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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 that affect 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.
Since our inception, DNDi has delivered nine new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, hepatitis C, and malaria that have saved millions of lives. We now aim to deliver an additional 15-18 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 250 employees of 37 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.
Purpose of the position
The Head of HIV Programme is a leading key role in the disease end-to-end strategic development and is accountable for the Clinical Development Plans (CDP). The incumbent is responsible for 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 and oversight over related HIV access plans. The incumbent will also be responsible for implementation and coordination of HIV R&D partnership activities and ensure alignment of activities with regional offices.
Specific job responsibilities
Play a key role in defining the disease strategy amongst the stakeholders involved in the HIV clinical research and health policy
- Identifies with support from Advisors, Project Leaders, Clinical Project Managers, Access Project Managers, and the Regional Offices leadership, the pre-clinical team and other DNDi units, and in consultation with the R&D director and the Cluster Director, the key initiatives that constitute a solid disease strategy
- Articulates the disease strategy with stakeholders for early engagement and consultation
- Contributes to good communication with the Ministries of Health WHO representatives, and other important stakeholders
- Supports the best use and performance of HIV advocacy platforms.
- Promotes collaboration and leadership across the different organizations involved in the disease programme
- Is Accountable for providing appropriate medical input & support for all activities related to clinical studies such as clinical documents writing, medical training, 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.
- Supervises/manages the (Sr) Project Leaders/Clinical Project Managers and is the overall manager for the Disease Team
- Manages the Project Leaders in charge of the R&D and Access projects within their programme/Disease area
Oversee the HIV programme and project management
- The Head of HIV Disease shall identify the key activities of the clinical and access projects and is accountable for the overall programme. This includes being accountable for the organization, the management 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 CPM while the medical monitoring can be delegated to the Medical Manager (if existing).
- ls responsible for the budget for the programme while the project budget is delegated to the Project Leader and the trial budget is delegated to the CPM
- Supervise/manage the HIV 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 yours Disease Area and Projects.
- ls a mandatory member of the CDP Teams and reviews and validates the CDP prior to submission to the cluster Director, R&D Director and SIRC for final approval
- Appoints the members of the Protocol Development Sub-Team (PDT)
- 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 the Scientific Advisory Committee (SAC).
- 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 (CSR) development, 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 all their components
- Defines the study specified requirements for conducting a specified clinical trial (adapting the feasibility report).
- 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.
- 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.
- 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.
- 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.
DSMB (Data and Safety Monitoring Board):
- Validates the DSMB composition and the documentation related to the DSMB in partnership with the Medical Director/DSC.
- 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, 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 disease 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
- 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
Nairobi-Regional Management team
- Is part of the regional management team, and takes part of the development of the regional strategy under the supervision of the regional executive director
- Is part of the preparation and implementation of the regional Action Plan.
- Participates to the preparation of the annual budget, as well as their regular revisions.
- Identifies risks potentially impacting projects and/or DNDi activities as well discuss them to address and suggest mitigation strategies with the other MT members.
- Participates in the monthly management team meetings in the Region as well as ensure a fluid regional internal communication
The above list of responsibilities is not exhaustive, and you may be required to undertake other responsibilities appropriate to your grade. This job description may be subject to review.
- This role reports to Head Viral Cluster Director with a dotted reporting line to the Regional Office Director
Skills and attributes
- Proven track record in leadership in delivery of HIV programmes with desirable experience in clinical research
- Very strong knowledge of Drug Discovery/Development
- Excellent knowledge of Clinical Research/Development
- Excellent knowledge of Disease/academia knowledge
- Excellent Technical writing skills (procedures, protocols, manuscripts and reports)
- 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 programme 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
- Over 8 years in Senior role
- Proven ability to work effectively in a team environment and matrix structure.
- Experience of working in public and private sector is highly desirable
- Medical Degree
- Master’s degree or Ph.D. in relevant field
- Travel up to 25%
- Please submit your application using the online form
- Deadline for application: Accepting applications until 19 June 2022
- Only shortlisted candidates will be contacted
- Application submission for this position may close early if we have enough suitable applicants