3 Clinical Development jobs in South Africa

Position Description

Job Title: Medical Director, Clinical Development (1-year fixed term at 60% FTE)

Location: Cape Town South Africa Preferred; Remote South Africa, Nairobi Kenya considered

Reports to: Vice President, Head of Clinical Development

Are you an experienced Clinical Leader, who is eager to help translate science into global health solutions?

IAVI is seeking a Medical Director to serve as a leader within a clinical trial team. The Medical Director will help design clinical trial protocols as part of 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 serves as part of a team responsible for clinical studies for vaccines and monoclonal antibody candidates for prevention of emerging infectious diseases such as TB, HIV and emerging infectious disease (EID) candidates such as Lassa fever, Marburg virus disease and Ebola virus disease.

Key Responsibilities:

Clinical Trials and Observational Studies

• Ensure all clinical activities conducted are aligned with the overall program insofar the preparation and execution of assigned clinical research studies.
• Develop strategic and detailed implementation plans and procedures for assigned clinical research studies/trials.
• Provide oversight of clinical protocols, consent forms, data collection instruments, and preparation of suitable educational materials and regulatory documents for clinical research studies/trials.
• 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.
• Lead Protocol Teams for assigned clinical studies.
• Lead communication with the Principal Investigators and select external stakeholders, as deemed appropriate for assigned projects.
• Design analysis plans with attention to endpoint selection and measurements, adverse event management, and data collection, and conduct of the interim and final analysis meetings.
• Chair and manage the Protocol Safety Review Team (PSRT), prepare the PSRT Charter and participate in the review of blinded safety data for assigned projects.
• Coordinate the selection of Independent Data Monitoring Committee (IDMC) Members, and preparation of the IDMC Charter in partnership with and under leadership of Head of Clinical Development or delegate.
• Act as IDMC liaison, as directed by Head of Clinical Development or delegate.
• Act as medical monitor for the conduct of clinical trials with a focus on safety data monitoring, as will be instructed by Head of Clinical Development or delegate.
• Provide oversight of CRO partner medical monitoring for studies where medical monitoring is outsourced.
• Prepare interim and final reports in collaboration with the site investigators and other members of IAVI Clinical Development for clinical research studies/trials involved in.
• Collaborate with site investigators to collect, analyze, and report the data from studies in scientific meetings and publications as directed by Head of Clinical Development or delegate.

• Support activities and contribute to design Clinical Development Plans, in collaboration with other members of Clinical Development and clinical investigators, including late phase clinical trials, if candidates are successful.

• Participate in the development and implementation of training activities relevant to projects involved in.

Other duties

• Maintain in-depth medical/scientific knowledge about the assigned therapeutic area or product/ project involved in, including any unique properties involving both disease and products for which the incumbent is responsible.
• Perform other duties as assigned by the VP, Head of Clinical Development.

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 preferred.
• Understanding of ethics and regulatory landscape in Africa is required.
• 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.
• Diplomatic skills, excellent judgment, proven ability to present to all audiences ranging from high level scientific audiences to lay community groups.
• Strong organizational skills, resourceful, and mature self-starter, with proven experience in building a strong, coherent project and operations in resource poor settings with limited infrastructure.
• 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. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.

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.

Compensation And Benefits Information:

Salary is paid in local currency, and is commensurate and competitive with the local labor market. Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits including: generous retirement savings plan employer contributions; competitive health, dental and vision insurance plans; competitive paid time off policy; potential for annual bonuses based on performance; and other benefits. More information can be found on IAVI's career page.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Minimum Requirements

• Master's degree in science, immunology, medicine, microbiology, public health or associated allied health professions.
• Previous clinical trial conduct experience.
• Previous demonstrable project management experience.
• ICH (R3) and SA GCP certification.
• Computer literate and advanced skills with MS Office and MS Project.
• Previous eTMF or eISF software experience would be advantageous.

Personal Qualities and Competencies

• Strong attention to detail with a commitment to accuracy and data integrity.
• Excellent organizational and time management skills with the ability to manage multiple priorities under tight timelines.
• Effective communication and interpersonal skills to foster collaborative relationships across multidisciplinary teams.
• Ability to work proactively and independently, while also being a strong team player.
• Analytical and problem-solving skills with a practical, solutions-oriented approach.
• High level of integrity, discretion, and professionalism in handling confidential information.
• Adaptability and resilience in a fast-paced, dynamic early-phase research environment.

Key Responsibilities

• Co-ordinate the activities of the VM-CTU in accordance with the unit milestones and timelines.
• Convene routine meetings on behalf of the VM-CTU PI with funders, collaborators, sponsors (where applicable), site clinical trial teams and trial monitors. Including compiling and distribution of meeting summaries and tracking of action items.
• Provide JSC, PSRT, DSMB secretariat support (advance meeting scheduling and meeting summary coordination and distribution).
• Coordinate with the mucosal immunology laboratory, head of laboratory trial statisticians and data management to ensure the secure storage and curation of laboratory and basic science data that are batch processed from local and international laboratories.
• Report writing in accordance with funder requirements.
• Science presentation and medical writing support to the Principal Investigator.

Job Types: Full-time, Permanent

Work Location: In person