Medical Director
ID: 2014-1074
# of Openings: 1
Job Location: KE-Nairobi
Category: Research and Development
Overview:
The Organization - The International AIDS Vaccine Initiative (IAVI) is a nonprofit scientific and charitable organization founded in 1996 whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. IAVI will help advance the development of an AIDS vaccine by: 1) adding value to the HIV vaccine field by identifying opportunities and gaps in vaccine discovery and development where IAVI’s capabilities can best be leveraged; 2) partnering to advance quality HIV vaccine candidates to the clinic; and 3) ensuring that investments in HIV prevention and AIDS vaccine R&D remain central to the public policy and international health and development agendas by serving as a voice for the field in partnership with stakeholders and donors.
IAVI is a young, dynamic and mission-driven organization, and the work environment is fast-paced and intellectually stimulating, relying on the good cheer and high level of collaboration amongst its committed staff members.
Responsibilities:
Looking for a seasoned Medical Director to manage an exciting and expanding clinical trials and programs in Africa.
Job Title: Medical Director
Location: Nairobi/ Africa
Position Summary:
The Medical Director, Medical Affairs will lead a team responsible for the design, implementation, analysis and reporting of the clinical development program and clinical trials for specified candidate vaccines. The Medical Director, MA, will 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 HIV infection relevant for HIV vaccine design. In addition, the Medical Director, MA will participate in the development and implementation of
training activities with African clinical partners.
training activities with African clinical partners.
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 Medical Affairs Department. He/she is primarily responsible for communication with the Principle 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 Chief Medical Officer and matrix management from the Africa Regional Director. He/she has a high degree of clinical and research competence, and works with the Project Team under the general guidance of the CMO 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 for the clinical development of assigned candidates and/or clinical research studies.
Key Responsibilities:
- Strategic planning for portfolio expansion and clinical trials to evaluate novel products.
- Acts as internal consultant for clinical and epidemiologic studies
- Leads or participates in selected Protocol Teams for clinical and epidemiologic studies.
- Designs Clinical Development Plans leading to large-scale clinical research trials, in collaboration with other members of Medical Affairs and clinical investigators, including Ph 2B and eventually Ph 3 trials, if candidates are successful.
- With collaborating investigators, develops strategic and detailed implementation plans and procedures for clinical research studies/trials, in particular for expanded clinical research activities in Africa. Oversight of clinical protocols, consent forms, data collection instruments, and preparation of suitable educational materials and regulatory documents.
- Working closely with the Director, Clinical Laboratory, develop and implement degree and non-degree training activities with African clinical partners.
- Designs analysis plans with attention to endpoint selection and measurements, adverse event management and data collection, selection of Data and Safety Monitoring Board Members, preparation of the 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 Medical Affairs. Collaboration with site investigators to collect, analyze and report the data from studies in scientific meetings and publications.
- Participate in development of 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 External Relations group.
- Contributes to development of, and reviewing, 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, and epidemiology and natural history of HIV.
- Attends appropriate outside meetings and courses to maintain competency and awareness in assigned area, worldwide activities, and the HIV vaccine community at large. Other national and international duties as assigned.
Qualifications:
- Passion for IAVI mission
- Medical degree and/or Ph.D. in a medically related field, experience in clinical research. Board certification or equivalent in Medicine, Pediatrics, 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 HQ and IAVI and other designated laboratories.
- Proven ability to operate within a scientific, social, medical or clinical research program
- Willingness to travel at least 20% of the time.
To Apply:
