[Closing date: October 31, 2017]
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 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.
In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research and Development Partnership, a not-for-profit research and development initiative to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all.
To achieve its long-term goal of combinations of new orally-active drugs to cure neglected diseases and fight resistance, DNDi is establishing a robust and dynamic pipeline of drug candidates. DNDi’s late-stage portfolio is evolving from a focus on combinations of older drugs aiming to improve the management of patients, to new orally-active drugs developed alone or in combination with older drugs to support elimination strategies. The R&D portfolio has grown from 4 projects in 2003 to more than 32 in 2017, with a pipeline spanning seven disease areas, including 15 new chemical entities (NCEs).
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 are 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
The Head of Regulatory Affairs provides strategic regulatory guidance. S/he oversees and manages global regulatory activities for the DNDi portfolio in collaboration with the project teams in order to ensure timely availability to the patients where they need treatments, and interacts effectively with several partners and stakeholders to ensure that DNDi’s mission is fully reflected in the agreed regulatory strategy.
Specific job responsibilities
- Act as an in-house regulatory expert, advising and supporting the disease teams
- Together with DNDi management and external stakeholders, support consistent regulatory strategy by regulatory authorities (stringent, NRAs, WHO prequalification, etc.)
- Lead the implementation of global regulatory strategies taking into consideration the overall development programme objectives under the disease leadership
- 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 disease team leaders
- Coordinate with pharmaceutical partners to ensure that regulatory strategies and activities are consistent with the development programme objectives of DNDi’s projects in line with our mission
- 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 global regulatory requirements
- Develop knowledge on the global regulatory environment and trends. Contribute shaping and implementing DNDi policy position in this field (e.g. mutual recognition, accelerated pathways, incentive mechanisms…)
- Participate in any relevant product planning review when called by the disease initiatives
- Participate in opportunity assessment to provide regulatory input on potential new projects with partners
- Contribute to DNDi relevant technical, management and governance committee (Leadership meetings, Scientific Advisory Committees, etc.)
- Conduct and share regulatory intelligence for DNDi
- S/he reports to the Medical Director
- S/he works with assigned disease teams and Heads of Programmes to deliver new treatments for neglected diseases in the DNDi portfolio
- S/he acts as a credible voice of the organization for a programme area, identifying opportunities to represent DNDi and position the programme to be recognized as leaders in the field. S/he develops and maintains partnerships and networks
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 skills in multicultural, multilingual environments
- Knowledge of managing global multicultural teams
- Highly organized and structured
- High analytical skills
- High ability to lead large strategic projects
- Very strong strategic thinking and leadership abilities
- Excellent management, negotiation, and advocacy skills
- High ability to interact with internal and external stakeholders
- High ability to lead and motivate a team for optimum performance
R&D technical skills
- Excellent knowledge of Regulatory environment (ICH, different regulatory mechanisms and authorities, GCP, GLP, and GMP)
- Minimum 12 years’ regulatory experience in pharmaceutical development
- Strong working experience with a variety of regulatory authorities is required, with real first-hand experience of managing registrations with different regulatory authorities
- Experience in leading and managing complex/virtual networks suppliers and partners to deliver and maintain regulatory approvals is essential
- Proven track record in influencing and shaping optimal regulatory outcomes
- Experience with regulatory authorities
- Proven ability to work effectively in a team environment and matrix structure is critical
- Experience building and leading teams in a start-up environment
- Professional experience as part of a regulatory agency would be useful
- MD, Master degree or PhD in relevant field
- Fluency in English
- Proficiency in local languages desirable
- Willingness and ability to travel globally
- Excellent knowledge of Microsoft Suite
- Status: (Full time – Permanent role)
- Deadline for application: Accepting applications until October 31st.
- Only shortlisted candidates will be contacted.