Rio de Janeiro, Brazil
[Closing date: 7 March 2016]
The Head of Chagas Clinical Program will play a leading role in strategic 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 and the DNDi R & D team and to directly oversee the use of DNDi resources for the Chagas projects. S/he will report to the R&D Director; and will be responsible for managing Chagas Clinical team in Rio and Latin America.
Specific responsibilities of the Head of Chagas Clinical Program
Develop Chagas clinical program
- To design disease strategy and update in coordination with DNDi regional and global leadership team
- To share the responsibility for the development of the DNDi Chagas disease portfolio with the preclinical counterpart. To collaborate with the Drug Discovery & Preclinical Research Team in developing Chagas disease strategy and ensuring the appropriate implementation
- To develop a full clinical development plan for new projects in the Chagas program, including NCEs
- To effectively execute approved project plans, to monitor milestone progression, to identify critical success factors, and key performance indicators for project evaluation
- To work with the Chagas clinical research and the investigators in resource-limited setting, to ensure the conduction of rigorous and quality clinical studies that meet ICH standards.
- To play a full role in the R&D team
Play a key coordination role amongst the key stakeholders involved in Chagas clinical research and policy makers
- To identify, with support from the Regional Office in Latin America, the key stakeholders for early engagement and consultation
- To ensure good communication with the national programs and WHO representatives
- To promote collaboration across the different organizations involved in Chagas management. To ensure a close and constructive relationship with the area of Preclinical and Discovery activities developed for Chagas
Ensure regulatory compliance for projects
- To be responsible for the quality and conduct of the clinical activities related to the current project plans together with Medical Director
- To ensure projects and investigators comply with best practice, follow regulatory pathway and keep appropriate documentation. together with Medical Director
- To drive and deliver an acceptable regulatory strategy for the adoption of the treatments in the endemic countries – in collaboration with project partners together with Medical Director
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 supervise/manage the project staff, currently including Clinical Manager and Project Coordinator
- To ensure efficient and cost-effective use of DNDi resources
- To interact with investigators on a regular basis to help them meeting milestones
- To organize regular internal project reviews together with the preclinical team and other DNDi members as appropriate (business development, communication …)
Enable review of projects
- To update the R&D and Medical Directors 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
- 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
The Head of Chagas will play a key role in the Chagas Platform.
- S/he will be the main interface with the Chagas Platform coordinator and will ensure that DNDi disease strategy is reflected on the Platform forum and translates into the research conducted by Platform investigators
- S/he will develop the Platform strategy and will animate the Chagas platform discussions and clinical research priorities
- S/he will work closely with the Chagas team in Rio and regional medical director to foster access-related discussions and assess priorities
- S/he will supervise the Chagas Plateform coordinator
ACCESS for Chagas Patients
Maintain a close support role to the regional medical director on issues related to Chagas access
- Fundraising and Advocacy and Communication
- To contribute to the fundraising activities by providing support to the fundraising proposal and report writing to secure success in funding our Chagas clinical activities
- To support the presentation of the Chagas 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 Chagas disease 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 Latin America Office in Rio de Janeiro – Brazil – and will entail a significant amount of international travels.
The successful candidate should possess the following qualifications, experience and attribute:
- High level scientific qualifications – M.D in relevant life science discipline
- One of the two requirements must be met:
- Experience in conducting clinical research in endemic countries highly preferred. Candidates with experience in infectious diseases in general, and knowledge on Chagas 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 diseases and in improving health in the developing world
- Familiar with regulatory requirements, documentation and processes for major international agencies (FDA, EMEA etc.)
- Credibility to represent DNDi at senior level to relevant medical experts, regulatory authorities, industry and academic partners and other stakeholders
- Proven 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 organization
- Strongly supportive of DNDi’s vision/mission and sharing the organization’s values and philosophy
- Proficiency for English, Spanish and Portuguese language required.
- Reports hierarchically to the R&D director
- Reports transversely to the Regional executive Head
- Part of the R&D leadership team
- Work closely with the Medical Director, Head of Translation, Head of Access and other Heads and clinical team members.
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.
For the full position description and additional information about DNDi please visit our website at www.dndi.org
Accepting applications until 7th of March 2016
Only shortlisted candidates will be contacted.