Head of Dengue Global Programme

Worldwide with preference for Brazil, Malaysia, and India

CLOSING DATE: 22 Mar 2024

Share on twitter

Share on facebook

Share on linkedin

Share on email

Share on print

The Drugs for Neglected Diseases initiative (DNDi) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases affecting millions of the world’s poorest people. 

Together with more than 200 public research and industry allies worldwide, we use the power of partnership, innovation, open science, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people. Driven by collaboration, not competition, and by patients’ needs, not profits, we promote equitable access, foster inclusive and sustainable solutions, and advocate for a more effective global biomedical R&D system that meets the needs of neglected patients. 

13 new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, hepatitis C, and malaria that have saved millions of lives. We aim to deliver a total of 25 new treatments by 2028– addressing R&D gaps for neglected tropical diseases and viral infections, including new pandemic-prone diseases (such as COVID-19) and climate-sensitive diseases (such as dengue) with a focus on the needs of patients in low- and middle-income countries.

With more than 240 employees of 30+ nationalities located in nine offices on four continents, DNDi is committed to diversity, equity, and inclusion as essential parts of our culture and key drivers of our success. We encourage candidates of diverse profiles and backgrounds to apply. 

The R&D organization drive therapeutic innovation from the lab bench to the patient bedside. It develops DNDi’s portfolio of drug candidates from the onset (with the design of target product profiles) to the end point (enabling patients’ access to the new treatments). With members located in various DNDi offices worldwide, R&D teams are key enablers of DNDi’s virtual research model which relies on collaborative partnerships with industry and science partners worldwide, fully inclusive of LMICS clinicians and researchers. Projects are run by project leaders and team members regrouping needed expertise from all DNDi functions, beyond R&D.

The R&D organization include three clusters of Diseases expert teams: NTD/Mycetoma and Leishmaniasis, NTD/Chagas-Filarial-HAT and Viral Diseases. Medical Affairs (Pharmacovigilance, Clinical Quality and Assurance, Regulatory and Translational Sciences), Global Clinical Operations, Discovery and Pharmaceutical Development teams complement the R&D expertise. Projects review, Science and strategy is managed by the Scientific Internal Review Committee (SIRC); The R&D Coordination team lead the R&D organization for all other topics. 

Purpose of the position

The dengue programme is a new disease area to be initiated in 2022. The Head of Dengue Global Programme is a leading key role in the disease strategic development programme. The incumbent will be accountable for the Clinical Development Plan (CDP), managing coordination and oversight of all preclinical and clinical programme activities throughout all development stages, both at the global and regional levels and in collaboration with other R&D functions. The incumbent will also be responsible for implementation and coordination of dengue R&D partnership activities and ensure alignment of activities with regional offices.

Specific job responsibilities Tasks and Responsibilities

Play a key role in defining the dengue strategy amongst the stakeholders involved in dengue research and health policy

• Identifies with support from Advisors, Project Leaders, Clinical Project Managers, Access Project Manager, and the Regional Offices, the pre-clinical team and other DNDi units, and in consultation with the R&D Director and the Viral Disease Cluster Director, the key initiatives that constitute a comprehensive dengue strategy.
• Articulates the dengue strategy with stakeholders for early engagement and consultation.
• Contributes to communication strategy of the communications team with the Ministry of Health of endemic countries, WHO representatives, and other important stakeholders
• Supports the best use and performance of dengue advocacy platforms.
• Promotes collaboration and leadership across the different organizations involved in the dengue programme.
• Is accountable for implementation of dengue R&D partnership activities and providing appropriate scientific input & support for all activities related to clinical studies such as ensuring or delegating clinical documents writing, feasibility, medical review of data, medical information for the trial team, to medical managers and advisors/clinical Project Leaders, investigators and Key Opinion Leaders. Is responsible for ensuring trial participant safety management is implemented according to DNDi safety management system.
• They supervise/manage the (Sr) Project Leaders/Clinical Project Managers and they are the overall manager for the Dengue Team
• They manage the Project Leaders in charge of the R&D projects within their programme/dengue area

Oversee the Dengue Global Programme and project management

• They identify the key activities of the clinical and access projects. The Head of Dengue Global Programme is accountable for the overall programme implementation. This includes being accountable for the organization, the oversight of all trials sponsored by DNDi as part of their programme, and compliance with overall local, regional and international regulatory obligations associated with study conduct, with the support of the Clinical Project Manager (CPM), Medical Affairs department (pharmacovigilance, regulatory, quality assurance, etc) local/regional clinical teams/CRA’s and CROs/consultants. Most tasks linked to the programme trial operations can be delegated to the Clinical Project Manager (CPM) while the medical monitoring can be delegated to the Medical Manager (if existing).
• ls responsible for the respective budget programme while the project budget is delegated to the Project Leader and the trial budget is delegated to the CPM.
• They supervise/manage the dengue clinical and access project managers and other staff.

