[Closing date: July 31, 2017]
Established in 2003, the Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development (R&D) organization that develops new, improved, and affordable medicines for deadly neglected diseases that afflict millions of the world’s poorest people.
DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. 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 Africa was established in 2003 in Nairobi to ensure connection with our founding partner KEMRI and support clinical development programs. This DNDi regional office conducts R&D projects in the Eastern Africa region (esp. Kenya, Uganda, Sudan, Ethiopia, Tanzania), including clinical activities and data management for clinical trials for treatments for leishmaniasis, paediatric HIV, mycetoma and others. It also leads capacity strengthening initiatives through multi-country research platforms with the objective to ensure sustainable R&D capacities for DNDi projects. The team has grown to approx. 30 people today. As part of the global strategy, DNDi is further empowering its regional teams to ensure a coherent regional development across disease areas and activities, while reinforcing coherence among disease clusters.
In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research and Development Partnership (GARDP), a not-for-profit research and development initiative to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all. GARDP aims to have at least two projects that address urgent global health needs ready for implementation by the end of 2016, and two more by the end of 2017.
In this context of increasing activities and regionalization, DNDi has engaged a reorganization process which aims at effectively implementing the recently approved business plan, and has decided to create the new position of Regional Clinical Leader for Eastern Africa at the crossroads of our matrix organization.
Purpose of the position
With the increased portfolio of Diseases in the DNDi Africa Nairobi office, the volume and variety of trials carried out in the eastern Africa region has increased, resulting in the need for a senior scientific leader to coordinate these concurring activities and bring senior R&D expertise to ensure the efficiency and high quality of the clinical operations.
DNDi has created a new senior position to sit on the regional leadership team in their capacity of Regional Clinical Leader and work very closely with the Geneva Headquarters, where the Disease team leadership is located. The Regional Clinical Leader is accountable for leading and ensuring quality of science and clinical activities of the regional office. The Regional Clinical Leader will enhance regional office standards and SOPs, aligning them with global standards and SOPs, and will oversee the clinical operations team delivery by ensuring clinical development projects are well planned, appropriately resourced and executed in a timely fashion in collaboration with the disease area teams.
S/he will lead transversal R&D resources located in the region, coordinating the allocation of resources to several disease programs.
The Regional Clinical Leader is thus accountable, together with the Disease team senior managers, for clinical development and operations of the Nairobi office.
This position is part of the regional management team and works closely with the R&D department based in Geneva.
Specific job responsibilities
Clinical Operations Management
To oversee clinical trial related activities within the region by providing leadership to the clinical operations team in Nairobi for efficient and effective delivery of clinical studies, including:
- Provide advice and experience on clinical study design in collaboration with the Disease program teams.
- Lead effective clinical implementation in the region in line with team objectives defined in the yearly Action Plan
- Supervise new clinical sites identification
- Ensure qualified and trained resources are allocated to disease programs, and ensure effective use of pooled resources at the office level
- Leverage global expertise (medical affairs, QA/QC, translational research, CMC) to support study implementation
- Contribute to Pharmacovigilance activities
To guarantee clinical trials are conducted under good practices:
- Respect of the rights, safety and protection of the persons participating in the clinical trials
- Knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) Good Clinical Laboratory Practice (GCLP) and International Conference on Harmonization (ICH) guidelines
- Respect of the applicable regulations and recommendations, and of the Clinical Trial Protocols while respecting the national regulations and laws of the countries where the clinical trials are carried out
- Accuracy, veracity, completeness, consistency of information collected with the source data compliance with the objectives, the planning, the timelines and the clinical trial budget
To contribute to access-related activities, in close coordination with Disease programs and Regional director.
Data centre management
- Supervise the data center work and development, in terms of prioritization, accountability for results and set delivery Key Performance Indicators (KPIs)
- Supervise and mentor clinical managers and head of data center
- Coordinate the allocation of pooled resources for clinical trials development
- Develop and manage planning tools and performance indicators for the office for clinical operations and contribute to global reporting
- Accountable for Nairobi office R&D team training, knowledge and skills development
- Part of the regional management/leadership team
- Identify and construct R&D specific partnerships at regional level
- R&D representational role with local R&D networks
- Participation to LEAP platform activities
Contribution to global R&D work and planning
- Participate in R&D team global teleconferences
- Contribute to the preparation of the annual Action plan
- Contribute to DNDi R&D publications
- Attend R&D global events as required
Skills & 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, and public speaking skills, ability to convince and represent DNDi at high level events
- Knowledge of managing global multicultural teams
- Willingness to travel regularly in the region of eastern Africa and internationally
- Highly organized and structured
- High analytical skills
- 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
- ICH and GCP knowledge
- Medical affairs, QA/QC, PV
- An understanding of regulatory affairs (regional agencies, EMA Art. 58, FDA)
- Experience in data management for clinical trials
- Over 10 years in clinical project management
- At least 10 years’ experience in clinical research at least 4 of which are as Project Manager for clinical trials at a Contract Research Organization (CRO)/ biotech or pharmaceutical organizations
- Proven record in managing and maintaining effective leadership with the clinical trial managers, partners and stakeholders in Africa
- Experience with Phase II – IV clinical trials. Phase I clinical trials experience an added advantage
- Proven record of scientific publication in high impact journals
- MD mandatory
- Postgraduate training
- Fluency in English
- Proficiency in local languages desirable
- Excellent knowledge of Microsoft Suite
- Deadline for application: Accepting applications until July 31, 2017
- Only shortlisted candidates will be contacted.
- Location: Nairobi, Kenya
- Status: Full Time position
- Start date: 01.09.2017