for clinical research studies, and monitoring/reporting achievement of work plan milestones.
Contributes to development of grant applications and reports for donors and granting agencies, in collaboration with the IAVI Development group.
Contributes to development and reviewing of scientific and medical content of IAVI documents such as the IAVI Report and other IAVI educational materials.
Represents IAVI in scientific, regulatory and other capacities, as needed.
Maintains 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.
Attends 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:
Passion for IAVI mission.
Medical degree and at least 10 years’ experience in clinical research. Board certification or equivalent in Medicine and/or Pediatrics and Infectious Diseases desirable.
Proven experience in preparing for and executing clinical trials or studies in international resource constrained settings. Knowledge of and experience with implementation of Good Clinical Practices (GCP) in clinical trials conduct a must.
Relevant experience working in developing countries, especially Africa region.
Proven success in the development and implementation of site preparation activities for clinical trials, particularly in developing countries.
Diplomatic skills, excellent judgment, proven ability to present programs to all audiences ranging from high level political to lay community groups.
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.
Experience in working in a decentralized system and maintaining close working relationship with various departments at Headquarters and global locations.
Proven ability to operate within a scientific, social, medical or clinical research program.
Willingness to travel at least 20% of the time.
