Medical Director, Clinical Development
IAVI
สถานที่ทำงาน
Nairobi
สถานะการจ้างงาน
เต็มเวลา
รายละเอียดงาน
Position Description:
Job Title: Medical Director, Clinical Development
Location: Nairobi, Kenya; Remote - Uganda; Remote - Nigeria; Cape Town, South Africa; OR Remote-South Africa
Reporting to: Senior Medical Director, Clinical Development (Africa)
Position Summary:
Are you an experienced Clinical Leader, who is eager to help translate science into global health solutions?
IAVI is seeking a Medical Director, Clinical Development to take a leadership role within a clinical trial team. The Medical Director will help design clinical trial protocols and 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 will be part of a team responsible for clinical development programs for vaccines and monoclonal antibody candidates for prevention of emerging infectious diseases such as Lassa fever, Marburg virus disease and Ebola virus disease, in addition to HIV and TB.
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.
• Willingness to travel up to approximately 35% of the time is required.
Organizational Overview:
IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV.
IAVI CORE VALUES:
• Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
• Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
• Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
• Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference
Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
IAVI IS AN EQUAL OPPORTUNITY EMPLOYER actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues’ experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI’s Global Diversity and Inclusion Committee.
IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide
