Head of Cutaneous Leishmaniasis ProgrammeJoin to apply for the Head of Cutaneous Leishmaniasis Programme role at Drugs for Neglected Diseases initiative (DNDi)Head of Cutaneous Leishmaniasis Programme1 day ago Be among the first 25 applicantsJoin to apply for the Head of Cutaneous Leishmaniasis Programme role at Drugs for Neglected Diseases initiative (DNDi)Get AI-powered advice on this job and more exclusive features.The R&D organization drives 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 Head of Cutaneous Leishmaniasis (CL) clinical Programme plays a pivotal role in the strategic development of the disease programme and is responsible for the Clinical Development Plan (CDP). As the scientific leader, the incumbent overseas and coordinates study activities throughout the clinical stages, both globally and regionally. This position ensures regular alignment with the regional leadersSpecific Job ResponsibilitiesStrategic 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 OversightAccountability 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 budgetData 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 StrategiesWorks 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 ResponsibilitiesData 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 charterMedical Monitoring Ensures appropriate implementation for clinical trials within the programmme.Manage and supervise R&D projectsRegulatory consistency Ensures all product development activities align with the defined regulatory strategyTeam 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 appropriateCoordination with the Fundraising, Advocacy and Communication teamContributes toFundraising activities - providing support for developing grant proposals and report writingPresentations of the specific disease programme during advocacy meetings/activitiesEnhancing 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 organizationsProject Leader Responsibilities (if Directly Responsible For a Project)Accountability Be accountable for the project’s deliverablesResource Management Ensures efficient and cost-effective use of DNDi resourcesPresentations 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 requiredActs 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.The Head of Cutaneous Leishmaniasis reports to the NTD Leishmaniasis Mycetoma Cluster DirectorSecondary reporting line to the Office Director of the regionClose collaboration and coordination with the Cluster Director, Head of Visceral leishmaniasis and other members of the Leishmaniasis and Mycetoma Diseases Cluster. Collaborates with other members of the core initiative team, R&D transversal team members, Regional Office clinical staffParticipates in monthly core team meeting; contributing to discussions and decision making on the Initiative portfolioEngages with other members of the core initiative team, R&D transversal team members, and Regional Office teamsCollaborates with the pre-clinical and translational units on the development of the NCEs.Acts as a credible voice of the organization in the program area; identifying opportunities to represent DNDi and positioning the programme as a leader in the field. Develops and maintains partnerships and networksExperienceMinimum 12 years of proven record of leadership in clinical research and pharmaceutical product development and registrationProven ability to work effectively in a team environment and matrix structureExperience in building and leading teamsInternational Experience is desirableEducationA Medical Degree is desirable.Master degree or Ph.D. in relevant fieldFormal training or certification as required by the functionSkills and AttributesInitiative and Prioritization Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlinesSystematic thinking Clear and systematic thinking that demonstrates strong judgment and problem solving competenciesCommunication skills Excellent communication skills in multicultural, multilingual environments; including exceptional public speaking abilities to convincingly represent DNDi at high level eventsTeam Management / Leadership Experienced in leading global, multicultural teams with a strong track record in team motivation, project and budget management, and stakeholder engagement. Focused on driving high performance through inclusive and collaborative leadership.Strategic thinking Very strong strategic thinking and leadership abilities, including excellent management, negotiation, and advocacy skillsIndependence High ability to exercise a high degree of independence to ensure program delivery and explore new areas of activitiesR& D Technical SkillsExcellent knowledge of Clinical Research/DevelopmentStrong knowledge of Drug Discovery/DevelopmentStrong knowledge of Leishmaniasis, with emphasis in CL and its Clinical Research and Development needsStrong knowledge of Regulatory standards (GCP, GCLP and GMP)Excellent technical writing skills for procedures, protocols, manuscripts and reportsFluency in EnglishProficiency in Portuguese and SpanishWillingness and ability to travel globallyExcellent knowledge of Microsoft SuiteDNDi 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.Seniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionConsulting, Information Technology, and SalesIndustriesResearch ServicesReferrals increase your chances of interviewing at Drugs for Neglected Diseases initiative (DNDi) by 2xSign in to set job alerts for “Program Head” roles.FBA FC Operations Program Manager, FBA - Fullfillment by AmazonTechnical Program Manager (Senior/Lead) ID38557We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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