Trial documentation and essential document responsibilities

• Occupies a key role in developing or overseeing development (as appropriate and described in relevant SOPs) 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 Area and Projects along with the respective DNDi R&D teams.
• ls a mandatory member of the CDP Teams and reviews and validates the CDP prior to submission to the R&D Director and SIRC for final approval.
• Validates and submits relevant documents to Cluster Director, SIRC or Protocol Review Committee.
• Submits the Clinical Trial Protocol Synopsis to the Cluster Director for transmission to Scientific Advisory Committee
• 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.
• Is accountable for the Clinical Study Report development along with the relevant team, with particular focus on the interpretation of efficacy and safety; validate before it is shared with the Cluster Director and Medical Director.
• Supervises and review the Access Plan in whole their components.

Trial management

• Defines the study specified requirements for conducting a specified clinical trial (adapting the feasibility report) with the support of clinical operations team.
• Validates the site selection assessment performed by the CPM 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 (if applicable)

• 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 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.
• They are 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.

Fundraising, advocacy, and communication

• Coordinates with the ad hoc units the fundraising activities by providing support for developing grant proposals and report writing.
• Coordinates the presentations of the specific dengue programme during advocacy meetings/activities.
• Coordinates with DNDi reputation by scientific publications at various levels (originals, reviews, concept papers, etc), 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)

• 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 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 presentations for the SAC and DAC project reviews.
• Review the progress reports at interim and formal management reviews.
• Advise on appropriate external experts to enhance the review process as required.

Reporting line

• This position reports to the Cluster Director in the role of Head of Dengue Global Programme

Interactions

• Participate to the monthly core team meeting and contribute to discussion and decision making on the Initiative portfolio.
• Works with other members of the core initiative team, R&D transversal team members, Regional Office teams
• Collaborates with the pre-clinical and translational units on the development of the NCEs.
• In collaboration with the Viral Disease Cluster Director, she/he crafts the dengue strategy and turns it into operational reality through the design, development and implementation of programme/projects.

Job requirements Skills and attributes

• High ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
• Very clear and systematic thinking that demonstrates strong judgment and problem solving competencies
• Excellent communication skills in multicultural, multi-lingual environments
• Excellent communication, and public speaking skills, ability to convince and represent DNDi at high level events
• Knowledge of managing global multicultural teams
• Highly organized and structured
• High analytical skills
• High ability to lead large strategic projects.
• High ability to manage large size projects with budget management.
• Very strong strategic thinking and leadership abilities
• Excellent management, negotiation, and advocacy skills
• High ability to exercise high degree of independence to ensure program delivery and explore new areas of activities.
• High ability to interact with internal and external stakeholders.
• High ability to lead and motivate a team for optimum performance.

R&D technical skills

• Strong knowledge of Drug Discovery/Development
• Excellent knowledge of Clinical Research/Development
• Strong knowledge of Regulatory (GCP, GCLP and GMP)
• Excellent knowledge of Disease/academia knowledge
• Excellent technical writing skills (procedures, protocols, manuscripts and reports)

Experience

• Minimum 12 years’ relevant experience in a Senior role, in clinical research or equivalent
• Proven ability to work effectively in a team environment and matrix structure is critical.
• Experience building and leading teams.
• Proven track record in leadership in clinical research for dengue and/or other viral diseases

Education

• A Medical Degree is preferred.
• Master degree or Ph.D. in relevant field
• Formal training or certification as required by the function.

Other requirements

• Fluency in English
• Willingness and ability to travel globally.
• Excellent knowledge of Microsoft Suite

Other information

• Status: (Full time – Employee)
• Location: Worldwide with preference for DNDi Offices where we have Dengue Alliance partners (Brazil, Malaysia, or India)
• Deadline for application: accepting applications until 22 March 2024
• Only shortlisted candidates will be contacted.
• Application submission for this position may close early if we have enough suitable applicants.

Don’t miss our latest job opportunities. Stay in touch with news from our team

International non-profit developing safe, effective, and affordable treatments for the most neglected patients.

#J-18808-Ljbffr

---