Senior Translation Manager

Geneva, Switzerland
[Closing date: 17 June
2019]

 

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

Reporting to the Head of Translation, the Senior Translation Manager is responsible for advancing the development of new drugs from pre-clinical research to clinical development, working closely with Discovery, Pharmaceutical Development, and Disease area teams. The position will strengthen the quality and progress of DNDi’s clinical candidates.

 

Specific job responsibilities

  • Advance the development of investigational drugs by implementing strategies to bridge pre-clinical research with clinical development and support clinical trials with pharmacodynamic/biomarker
  • Provide input in understanding the mechanism(s) of action of DNDi’s therapeutics and candidate therapeutics and develop FIM and Clinical Pharmacology programme accordingly
  • Develop and lead pre-clinical and Phase I clinical project plans through internal or external resourcing
  • Deliver quality decision points and risk mitigation for project progression through pre-clinical and into completion of the Phase I programme and as required, collaborate with Head of the Disease in the development of the clinical strategy
  • 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
  • Implement and manage all aspects of external studies with clinical CROs and investigators in support of portfolio projects (collaborating on experimental design, contracting, compliance, material transfers, regulatory submission, etc.) in relation with Phase I studies and be accountable for the study budget
  • Participate to site/CRO selection through bidding process and contribute to the Clinical Trial Application submission to Competent Authorities and Ethics Committees (set-up Phase)
  • 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)
    • S/He produces the Medical Monitoring Plans for Phase I study, with support from the CPM, HDCP, Head of Translation Sciences (as appropriate), Pharmacovigilance function, data management, and other function as required.
    • S/He defines the Medical Review Specification (MRS) contained within the Medical Monitoring Plan and the Data Management Plan
    • S/He performs the medical monitoring according to the medical review specification
    • S/He contributes to the appropriate safety management by clinical trial teams as defined in the protocol, monitoring plan, and medical monitoring plan (if any) in compliance with the trial-specify safety management plan
    • S/He participate as a member of Safety Review Committee to review safety and pharmacokinetics data and to decide as required about dose-escalation
    • S/He will have a dotted reporting line to the Medical Director
  • Represent Translational function in assigned projects and cross-functional team and act as subject matter expert for the development team:
    • Lead the development of clinical protocols, informed consents, sample collection manuals, as well as regulatory documents for Phase I studies as well as provide input to Investigator Brochures and dossiers for Agency interactions
    • 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 team and governance audiences
    • Collaborate with colleagues in R&D team to advance internal research and early development projects
    • Interface with pre-clinical and/or clinical collaborators/partners as appropriate
    • Be part of the Disease Extended Teams
  • 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
  • Interacts 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
  • Support fundraising team, as applicable (e.g. coordinate work package/grant, provides updates for donor reports.
  • Report Major and Critical deviations to the QA unit and develops or reviews 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 oversees the implementation of all CAPAs
  • Participate to interim and final data analysis, coordinate data base lock(s), and release of results (e.g. data cleaning, medical review)
  • Ensure the appropriate safety management by clinical trial teams as defined in the protocol, monitoring plan, and medical monitoring plan (if any) in compliance with the trial-specify safety management plan
  • Contribute to Clinical Study Reports (CSR), including its appendices, drafts, reviews, and approves final CSRs
  • Review scientific publication, and participate in publication release and results presentation in international congress, as applicable
  • Participate in management partner relationship

 

Job requirements

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
  • 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
  • Lead and motivate a team for optimum performance, supervising junior staff
  • Drug Development: A broad knowledge of early clinical (Phase I/II) development
  • Demonstrated ability to effectively apply technical principles, theories, and concepts, pre-clinical study designs, and clinical drug development
  • Proven track record in the clinical space:
    • Qualification in pharmacology and its application to early clinical development
    • Experience in interacting with regulatory agencies (e.g. FDA, EMA)
    • 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 pre-clinical candidate approval through clinical proof-of-concept

R&D technical skills

  • Excellent knowledge of Drug Discovery/Development
  • Excellent knowledge of Clinical Research/Development
  • Excellent knowledge of Regulatory (GCP, GLP and GMP)
  • Strong knowledge of Disease/academia knowledge
  • Excellent technical writing skills (procedures, protocols and reports)

Experience

  • 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

Education

  • Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level
  • Medical doctor

Other requirements

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

 

Reporting line

  • S/he reports to the Head of Translational Sciences

 

Other information

  • Status: full time – permanent role

 

To apply

  • Deadline for application: Accepting applications until 17 June 2019
  • Only shortlisted candidates will be contacted
  • This position might close early if we receive good applications.