[Closing date: March 26, 2017]
Established in 2003 Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for Neglected Diseases.
DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research and Development Partnership, a not-for-profit research and development organization to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all.
Since its inception, DNDi has developed seven new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, paediatric HIV with several new drug candidates in the R&D pipeline including two for sleeping sickness. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.
DNDi has a large portfolio of R&D activities covering 7 disease areas: human African trypanosomiasis, leishmaniasis, Chagas disease, filarial diseases, mycetoma, paediatric HIV and hepatitis C. R&D projects are driven by patients’ medical needs for each disease area that in turn set strategy and scientific approaches.
DNDi does not have any research facilities and does not directly conduct research to develop its treatments. DNDi follows a virtual research model, whereby most research is outsourced with the R&D projects actively managed by DNDi personnel who are experienced in different aspects of pharmaceutical development.
DNDi proactively identifies research opportunities that have the highest potential to be translated into improved treatment options, then sources the research project into its portfolio, builds the full development plan, identifies and contracts the appropriate partners for each step in the development process, and manages the efficient advancement of the project throughout the pipeline.
Over half of the R&D staff are located in Geneva working in close collaboration with disease-specific R&D teams operating in regional offices located in Africa, Asia and South America.
Purpose of the position
The Head of the Filarial Clinical Program will lead disease area strategy, development, program management, and regulatory oversight of multiple projects throughout all stages of the clinical development process for new treatments as well as for future new drugs that advance forward in the pipeline. He/she will be expected to maintain productive interactions with investigator teams, the DNDi R&D team, coordinating with research and translational efforts in the disease area and to directly the filarial diseases clinical staff in Geneva (one senior manager, two managers and one assistant) and functionally in regional offices where clinical operations will be ongoing.
Specific Job Responsibilities
Develop the filarial diseases strategy and program
- Lead development and definition of the filarial diseases area strategy, focusing in particular on onchocerciasis, and coordinate with R&D leadership on elaboration of the disease area strategy document.
- Define target product profiles for both mass drug administration and case management scenarios.
- Develop a full clinical development plan for new projects in the filarial diseases program, including NCEs and associated budgets.
- Effectively execute approved project plans, to monitor milestone progression, to identify success factors, and key performance indicators for project evaluation.
- To work with investigators in resource-limited settings, and conduct rigorous and high quality clinical studies that meet ICH standard and develop the filarial disease platform of clinical investigators.
- Define and implement the disease access strategy to enable patient access to therapy in collaboration with key stakeholders.
Play a full role in the R&D team as the filarial diseases expert and a key coordination role amongst stakeholders involved in filarial diseases in clinical research and health policy
- To identify, with support of the Regional Offices in India, Brazil and Africa, the key stakeholders for early engagement and consultation in DNDi activities in the field.
- To ensure good communication with the national programs and WHO representatives to promote collaboration across the different organizations involved in filarial diseases management.
Ensure regulatory compliance for projects
- To be responsible for the quality and conduct of the clinical activities related to the current project plans.
- To ensure projects and investigators observe best practice, follow regulatory compliance and keep appropriate documentation.
- To drive and deliver an acceptable regulatory strategy for the adoption of the treatments in the endemic countries in collaboration with project partners.
Manage and supervise R&D projects
- To assess and select suitable projects and investigators, and to recommend for management approval.
- To directly manage one or more R&D projects to lead project staff.
- To ensure smooth translation between research and development functions in execution of projects.
- To ensure efficient and cost-effective use of DNDi resources.
- To interact with investigators on a regular basis to help them meet milestones.
- To organize regular internal project reviews together with the preclinical team and other DNDi members as appropriate (e.g., business development, communication).
Enable review of projects
- To report to the R&D Director on progress of individual projects and budgets on a regular basis and present interim reviews.
- To prepare materials and presentation to the Scientific Advisory Committee (SAC).
- To present progress reports at interim and formal management reviews.
- To prepare and present budget plans for projects.
- To convene with appropriate external experts, review of projects/programs as required.
Fundraising, advocacy and communication
- To contribute to the fundraising activities by providing support to the fundraising proposal and report writing.
- To support the presentation of the filarial diseases program during advocacy meetings/activities.
- To produce timely scientific publications on project activities.
- To develop and update skills required for all aspects of project management.
- To maintain an awareness of all development activities in filarial diseases that are relevant to drug development and disease control.
- To keep an awareness of drug discovery and development in academia and in the biotechnology and pharmaceutical industry with impact on filarial diseases, in particular onchocerciasis.
- To actively participate in and contribute to knowledge and experience sharing with the other members of the DNDi R&D team.
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
- Familiar with pharmaceutical regulatory requirements, documentation and processes for major international agencies (FDA, EMA etc.).
- Minimum 12 years’ relevant experience in at least one of the two requirements: A) Experience in conducting clinical research in endemic countries is highly preferred. B) Candidates with experience in infectious diseases in general, and knowledge on filarial diseases in particular, will be given priority consideration.
- Extensive experience of designing and implementing clinical development programs gained in the pharmaceutical/biotech companies or CROs.
- Proven ability to work effectively in a team environment and matrix structure is critical.
- Experience building and leading teams in a start-up environment.
- Experience in resource mobilization and preparing proposals for donors.
- Master degree or Ph.D. in Life Science discipline.
- Fluency in English.
- Proficiency in local languages desirable.
- Willingness and ability to travel globally.
- Excellent knowledge of Microsoft Suite.
- Deadline for application: Accepting applications until March 26, 2017.
- Only shortlisted candidates will be contacted.