[Closing date: 20 October 2019]
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 (www.dndi.org).
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 eight 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. 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 programmes. 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 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
The Regional Clinical Operations Leader ensures standardization and implementation of clinical operations across projects and regions. The Regional Clinical Operations Leader will enhance regional office standards and SOPs, aligning them with global standards and SOPs, and will oversee the clinical teams delivery by ensuring clinical trials are well planned, appropriately resourced and executed in a timely fashion in collaboration with the disease area teams. S/he evaluates and monitors the work of clinical team members, allocates human resources to meet business needs and ensures that employees conform to policies and regulatory guidelines and conduct clinical activities in compliance with international required standards for documentation, patient safety, and data integrity. S/he identifies training needs and solves complex problems.
Specific job responsibilities
To oversee clinical trial related activities within the region by providing leadership to the clinical teams in Nairobi for efficient and effective delivery of clinical trials, including:
- Accountable for ensuring that DNDi’s a standardized framework for clinical operational activities is applied in the Regional Office and used by all team members involved in the design and conduct of assigned clinical trials
- Ensure Regional Office clinical teams are GCP complaint and implement all SOPs relevant to clinical activities
- Ensure tracking of all documents submitted to Health Authorities and Ethic Committees locally
- Maintain frequent and meaningful contact with clinical trial sites to assess performance issues and provide guidance as needed.
- Review and provide input to clinical operational plans including the study monitoring plan and other plans as needed
- Participate in the selection of investigational sites and support vendor selections
- Assist with protocol design
- Proactively identify project risks and resolves
- Oversee clinical trial sites’ adherence to pertinent regulations through review of monitoring reports, GCP audit report, communications with investigators, CPMs, and CRAs
- Lead ongoing review of data to ensure GCP
- Review the submission of trial-related and essential documents to the Trial Master File
- Identify and provide solutions to clinical trial issues and/or risks
- Represent clinical operations in cross-functional initiatives, as assigned by management, and may act on behalf of team when designated
- Provide or facilitate training to clinical study teams on assigned protocol specific topics
- Work closely with other teams in the organization, e.g. quality, regulatory, etc.
- Provide input into non-project related activities and development of department processes, procedures, and guidelines as requested
- Provide advice and experience on clinical study design in collaboration with the disease programme teams.
- Manage the pool of CRA’s, act as secondary supervisor to (Sr) CPM, (Sr) Medical Manager
- Contribute to access-related activities, in close coordination with disease programmes and regional director.
Data center management
- Supervise the data center work and development, in terms of prioritization, accountability for results and set delivery Key Performance Indicators (KPIs)
- Act as primary supervisor to the Senior Manager of the data center
- 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
Member of the 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
- Participate to the preparation of the annual budget, as well as their regular revisions
- Identify potentially risks impacting projects and/or DNDi activities as well discuss them to address and suggest mitigation strategies with the other MT members
- Participate in the monthly management team meetings in the region as well as ensure a fluid regional internal communication
- Participate in the Nairobi Cross Disease Task Force meeting as a member
DNDi works in a matrix setting with staff reporting into several superiors. This position is placed at the intersection for the disease teams and clinical operations, at the regional office level. S/he works closely with the clinical teams who directly report to the disease teams globally. Therefore, the main reporting lines, direct reports and interactions comprise:
- S/he reports primarily to the Medical Director regarding data centre operations and clinical operations
- S/he reports to Director, DNDi Africa Regional Office (ARO) for regional strategy, access, and interaction with partners
- S/he reports to Disease Area Leaders in regard to the objectives setting and coordinating the clinical operations work
- S/he oversees the disease (leishmaniasis, paediatric HIV, AMR) Senior Clinical Managers as regional (secondary) supervisor. Overall leadership of the disease programmes resides with the Disease Area Head based in Geneva and S/he is expected to oversee the work of the local teams in line with objectives agreed in the yearly Action Plan
- S/he supervises directly the Senior Manager of Data Centre in Nairobi
- S/he works in concert with the disease team leaders to set common goals for the East Africa-based disease teams and ensures that s/he is directing work of local tams towards those objectives.
- S/he also interacts with R&D transversal services (medical affairs, pharmaceutical development, translational, portfolio & project planning)
S/he has frequent interaction with DNDi staff and external stakeholders to coordinate provision of work or to advocate, persuade, and gain support or commitment. S/he represents DNDi for a programme/service area and develops and maintains relationship with current and future partners.
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, 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 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
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
- Clinical research, clinical trial practice and management, clinical data management degree, or equivalent degree is required
- Medical Doctor degree would be a plus
- Postgraduate level training and degree
- Project management degree and training
- Fluency in English
- Proficiency in local languages desirable
- Excellent knowledge of Microsoft Suite
- Status: full time – fixed term contract 3 years
- Deadline for application: Accepting applications until 20 October 2019
- Only shortlisted candidates will be contacted
- Application submission for this position may close early if we have enough suitable applicants