[Closing date: 19 July 2018]
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 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.
In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research & Development Partnership (GARDP), a not-for-profit research and development organization to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all. DNDi is responsible for GARDP’s incubation until it is established as an independent legal and operational entity (objective for early 2019). Going forward, a strong strategic alignment will be critical for the success of both organizations and this role will provide advice and expertise to GARDP as part of that alignment.
Medical Affairs department is a transversal function that is responsible for providing medical and clinical expertise to internal and external groups and provides significant input in designing, conducting and reporting clinical trials following GCP’s and other frameworks, for both DNDi and GARDP. Medical Affairs’ department covers Quality, Pharmacovigilance and Regulatory Affairs activities and is also responsible to enhances DNDi’s and GARDP’s scientific reputation and promotes the work of Research and Development (R&D) to inform about the proper use of the DNDi’s and GARDP products developed through collaboration with our partners.
Purpose of the position
The purpose of this role is to ensure the quality and compliance of DNDi clinical activities, to ensure that patient safety remains the highest priority for DNDi -, to ensure that cogent regulatory strategies are defined and agreed for all DNDi and to interact with regulators, WHO and other key stakeholders in matters of strategic importance. The Medical Director will oversee a team of almost 20 staff and consultants in Geneva and Regional Offices.
Specific job responsibilities
Patient Safety, reporting directly to the Executive Directors of DNDi
Accountable to the Executive Directors, responsible for patient safety risk, including ensuring that DNDi clinical safety reporting meets all requirements and expectations (ensuring safety risk management plans are in place appropriate to the development phase of the project, SAE reporting, pharmacovigilance for approved products (as appropriate), provision of annual and other safety reports, etc.). This also includes the management of any serious incidents associated with any DNDi clinical activity including the escalation and communication process and convening an appropriate senior management committee to oversee and manage the process. S/he will provide oversight of GARDP clinical safety reporting until it is established as an independent legal and operational entity. When this is in place the DNDi Medical Director role will serve as advisor and offer expert opinion to the GARDP Head of Clinical Affairs.
Regulatory Affairs, Quality, and Medical Policy Affairs, reporting to the R&D Director of DNDi
- Responsible to ensure that regulatory strategies for programmes are in place, reviews and approves regulatory plans
- Work in partnership with disease area leaders to develop regulatory plans
- Participate with Initiative/Programme Heads in interactions with regulatory authorities
- Ensure that all clinical studies are performed to GCP standards and meet the highest ethical standards
- 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 operating in a compliant manner at all times
- Ensure that all Contract Research Organizations engaged to perform clinical studies or related support activities on behalf of DNDi have the appropriate SOPs in place, are fully GCP compliant, and operate to the highest ethical standards
- Ensure that effective technical assurance mechanisms are in place and are operating efficiently to ensure all DNDi sponsored clinical study designs are capable of achieving the desired objectives and outcomes for the study. In this function, the Medical Director will be accountable for the sign-off of all DNDi clinical protocols (investigational and non-investigational).
- Ensure that all monitoring mechanisms are in place to ensure that clinical documentation, ethical, and regulatory submissions meet agreed quality criteria, and produce the Medical Monitoring Plan with the support of other functions as required
- Approves Monitoring Plan, if s/he is the medical responsible for the trial, performs the medical monitoring according to the medical review specification and defines the medical review specifications contained within the Medical Monitoring Plan
- Reviews and approves R&D Clinical QDs if delegated by the R&D Director
- Ensure that pharmacovigilance strategy is in place in all programmes
- Accountable for all clinical development activities including pharmacovigilance-related ones necessary for the conduct of clinical trials sponsored by DNDi. S/he is therefore, responsible for all investigational Medicinal Products (IMPs) safety profile monitoring, the continuous risk/benefit assessment related to the administration of IMPs to trial subjects, with the support of the DNDi PV Team.
