[Closing date: 20 December 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 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 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 Nonclinical Development Senior Manager will be the expert point of contact for all Nonclinical activities conducted by DNDi in our collaborative virtual model working with our network of CROs, pharmaceutical companies, and expert consultants.
Specific job responsibilities
- Works with project teams to agree selection and design of safety and toxicology studies for development candidates
- Collaborates with Business Development, Procurement, and Legal teams to evaluate and appoint providers of studies
- Manages safety and toxicology studies according to planned timelines and budgets
- Ensures studies are performed to necessary regulatory and GLP standards
- Reviews results, gathers expert feedback from consultants and partners, and presents results and recommendations to DNDi leadership, Scientific Advisory Committee, partners, etc.
- Writes/reviews reports and presentations for internal (e.g. SAC report, bimonthly update, annual report), and external needs (e.g donors). Authors scientific publications and presentations.
- Prepares nonclinical summaries and contributions to regulatory documents (e.g. IB, IMPD, IND, CTD, scientific advice briefing packages)
- Provides advice and support across the DNDi portfolio
- Develops internal systems and external networks for the efficient and effective management of nonclinical studies
Skills and attributes
- Very strong 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
- Very strong ability to work effectively as part of a multicultural cross-functional team
- Highly organized and structured
- Very strong analytical skills
- Very strong ability to lead project delivery
- Very strong ability to manage large size projects with budget management
- Very strong strategic thinking and leadership abilities
- Very strong management, negotiation, and advocacy skills
- Very strong ability to exercise high degree of independence to support programme delivery and explore new areas of activities
- Very strong ability to interact with internal and external stakeholders
- Lead and motivate a team for optimum performance
R&D technical skills
- Excellent knowledge of nonclinical development
- Excellent knowledge of regulatory (GLP and GMP)
- Excellent knowledge of drug discovery, translation, and development
- Excellent Technical writing skills (procedures, protocols and reports)
- Certification as a toxicologist is desirable
- Project management certification desirable
- Over 8 years in senior role managing/leading GLP compliant bonclinical Development activities, including safety pharmacology, toxicology, genetic toxicology. and carcinogenicity studies
- Has supported projects in late discovery, translation, and clinical stages with a variety of exploratory, investigational, and GLP studies
- Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level
- BSc/MSc degree in toxicology, safety pharmacology, or other relevant discipline
- Fluency in English
- Proficiency in local languages desirable
- Very good knowledge of Microsoft Suite
- Familiarity with working in/with the pharmaceutical industry
- S/he reports to the Head of Translational Sciences
- Work closely with the Head of Pharmaceutical Development and the Discovery Director
- Status: full time – permanent role
- Deadline for application: Accepting applications until 20 December 2018
- Only shortlisted candidates will be contacted