Dengue Programme Leader

The Research and Development Department includes three clusters of disease expert teams: NTD: Mycetoma and Leishmaniasis; NTD: Chagas, Filarial, and HAT; and Viral Diseases. These teams drive therapeutic innovation from the lab bench to the patient bedside, advancing DNDi’s portfolio of treatment candidates from the outset (with the design of target product profiles) to the end point (enabling patients’ access to new treatments).

DNDi established its South-Asia office in New Delhi in 2004. DNDi South Asia mobilizes and supports research and science institutions in the region to develop end-to-end approaches to conducting neglected disease R&D. It aims to co-create sustainable solutions with partners, share expertise with the regional biotechnology industry, and ensure access for patients. DNDi South Asia supports R&D projects for Visceral Leishmaniasis, Hepatitis C, Filariasis, Paediatric HIV, and Dengue. 

The Dengue program was initiated in 2022 and DNDi is partnering with dengue-endemic countries to find a safe, affordable, and effective treatment for dengue. Through these global collaborations, the activities will encompass joint projects to advance the pre-clinical development of new drug candidates and conduct clinical trials to test the most promising ones.

The Dengue Programme Leader plays a pivotal role in driving the scientific and strategic development of the programme. The incumbent supports the Head of Dengue Global Programme in overseeing preclinical and clinical activities at both global and regional levels, ensuring alignment with DNDi’s R&D strategy and effective collaboration across internal functions and external partners.

Play a key role in supporting the Head of Dengue Global Programme on the development and implementation of dengue disease strategy amongst the stakeholders involved in Dengue clinical research and health policy:

• Work with the Head of Dengue Global Programme, to deliver the key initiatives within the disease portfolio.
• Support and facilitate the disease strategy development with Dengue Alliance and other relevant stakeholders for early engagement and consultation.
• Support the development and execution of the approved project plans, identification of critical success factors and indicators for project evaluation.
• Alignment with Dengue Alliance Coordination on setting the agenda and progress of working groups, in line with the Dengue disease strategy
•  Responsibility for the program ’s deliverables, in consultation with Head of Dengue Global Programme
• Coordinate with functional leadership on project activities
• Supports efficient and cost-effective use of DNDi resources
• Participate in regular project reviews and team (core and extended) meetings, with other DNDi members as appropriate
• Support the development of a good communication strategy with the Ministry of Health of endemic countries, WHO representatives, and other important stakeholders
• Support the best use and performance of Dengue Viral disease advocacy platforms.
• Support the Head of Dengue Clinical Programme in delivery of objectives of the overall dengue clinical programme
• Collaborates with the pre-clinical and translational teams on the development and implementation of  disease strategy  on novel antivirals as needed.
• Support the monitoring of trial budget in the programme.

Project Leader Responsibilities (If directly responsible for a Project)

• Support the monitoring of trial budget in the programme. 
• Oversee the execution of the approved project plans, identification of critical success factors and indicators for project evaluation.
• Are accountable for the project’s deliverables
• Lead the project team
• Coordinate with functional leadership on project activities.
• Support the clinical operation team members allocated to project (clinical lead and CPM’s) to ensure that the investigators implement rigorous and quality clinical studies that meet ICH standards
• Ensures efficient and cost-effective use of DNDi resources
• Organize regular project reviews and team (core and extended) meetings, inviting other DNDi members as appropriate
• Produce and coordinate materials and for the SAC and DAC project reviews
• Review the progress reports at interim and formal management reviews presentations
• Advise on appropriate external experts to enhance the review process as required

Trial Documentation and Essential Document responsibilities

• Supports the Head of Dengue Clinical Programme in development of full clinical development plans (CDP), Investigator Brochures, Clinical Trial Concept Sheet/Protocol Synopsis/Protocol/Amendments, ICFs, Statistical Analysis Plan, Clinical Study Reports and any subsequent updates for trials within the Dengue Disease Area and Projects.
• Provide the high-quality review and interpretation of trial outcomes for assigned studies and oversee the presentation thereof in clinical study reports, and related study documentation to varied team and audiences.
• Supports the Head of Dengue Clinical Programme in the CSR development, with particular focus on the interpretation of efficacy and safety; and validation before it is shared with the Cluster Director and Medical Director.

   Trial Management

• Supports the Head of Dengue Clinical Programme in the definition of the study specified requirements for conducting a specified clinical trial (adapting the feasibility report).
• Validates the site selection assessment performed by the clinical operations’ team , and gives final approval for the study sites to participate in a specific project.
• Has overall responsibility of oversight of clinical data management activities associated with the conduct of clinical trials pertaining to the programme, except for DNDi trials in early phases with healthy volunteer subjects, which is under responsibility of the Head of Translational Sciences.

Acts as Medical Responsible for specific projects within the dengue programme, as delegated by the Head of Dengue Clinical Programme

• 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.
• 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.
• Is 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.

DSMB (Data and Safety Monitoring Board):

• Validates the DSMB composition and documentation related to the DSMB in consultation with Head of Clinical Programme, in partnership with the Medical Director/DSC and Cluster Director.
  •    Reviews and validates any major recommendation made by the DSMB (such as stopping a treatment arm or a study) and makes recommendations to SIRC.
  •    Attends open session of DSMB meeting, as described and agreed by all parties in the DSMB charter

Fundraising and Advocacy and Communication

•  Support the Head of Clinical Program in coordinating with the ad hoc units the fundraising activities by providing support for developing grant proposals and report writing

The above list of responsibilities is not exhaustive, and you may be required to undertake other responsibilities appropriate to your grade. 

Reporting line
•    Leader, Dengue Global Programme reports to Head of Dengue Global Programme

Interactions
•    Works with other members of the dengue and viral cluster team, R&D transversal team members (in particular, Clinical Operations and Integrated Clinical Development Sciences and Pharmaceutical Development), Regional Office teams
•    At the project/program or team level, external engagement focuses on day-to-day, operational interactions with stakeholders that directly affect program/project/team outcomes. Engagement is highly localized and specific to individual projects or teams. Participate to the cluster R&D quarterly review, cluster leadership monthly meeting, core team meeting and contribute to discussion and decision making on the Cluster portfolio

•    Medical Degree
•    At least 12 years of progressively responsible experience in a related field.
•    Management training is necessary.
•    Proven ability to work effectively in a team environment and matrix structure.
•    Experience working in the public and private sector is highly desirable
•    Proven track record in clinical research in acute febrile illnesses

•    Expertise in managing high-impact functions or complex programs.
•    Strong leadership in program development and delivery, impacting regions or teams.         
•    Ability to advise senior leaders on specialized topics.
•    Effective communication and representation at senior levels.

•    Excellent knowledge of Dengue and other acute viral illness.

•    Knowledge of Drug Discovery/Development
•    Excellent knowledge of Clinical Research/Development
•    Knowledge of Regulatory (GCP, GLP and GMP)
•    Excellent Technical writing skills (procedures, protocols and reports)

• Fluency in English
• Proficiency in local languages desirable
• Very good knowledge of Microsoft Suite

DNDi is committed to building a diverse, equitable and truly inclusive organisation. Our success and global reach are dependent upon our ability to encourage diversity and draw on the skills, understanding and experience of all our people. We particularly welcome applications from those who are underrepresented in at DNDi and across the sector, especially women, and including, but not limited to, black and minority ethnic candidates, and those with other protected characteristic.