[Closing date: 31 May 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)
The DNDi Latin America office was opened in 2004. With the primary aim to support regional R&D activities for Chagas disease and leishmaniasis, the Latin American office also undertakes advocacy and communications activities to increase neglected diseases awareness in the region. It also leads capacity building projects through multi-country research platforms.
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 is 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
This position provides medical, public-health and scientific expertise and support for DNDi and GARDP projects in the Latin America region related to development of clinical activities and access to new treatments and medicines across targeted diseases areas and teams. This position also supports the establishment of relationships with regulatory authorities, healthcare providers, researchers, NGOs, public health officials and other key stakeholders in the region in order to implement the access projects identified. The Head Medical Affairs will work cross-functionally with the disease teams in the region and globally.
Specific job responsibilities
Regulatory Affairs and Medical Policy Affairs (25%)
- Work in partnership with disease areas and Global Head of Regulatory Affairs to develop regulatory plans and interactions with regulatory authorities
- Monitor and participates in the preparation, submission, and review of regulatory documentation in collaboration with disease team leaders
- Provide regulatory support to disease teams on clinical development plans and clinical trial requirement
- Participate in the review of clinical study protocols and critical non-clinical studies to ensure alignment with local regulatory requirements
- Develop knowledge on the regional regulatory environment and trends
- Bring a technical support to R&D teams in providing methodologies and sharing good practices in clinical trials
- At the regional level, ensure that all staff participating in clinical studies have the appropriate level of knowledge, skills, and experience, are fully trained in DNDi SOPs and GCP, and are constantly operating in a compliant manner
- Liaise with the Global Pharmacovigilance Leader and Latin America Pharmacovigilance Manager on pharmacovigilance strategy in all Latin America projects
- Work closely with the R&D team on ethical and regulatory issues capitalizing experiences and aiming on DNDi’s projects/trials optimization
- Transversally work with DNDi Regional disease platforms and catalyze articulation of their activities within the diseases’ regional strategies
Regional Scientific and Medical Reference (25%)
- As part of the regional leadership team, the Head of Medical Affairs participates to the regional strategy and in the preparation and implementation of the regional Action Plan under the guidance of the Regional Director
- Helps to develop/strengthen relationships with and raise the DNDi’s profile among policy makers, academia, science leaders, industry associations, media, community advocates, civil society and other influential organizations and key stakeholders in Latin America, maintaining close communication and interactions with all of them, as appropriate
- Work closely with R&D and Communications teams to respond media requests, gives interviews, provides scientific and technical inputs, and organizes events to educate and raise awareness about disease areas and innovations to address unmet medical needs. Attends congresses, scientific sessions and conferences in liaison with the R&D teams.
- Serve as a medical/scientific reference for the office and contributes to the understanding of emerging information on our products, disease states, ideas and trends in patient care.
- Gather medical evidence data around current projects to facilitate systematic analysis and refers them to the Dynamic Portfolio Lead in Geneva
- Provides research and analytical support to the Regional Executive Director; collaborates in preparation of advocacy and policy strategies as well as global positioning in the region (in alignment with global R&D disease strategies)
- Supports fundraising efforts in the region and globally by providing technical inputs and scientific rationale for proposals
- Guarantee a coherent approach to support and strengthen GARDP activities through intersectoral dialogue, political commitment and funding in Latin America Region
- Significantly contribute to the GARDP programme team to assess potential sites for future studies; continued support as required for GARDP studies in the Region
- Act as a senior medical contact for GARDP in Latin America Region
- Provide feedback to GARDP on the medical and scientific capabilities and resources of potential partners in the region
- Maintain relationships with and ensure continuous support of local partners
- Support GARDP NEO/Paeds programme teams to assess potential paediatric and neonatal sites for future studies; continued support as required for NeoOBs study
- Support site start-up activities (including communication around trial)
- Significantly contribute to the evaluation of progress of GARDP activities to ensure that projects will meet all critical success factors
- Liaise with GARDP programme team to continue building its registration and access plans in Brazil: including discussions with Anvisa, discussion with MoH around policy and use of a new drug, any additional studies that will be required in Brazil
- Facilitate regulatory approvals
- Lead the preparatory activities for interactions with regulatory authorities and lead or co-lead face to face meetings
- Manage and monitor preparation, submission, and review of regulatory documentation in collaboration with programme team leaders
- Play a critical role to support developing GARDP in its fundraising and communications efforts by providing technical inputs and scientific rationale for proposals, in coordination with GARDP project team and respective departments
- In collaboration with transversal areas, support the organization of Phase III/IV trial kick off meeting
- Guarantee a coherent approach in Argentina, Brazil, and Mexico through government intersectoral dialogue and political commitment and funding
- Support and strengthen GARDP activities according to their plans in the region, with a focus on obtaining funding for Zoliflodacin implementation studies n the key countries according to the Entasis license agreement (Argentina, Brazil, and Mexico)
- When requested and relevant, provide representation work for GARDP in the region (govt, international organizations, CSO)
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
- 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 programme delivery and explore new areas of activities
- High ability to interact with internal and external stakeholders
- High ability to manage budgets and teams
- High ability to lead and motivate a team for optimum performance
R&D technical skills
- Medical and business knowledge
- Advanced understanding of clinical development, knowledge and experience in international (FDA, EMEA, ICH) and local regulations is desirable
- Over 10 years in Senior role in the field of Public Health, Access, Global Health, and Medical Affairs
- Work experience in private or non-governmental organization setting with significant international exposure. Work experience in governmental or public institution is a plus.
- Proven ability to work effectively in a team environment and matrix structure
- Deep knowledge of Latin America countries in the context of global health
- Experience with a variety regulatory authority
- Medical Degree, advanced post graduate degree, or graduate degree with equivalent in experience to reach Master level
- Master’s in public health or science is highly desirable
- Fluency in English, Portuguese, and Spanish
- Excellent knowledge of Microsoft Suite
- The Head of Medical Affairs reports primarily to Regional Director
- S/he reports secondary to the Medical Director and is part of the Medical Affairs team with strong interaction with the Leaders in PV, Quality, and Regulatory
- The Head of Medical Affairs reports secondary to the GARDP Executive Director to ensure coherence on transactional activities for GARDP in the region.
- Interacts with Head of Diseases/Directors of Initiatives, as well as the Heads/Leaders of R&D transversal areas.
- The Head of Medical Affairs is responsible to supervise Access and Public Affairs Assistant and consultants
- Works with the Latin America regional team and with several teams and departments regionally and globally, including the GARDP team
- S/he has frequent interaction with DNDi and GARDP 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 develop and maintain relationship with current and future partners.
- S/he is part of the regional leadership team and global R&D team.
- Status: full time – permanent role – staff contract
- Deadline for application: Accepting applications until 31 May 2019
- Only shortlisted candidates will be contacted