HEAD OF CUTANEOUS LEISHMANIASIS PROGRAMME

Location: Latin America Region

The Drugs for Neglected Diseasesinitiative (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

Counting Brazil’s Fiocruz as a founding member and numerous collaborations with science and access leaders in Latin American region, DNDi established itself in Rio de Janeiro in 2004. An integral part of DNDi’s global network, DNDi Latin America nurtures R&D and access partnerships in the broad region eco-systems, including for Chagas disease, leishmaniasis, hepatitis C and dengue, while contributing to DNDi’s global strategy. It also undertakes advocacy in support of neglected patients and leads capacity-building projects through multi-country clinical research and drug discovery platforms, including the Chagas Clinical Research Platform and RedeLEISH and the Lead Optimization Latin America (LOLA).

The R&D organisation 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.

Purpose of the position

The Head of Cutaneous Leishmaniasis clinical Programme is a leading key role in the disease strategic development programme and is accountable for the Clinical Development Plan (CDP). The incumbent is the scientific leader of the program and manage the coordination and oversight of the study activities throughout the clinical stages, developed at global level and in the regions. They assure regular alignment with the regional leaders.

Specific Job Responsibilities

Play a key role in defining the disease strategy amongst the stakeholders involved in the CL clinical research and health policy:

• Oversee the cutaneous leishmaniasis clinical program.
• Contributes to the Leishmaniasis (VL and CL) product development strategy.
• Identify with support, Clinical Trial managers and the Regional Offices, the pre-clinical team and other DNDi units, and in consultation with the Cluster director, the key initiatives that constitute a solid CL disease strategy. To contribute to a good communication with the Ministry of Health of endemic countries, WHO representatives, and other important stakeholders
• Support the best use and performance of Cutaneous Leishmaniasis disease advocacy platforms.
• Promote collaboration and leadership across the different organizations involved in Cutaneous Leishmaniasis disease management.

Oversee the Cutaneous Leishmaniasis Programme and Project Management

• The Head of Cutaneous Leishmaniasis Programme is accountable for the overall clinical programme. This includes being accountable for the organization, the management of all trials sponsored by DNDi as part of the programme, and compliance with overall local, regional, and international regulatory obligations associated with the study/ies conducted, with the support of the CTM, local/regional clinical teams/monitors and CROs/consultants. Some or all the tasks linked to the programme trial management can be delegated to the CTM.
• Supervises the development of the Clinical Trial Protocol Synopsis, the Clinical Trial Protocols, and any Clinical Trial Protocol Amendment(s),
• ls responsible for the whole trial budget in the programme,
• Has overall responsibility of oversight of clinical data management activities associated with the conduct of clinical trials in Cl patients pertaining to the programme.
• Submits the Clinical Trial Protocol Synopsis to the SAC, (after the Medical Director has revised the document and given greenlight to the HDCP to submit the synopsis to the SAC)
• Oversee the execution of the approved project plans, identification of critical success factors and indicators for project evaluation.
• Support the Clinical Trial Managers to ensure that the investigators implement rigorous and quality clinical studies that meet ICH standards.
• Collaborate with the pre-clinical and translational units on the development of the NCEs.

Product Portfolio Strategies

• Is close coordination with the Head of VL ensuring the proper project management of the product portfolio for the Leishmaniasis (VL and CL) programs by proposing and implementing a product management framework and tracking progress, supported by the R&D Coordination team.

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 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.

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.
• Possibly attends open session of DSMB meeting, as described and agreed by all parties in the DSMB charter
• Ensures that medical monitoring is appropriately implemented for clinical trials within their programmme.

Manage and supervise R&D projects

• Ensures consistency of all product development activities with the defined regulatory strategy
• Supervise/manage the Cutaneous Leishmaniasis clinical trial managers.
• Assess suitable project staff, collaborators, investigators, and projects
• Organize regular project reviews and team (core and extended) meetings, inviting other DNDi members as appropriate –
• Fundraising and 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
• 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

• The Head of Cutaneous Leishmaniasis reports to the NTD Leishmaniasis Mycetoma Cluster
• Secondary reporting line to the Regional Director of the region

Interactions

• Close collaboration with the Director of the Cluster and Head of CL and other members of the Leishmaniasis (VL and CL) and Mycetoma Diseases, works with other members of the core initiative team, R&D transversal team members, Regional Office clinical staff Works
• 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.
• This role acts as a credible voice of the organization for a program area, identify opportunities to represent DNDi and position the program to be recognized as leaders in the field. This role develops and maintains partnerships and networks

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 in a Senior role, in clinical research, experience in product development and registration is a must
• 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 and pharmaceutical product development
• International Experience is desirable

Education

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

Other Requirements

• Fluency in English
• Proficiency in Portuguese and Spanish is desirable.
• Willingness and ability to travel globally
• Excellent knowledge of Microsoft Suite

Other information

• Status: Full time – Permanent role

To apply

• Please submit your application using the online form
• Deadline for application: accepting applications until 24 june
• Only shortlisted candidates will be contacted
• Application submission for this position may close early if we have enough suitable applicants