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Leader of Disease Eradication Strategy
2 semanas atrás
The Head of Cutaneous Leishmaniasis Programme plays a pivotal role in the strategic development of the disease programme and is responsible for the Clinical Development Plan (CDP). As the scientific leader, the incumbent oversees and coordinates study activities throughout the clinical stages, both globally and regionally. This position ensures regular alignment with the regional leaders.
- Strategic Leadership: Plays a pivotal role in defining the disease strategy among stakeholders involved in CL clinical research and health policy.
- Program Oversight: Oversees the CL clinical program, ensuring rigorous scientific and operational standards.
- Product Development: Contributes to the strategic development of Leishmaniasis products.
- Initiatives Identification: Under the guidance of the Cluster Director, collaborates with Clinical Trial Managers, Regional Offices, the pre-clinical team, and other DNDi units to identify key initiatives that form a robust CL disease strategy. Facilitates effective communication with Ministries of Health in endemic countries, WHO representatives, and other critical stakeholders.
- Advocacy Platform Support: Enhances the utilization and performance of CL advocacy platforms.
- Collaboration and Leadership Engagement: Fosters collaboration and leadership across organizations involved in the management of CL.
Job Responsibilities:
- Accountability: The Head of the CL Programme is responsible for the overall clinical programme, including the organization and management of all trials sponsored by DNDi. This role ensures compliance with local, regional, and international regulatory obligations and is supported by Clinical Trial Managers, local/regional clinical teams/monitors and Contract Research Organizations/consultants. Some or all the tasks linked to the programme trial management can be delegated to the CTM.
- Protocol Development and Submission: Supervises the development of the Clinical Trial Protocol Synopsis, the Clinical Trial Protocols, and any Clinical Trial Protocol Amendment(s). Submits the Clinical Trial Protocol Synopsis to the Scientific Advisory Committee (SAC) after review and approval by the Protocol Review Committee.
- Budget Management: Oversees the programme's entire budget.
- Data Management Oversight: Maintains overall responsibility for clinical data management activities associated with trials involving CL patients.
- Project Execution: Oversees the execution of the approved project plans, identifying critical success factors and indicators for project evaluation.
- Quality Assurance: Supports the Clinical Trial Managers to ensure investigators conduct rigorous and high-quality clinical studies that meet ICH standards.
- Collaboration: Works with the pre-clinical and translational units on the development of the New Chemical Entities.
Other Job Responsibilities:
- Manage and supervise R&D projects: Ensures all product development activities align with the defined regulatory strategy.
- Team Supervision: Supervises and manages the CL Clinical Trial Managers.
- Staff Assessment: Evaluates and selects suitable project staff, collaborators, investigators, and projects.
- Project Review: Organizes regular project reviews and team (core and extended) meetings, inviting other DNDi members as appropriate.
Coordination with the Fundraising, Advocacy and Communication team:
- Fundraising activities: Provides support for developing grant proposals and report writing.
- Presentations of the specific disease programme during advocacy meetings/activities: Provides presentations on the CL programme at various advocacy meetings.
- Enhancing DNDi reputation through scientific publications: Develops and maintains partnerships and networks, enhancing DNDi's reputation through scientific publications at various levels.
Project Leader Responsibilities (if Directly Responsible For a Project):
- Accountability: Be accountable for the project's deliverables.
- Resource Management: Ensures efficient and cost-effective use of DNDi resources.
- Presentations and Report: Produces and coordinates materials and presentations for SAC and DAC project review and reviews progress reports at interim and formal management reviews.
Acts as Medical Responsible (optional):
- Medical Monitoring: Assumes or delegates the responsibility of the medical monitoring of trials to the (Sr) Medical manager and ensures directly or by oversight that medical monitoring is appropriately implemented for clinical trials within their programme.
- Co-chairs the protocol review committee: Co-chairs the protocol review committee for patient studies in the CL programme.
- Provides medical expertise: Provides medical expertise to disease and cluster clinical teams, as needed.
- Maintains medical expertise: Maintains medical expertise in the therapeutic domain and maintains up-to-date Good Clinical Practice training.
- Responsible for publications: Responsible for and oversight of publications and publishing of results.