- Ensure (jointly with the Executive Director), that an effective PV system is in place to assume responsibility and liability for the conduct of clinical trials in compliance with applicable statutory requirements and guidelines
- Review and approve/sign Development Safety Update Reports (DSUR), study-specific safety management plans (SMP), and investigators Brochures (lBs)
- Dev. of clinical SOP: the Medical Director (if s/he is the Medical responsible person) arbitrates in the event of non-agreement between process owner/author and process partner/reviewers
- Ensure together with the Initiative/Programme Directors/Heads (who are accountable) that Clinical Development Plans (CDPs) are in place in all programmes, reviews, and approves the clinical dev plans from medical perspective
- Accountable for internal reviews of clinical protocols as well as coordinating review by the Scientific Advisory Committees (SAC), the Medical Director ensures that each synopsis is submitted to SAC for their review and recommendations
- Contribute to shaping the Global Health R&D environment. Lead specific workstreams (or contribute as appropriate) and/or represent DNDi upon request of either R&D or Executive Director on discussions with key stakeholders on medical affair related issues (e.g.: WHO working groups, supranational bodies, regulatory authorities…)
- Advisory role to the GARDP Head of Clinical Affairs and support to the GARDP R&D Director where appropriate
Clinical development and data management
- Bring a technical support to clinical teams in providing methodologies in clinical development and sharing good practices in clinical trials.
- Oversee the data management strategy including support the DNDi Data Center in Nairobi with supervising the activities and bring a technical expertise to the local teams.
- This role has the important obligation to work on the DNDi SAC preparation and attend the DNDi Board meetings for SAC reporting
- The Medical Director will sit on the Internal Scientific Coherence Committee meetings and contribute to the discussion by providing updates on their areas of responsibility and contribute to the group discussion and decision making on a broader set of topics that are of strategic importance to the organization
- Representations responsibilities: the Medical Director plays a key role as spokesperson and represent DNDi in high level conferences, key R&D meetings, and major events. S/he will partner with organization such as WHO, Development Institute in Geneva, etc.
- Minimum 15 years’ relevant experience including several at senior management level
- Proven ability to work effectively in a team environment and matrix structure is critical
- Experience building and leading teams in a startup environment
- Proven track record in medical affairs
Skills and attributes
- Excellent 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 skills in multicultural, multi-lingual environments
- 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
- Excellent analytical skills
- Excellent ability to lead large strategic programmes
- Excellent ability to manage organization wide programmes with budget management
- Excellent strategic thinking and leadership abilities
- Excellent management, negotiation, and advocacy skills
- Excellent ability to exercise high degree of independence to ensure programme delivery and explore new areas of activities
- Excellent ability to interact with internal and external stakeholders
- Excellent ability to lead and motivate a team for optimum performance
- Good knowledge of Drug Discovery/Development
- Very good knowledge of Clinical Research/Development
- Very good knowledge of Regulatory (GCP, GLP, and GMP)
- Excellent knowledge of disease/academia knowledge
- Excellent Technical writing skills (procedures, protocols, and reports)
MD is mandatory, Master degree or Ph.D. in relevant field is an advantage
- Fluency in English
- Proficiency in local languages desirable
- Willingness and ability to travel globally
- This role has a reporting line into the R&D Director of DNDi with exception of the Patient Safety responsibilities, where the MD reports to the Executive Director of DNDi. The role will have a strong operational and strategic alignment with GARDP: the Executive Director, the R&D Director, and the Head of Clinical Affairs.
- There are a number of DNDi staff and or consultants and contractors working under the management of Medical Director e.g. Pharmacovigilance, Regulatory Affairs, and Quality Assurance
- There is no supervision or direct management of other DNDi staff engaged in clinical trials (e.g. Clinicians, Study, or Medical Managers.) to ensure segregation of duties between quality control and direct programme management.
- S/he works with R&D transverse teams and HIV/HCV, NTD initiatives as well as GARDP
- S/he represents DNDi at the highest level and interacts with governing bodies, major donors and other leaders of influence. S/he creates networks and relationships to expand programme interaction and bring resources or expertise
- Status: full time – permanent role
- Deadline for application: Accepting applications until 19 July 2018
- Only shortlisted candidates will be contacted.