[Closing date: 20 May 2016]
DNDi seeks to appoint an experienced clinical development professional to lead its Filarial disease clinical program.
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. S/he 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 oversee the use of DNDi resources for the Filarial disease projects. S/he will be responsible for managing FILARIAL DISEASES team (Clinical Managers, Medical Manager, Project Coordinator) in Geneva and functionally in Regional Offices.
S/he will report to the R&D Director.
Specific Responsibilities of the head FILARIAL DISEASES Clinical Program
Develop the filarial diseases strategy and program
- Lead development and definition of the Filarial disease area strategy, sharing responsibility for the development of the DNDi FILARIAL DISEASES portfolio with the preclinical counterpart 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 critical 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 the stakeholders involved in FILARIAL DISEASE 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 DISEASE 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 Medical 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) project reviews in collaboration with the medical Director and R&D Director with especial emphasis on the disease area strategy
- To present progress reports at interim and formal management reviews
- To prepare and present budget plans for the responsible projects
- To advise on appropriate external experts to enhance the review process as required
Fundraising and 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 publication 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 that are related to, and have an impact on the DNDi therapeutic areas
- To actively participate in and contribute to knowledge and experience sharing with the other members of the DNDi R&D team
The position is based at DNDi’s HQ in Geneva – and will entail a significant amount of international travel.
The successful candidate should possess the following qualifications, experience and attribute:
- High level scientific qualifications – M.D in one or more of the relevant disciplines
- One of the two requirements must be met: Familiar with pharmaceutical regulatory requirements, documentation and processes for major international agencies (FDA, EMA etc.)
- Experience in conducting clinical research in endemic countries is highly preferred. 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, with interest in infectious and filarial diseases and in improving health in the developing world
- Credibility to represent DNDi at senior level to relevant medical experts, regulatory authorities, industry and academic partners and other stakeholders
- A track record of management and leadership skills
- Experience of international research collaborations, able to interact with internal and external collaborators of different cultures
- A dynamic leader who is also an excellent team player with an open collaborative working style.
- Energetic, self-motivated and resourceful, with the flexibility and hands-on approach to thrive in a fast-moving, virtual organisation
- Strongly supportive of DNDi’s vision/mission and sharing the organization’s values and philosophy
- High level of proficiency in written and spoken English language is required and proficiency in French.
Please send via email only a letter explaining why you are applying for this post and an up-to-date copy of your CV/resume to firstname.lastname@example.org.
Please indicate in the subject line of your email: Head of Filariasis Clinical Program
For the full position description and additional information about DNDi please visit our website at www.dndi.org
Accepting applications until 20th May 2016
Only shortlisted candidates will be contacted.