Specific Job Responsibilities
- 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 (both Visceral leishmaniasis and Cutaneous leishmaniasis products.
- Initiatives Identification: Under the guidance of the Cluster Director, collaborates with Clinical Trial Managers (CTM), 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.
Strategic Leadership and Program Oversight
- 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..
Product Development Strategies
- Works closely with the Head of VL and Cluster Director to ensure effective project management of the product portfolio for the Leishmaniasis (VL and CL) program; this involves proposing and implementing a product management framework and tracking progress, with support from the R&D Coordination team.
Other Job Responsibilities
Data and Safety Monitoring Board (DSMB):
- Validate: Validates the DSMB composition and documentation in partnership with the Medical Director/ Drug Safety Committee.
- Review Recommendations: Reviews and validates major recommendations made by the DSMB (e.g,. stopping a treatment arm or a study) and makes recommendations to SIRC.
- Meeting Attendance: Possibly attend open session of DSMB meeting, as described and agreed upon in the DSMB charter
- Medical Monitoring: Ensures appropriate implementation for clinical trials within the programmme.
Manage and supervise R&D projects
- Regulatory consistency: 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
Contributes to:
- Fundraising activities - providing support for developing grant proposals and report writing
- Presentations of the specific disease programme during advocacy meetings/activities
- Enhancing DNDi reputation through scientific publications at various levels (e.g., originals, reviews, concept papers, etc), and taking a leading role in congresses.
- Coordinates major projects, platforms or initiatives involving various stakeholders or relevant organizations
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. Advises on appropriate external experts to enhance the review process as required
Acts as Medical Responsible ( optional)
- 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 for patient studies in the CL programme.
- Provides medical expertise to disease and cluster clinical teams, as needed.
- Maintains medical expertise in the therapeutic domain and maintains up to date Good Clinical Practice training.
- Responsible for and oversight of publications and publishing of results.
- Accountable for the production of the Medical Monitoring Plan for the trial, with support from the (Senior) Medical Manager, CPM, Pharmacovigilance function, data management and other functions as required.
- Is accountable for ensuring appropriate escalation of safety signals for drugs in their programme in accordance with DNDi pharmacovigilance SOPs.
- Interacts, as needed, with global regulatory authorities regarding the trial application, conduct, safety concerns and the presentation and interpretation of results, in partnership with the Medical Director.
