Senior Translation Consultant

New Delhi, India
[Closing date: 17 March 2020


The 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 (

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

Reporting to the Head of Translational Sciences, the Senior Translation Consultant is responsible for advancing the development of new drugs from preclinical research to early clinical development and assessing clinical pharmacology, working closely with Discovery, Pharmaceutical Development, and Diseases teams. The position will strengthen the quality and progress of DNDi’s clinical candidates.


Specific job responsibilities

  • Provide input/develop First-in-Man (FIM) and clinical pharmacology programmes and protocols for candidate therapeutics
  • Contribute to Phase I clinical projects as Medical Responsible and liaise with Pharmacovigilance, Medical Director, and Medical Affairs as required
  • Deliver quality decision points and risk mitigation for project progression into completion of Phase I programmes and as required, collaborate with Heads of Disease in the development of the clinical strategy and contribute to the Clinical Development Plans
  • Together with the Clinical Project Manager (CPM), contribute to implementation and management of external studies with clinical CROs and investigators according to International standards and DNDi‘s Standard Operating Procedures (SOPs) in support of portfolio projects (collaborating on experimental design, contracting, compliance, material transfers, Regulatory submission, etc.) in relation with Phase I studies
  • Participate to site/CRO selection through bidding process and contribute to Clinical Trial Application submissions to Competent Authorities and Ethics Committees (set-up phase)
  • Together with the CPM, ensure adequate document control for all trial documents, monitor milestones, compliance, and budget, and present the clinical trial progress to applicable team
  • As medical responsibilities (responsibilities of Study Medical Responsible)
    • Define the Medical Review Specification (MRS) contained within the Medical Monitoring Plan and the Data Management Plan
    • Produce the Medical Monitoring Plans for Phase I studies, with support from the CPM, Head of Disease, Head of Translational Sciences (as appropriate), Pharmacovigilance function, Data Management, and other functions as required
    • Perform medical monitoring of Phase I trials according to the medical review specifications
    • Ensure the appropriate safety management by clinical trial teams as defined in study protocols, and medical monitoring plans, in compliance with the trial-specific safety management plan and DNDi‘s SOPs
    • Participate as a member of Safety Review Committee for FIM studies to review safety and pharmacokinetics data and decide about dose-escalation
    • She/he has a dotted reporting line to the Medical Director of DNDi
  • Represent Translational Sciences function in assigned projects and cross-functional teams and acts as subject matter expert for the development team to:
    • Contribute to the development of clinical protocols, informed consents, sample collection manuals, as well as regulatory documents required for initiation of Phase I studies, and provide input to Investigator Brochures and dossiers for interactions with Agencies
    • Provide the high-quality review and interpretation of study outcomes for assigned studies and oversee the presentation thereof in clinical study reports, and related study documentation to varied teams and governance audiences
    • Collaborate with colleagues in R&D team to advance internal research and early development projects
    • Interface with preclinical and/or clinical collaborators/partners as appropriate
    • She/he is part of Disease Extended teams
  • Support ongoing academic and industry collaborations and any future Open Innovation initiatives through review of proposals, development of full proposals with investigators, and collaborating with investigators on successful proposals
  • Support Fundraising team, as applicable (e.g. coordinate work package/grant, provide updates for donor reports). Participate in management of partner relationship
  • Together with the CPM, report Major and Critical Deviations to the QA unit and develop or review the CAPA, in addition to informing the direct manager, perform an Investigation and Root Cause Analysis in case the significance of the deviation is confirmed by QA and oversee the implementation of all CAPAs
  • Participate to interim and final data analysis, coordinate with the CPM data base lock(s), and release of results (e.g. data cleaning, medical review)
  • Contribute to Clinical Study Reports (CSR), including its appendices, review drafts, and approve final CSRs
  • Review scientific publications and participate in publication release and result presentations in international congresses, as applicable
  • Maintain a strong understanding and awareness on new and emerging medical and diagnostic development
  • Liaise with the internal and external medical and R&D community to follow developments within disease areas of interest to R&D
  • Interact with team members in a matrixed environment that includes subject matter experts in clinical, clinical operations, project management, data management, biostatistics, regulatory, commercial, manufacturing, and discovery research
  • Organize project teams and manage external consultants, contractors, and collaborators, as required
  • S/he is a member of the Management team in the regional office


Reporting line

  • S/he reports to the Head of Translational Sciences and has dotted lines to the Indian Office Head and to the Medical Director


Job requirements

Skills and attributes

  • Very strong ability to use initiative, to prioritize, to be multi-task, and work well under pressure to meet deadlines
  • Very clear and systematic thinking that demonstrates strong judgment and problem-solving competencies
  • Very strong communication skills in multicultural, multi-lingual environments
  • Very strong ability to work effectively as part of a multicultural team
  • Very well 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
  • 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
  • Ability to lead and motivate a team for optimum performance, supervising junior staff

Technical skills

  • Drug development: A broad knowledge of preclinical and early clinical (Phase I/II) development
  • Demonstrated ability to effectively apply technical principles, theories, and concepts, preclinical study designs, and clinical drug development
  • Proven track record in the clinical space:
    • Qualification in clinical pharmacology and its application to early clinical development
    • Experience in interacting with regulatory agencies (e.g. FDA, EMA, DCGI)
    • Experience in biomarker/NCE data analysis in the context of mechanism of action studies
  • Familiar with pharmaceutical regulatory requirements, documentation, and processes for major international agencies
  • Track record in development, implementation, and execution of early clinical development strategy for novel drug candidates, from clinical candidate approval through clinical proof-of-concept

R&D technical skills

  • Excellent knowledge of drug discovery/development
  • Excellent knowledge of clinical research/development and clinical pharmacology
  • Excellent knowledge of Regulatory (GCP, GLP and GMP)
  • Strong knowledge of disease/academia knowledge
  • Excellent technical writing skills (procedures, protocols, and reports)


  • Over 8 years in senior role
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of working in public and private sector is highly desirable


  • Medical Doctor
  • Advanced post graduate degree in Clinical Pharmacology is a plus

Other requirements

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


Other information

  • Status: full time – 2 years consultancy agreement           


To apply

  • Deadline for application: accepting applications until 17 March 2020
  • Only shortlisted candidates will be contacted 
  • Application submission for this position may close early if we have enough suitable applicants