Drugs for Neglected Diseases Initiative Hiring for Translational Medicine Consultant at New Delhi, Delhi, India Full Time

Job Description

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 Translation Medicine Consultant plays a leading role in the early clinical development of new drugs and treatments for neglected diseases. Working as part of the global team, the Translation Medicine Consultant ensures that the team objectives are met and the activities are performed as per the timelines and in line with the guidelines of the country and regulatory framework.

Contribution

The role is accountable for managing smaller scale projects and/or parts of the projects and delivering quality output through expert services or people. The position will form part of the team working at capacity building for potential public Clinical Phase I sites in India and identify pathway to conduct Phase I study in India for DNDi molecules. This project aims at identification and developing Phase I sites in public centers to international translational research standards in India, to evaluate ongoing and evolving portfolio of compounds clinical candidates for diseases of public health importance for India and support the translational medicine team of DNDi to plan Phase I trials in India.

Scope of work

The role positively impacts the performance of assigned projects and teams or impacts on larger programmes and contribute to developing the capacity of early stage research in India and setting up best in class processes.

Specific job responsibilities

To coordinate with the global team and other stakeholders, including govt agencies, and carry out activities guaranteeing:

• To perform, coordinate, and evaluate existing and potential Phase I public site Capacity Building-related activities including:
  • Assessment of clinical sites (also private ones) – analyse both the technical (and if possible, also environmental) capabilities of existing Phase I centers in India, including existing infrastructures, human resources, networks and services. A full environment for Phase I capabilities would include biometrics services like Clinical Data Management, Statistical Analysis and Programming or Medical Writing capabilities
  • Closely work with Head of Translational Sciences and with DNDi team in New Delhi on evaluating the potential of public institute and recommending the pathway for establishing this capacity in the country
  • Closely work with Govt agencies
• Feasibility of conduct of Phase I studies in India for DNDi molecules
• Working with DNDi team to plan webinars

Capacity building and early clinical development trial planning:

• Plan, coordinate, evaluate, and assess technical capabilities of existing and potential Phase I centers in India
• Draft internal visit reports to be circulated to Global and local teams, comprising of Director South Asia Regional Office, Head of Translational Sciences, DNDi Strategic Advisor and up to head of R&D and Medical Director and highlight areas for improvement/gaps and a final report to be submitted t and prepare a final report to be submitted to the outside agencies
• Technical discussions with Potential Phase I sites and regulatory authorities for conduct of multiple ascending studies and other early development studies in India
• Represent DNDi in the forums for discussing translational research and arranging webinars on translational medicine & research by inviting subject and DNDi experts as knowledge sharing platform

Reporting line

• Reports to the Head of Translation Science, with a dotted line to Director South Asia Regional Office

Interactions

• Works with every disease department
• A representational role through the promotion of programmes and maintain productive relationships by projecting the image of a credible partner

Job requirements

Skills and attributes

• Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
• Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
• Strong communication skills in multicultural, multi-lingual environments
• Strong ability to work effectively as part of a multicultural team
• Well organized and structured
• Strong analytical skills
• Strong ability to provide high level support in project/program delivery
• Strong ability to manage medium/large projects, including budget management
• Strategic thinking and leadership abilities
• Strong management, negotiation, and advocacy skills
• Has autonomy for taking actions and decisions
• Strong ability to interact with external stakeholders
• Lead and motivate a small team for optimum performance, supervising junior staff
• Strong ability to work with partners like govt scientific departments and communicate effectively

R&D technical skills

• Very strong knowledge of Drug Discovery/Development
• Knowledge in the applicable regulation for clinical trials and in Good Clinical Practices and updated on latest regulations
• Very strong knowledge of Disease/academia knowledge
• Very strong Technical writing skills (procedures, protocols and reports)
• Prior experience of site assessment and selection

DNDi Leadership Competencies

• Orientation to developing others
• Strategic expertise
• Professional competence
• Care of relationships
• Leading by example
• Contextualised skillfulness

Experience

• Minimum 6 years’ relevant experience
• Proven ability to work effectively in a team environment and matrix structure and with partners / vendors
• Experience of working in public and private sector is highly desirable

Education

• PhD/ MBBS/ MD as academic qualification

Other requirements

• Fluency in English
• Proficiency in local languages desirable
• Very good knowledge of Microsoft Suite

Other information

• Status: Consultant
• Duration: 6 months

To apply

• Please submit your application using the online form
• Deadline for application: Accepting applications until 25 September 2021
• Only shortlisted candidates will be contacted
• Application submission for this position may close early if we have enough suitable applicants