Key Responsibilities:

Clinical Trials and Observational Studies

• 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.
• 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 and provides 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.
• Monitor the conduct of clinical trials, including safety of data.
• 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 later phase clinical trials, if candidates are successful.
• Work with other members of the Clinical Development team and other IAVI colleagues 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.
• Represent IAVI with external agencies to develop collaborations or seek funding.
• 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:

• Proven 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.
• Proven experience leading and managing Medical and Clinical teams in clinical trial research is required.
• Proven ability to operate within a scientific, social, medical, or clinical research program is required.
• Understanding of ethics and regulatory landscape in Africa is required.
• Relevant experience working in developing countries, especially Africa region is required.
• Proven success in the development and implementation of site preparation activities for clinical trials, particularly in developing countries is required.
• Diplomatic skills, excellent judgment, proven ability to present programs to all audiences ranging from high level political to lay community groups are required.
• 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 are required.
• Ability to work in a decentralized system and maintain close working relationships with various departments at Headquarters and global locations is required.

Key Responsibilities:

Data and Sample sharing Agreements:

• Ensure compliance with data and samples transfer systems, expediting negotiations and agreements to facilitate material and data sharing.
• In consultation with Legal/DCOP, review and approve agreements for both the transfer of outgoing and incoming material and data requests.
• Liaise with ADVANCE technical leads to ensure the intended use of materials and data is aligned with ADVANCE-specific research activities.

Sample Management:

• Coordinate with IAVI-HIL for the eventual sample inventory and transfer to the Africa based biorepository.
• Perform regular maintenance and updates to the ADVANCE team on sample management and storage.
• Working with the ADVANCE technical leads, ensure compliance with all sample and material transfer regulations in the respective jurisdiction

Data protection and Regulatory compliance:

• Assist in developing, implementing, maintaining, and monitoring privacy and data protection policies, processes, and controls at IAVI.
• Provide advice and guidance to the ADVANCE Project on all aspects of privacy and data protection in relation to relevant policies, procedures, processes, and initiatives, ensuring compliance.
• Conduct audits to ensure privacy and data protection compliance and proactively address potential privacy and data protection issues within the ADVANCE network.
• Take a lead role in assessing new legislation or other regulatory changes, making recommendations as necessary to ensure that risks are mitigated.
• Keep abreast of evolving privacy and data protection regulations, laws, and policies.
• Participate in and advise on security incidents, investigations, or privacy complaints and undertake reporting and remedial actions as necessary.
• Facilitate the preparation of data protection impact assessments for new products and services, ensuring due consideration is given to technical and organizational measures to protect and safeguard personal data.
• Support Legal and Procurement processes around privacy and data protection issues in contract negotiations and client relationships, highlighting to key stakeholders the necessity of adherence to customer data handling obligations.
• Oversee the delivery of privacy and data protection training and awareness for employees and IAVI CRCs involved in personal data processing, improving local/regional knowledge.
• Create and maintain documentation that provides evidence of legal and regulatory compliance.
• Foster a positive data protection culture within IAVI.
• Undertake any other reasonable and related tasks associated with this role as assigned by the manager

Education and Experience:

• Bachelors Degree in LawBusiness Administration, or a relevant degree is required.
• Minimum three years of experience working in data protection compliance or a related field is required.
• Privacy qualification(s) such as (CISMP, CISSP, CISA, CRISC, ISA, QSA, CIPP/E, CIPM, CIPT) is desirable.

Qualifications and Skills:

• Knowledge in EU, Uganda, Kenya, or South Africa data protection laws and practices is required.
• Strong project management skills is required.
• Ability to work well under pressure and manage sensitive and confidential information is required.
• Excellent verbal, written, and presentation skills, with strong attention to detail is required.
• Ability to work well both independently and as part of a team is required.
• Receptive to, and takes positive action on, feedback, recommendations, and requests is required.
• Clearly articulates viewpoints and respects others’ ideas is required.
• Excellent collaboration skills with internal and external stakeholders are required,
• Strives for excellence and seeks solutions to system/process failures, c
• Experience working with a clinical or scientific research organization is highly desirable
• Experience in standard regulatory environment such as research institutes is desirable.