Senior Clinical Manager HCV

Geneva, Switzerland
[Closing date: October 15, 2017]
                                                                 

 

Established in 2003, the Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development (R&D) organization that develops new, improved, and affordable medicines for deadly neglected diseases that afflict millions of the world’s poorest people.

DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. 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 organization to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all.

Since its inception, DNDi has developed seven new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, paediatric HIV with several new drug candidates in the R&D pipeline including two for sleeping sickness. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.

The HIV/HCV team aims to develop two solid first-line “4-in-1” fixed-dose combinations using the World Health Organization (WHO) recommended treatment regimen for HIV positive infants and young children. At the same time, DNDi and its partners in South Africa are also addressing the negative drug-drug interactions between WHO-recommended HIV treatments and the TB drug rifampicin through a process known as “super-boosting.” To address hepatitis C patients’ needs, the team’s objective is to develop an affordable public health tool using direct-acting antivirals (DAAs).        

 

Purpose of the position

The Senior Clinical Manager HCV, will play an important role in the development of new drugs and treatments for neglected diseases. S/he will be involved in the coordination, support and documentation of projects throughout all stages of the development process, with particular focus on the clinical phases. As a Senior Clinical Manager, s/he will report to the Clinical Trials Leader in the DNDi HIV/HCV team.

 

Specific job responsibilities

Develop project plans

  • To develop project protocol, project schedules and budgets with the clinical team and the investigators
  • To monitor milestones for project evaluation with the Clinical Trial Lead
  • To play a full role in the R&D team and to be an active member of the DNDi organization
  • To implement collaborative partnership programmes with third party organizations such as MSF

Ensure regulatory compliance for projects

  • To ensure training of partners on pharmaceutical regulatory requirements, documentation, and processes for major international agencies
  • To ensure projects follow GCP, and regulatory compliance and keep appropriate documentation
  • To participate in preparing regulatory documentation
  • To ensure inspection readiness for projects contributing for a registration
  • To prepare and review clinical SOPs and other standard documents required for clinical trials
  • To contribute to set up and to review of DNDi systems related to clinical operations as appropriate
  • To ensure that targets set within the local and global quality management plan are met

Manage and develop project reporting systems

  • To collect data and information to enable the Head of disease area and/or Clinical Trial Leads and the R&D Director to make effective and cost-efficient use of DNDi resources
  • To interact with study site teams on a regular basis to ensure that projects meet their milestones
  • To provide logistical support and tracking for all trial materials with the trial monitors, trial managers, and site investigators
  • To liaise with the project consultants and collaborators within the project network
  • To write a monthly project update, when requested

Enable review of projects

  • To provide progress reports to the Paediatric HIV/HCV Clinical Trial Leader and senior management members on individual projects including budget updates, on a regular basis
  • To assist in the preparation of materials for presentation to the Scientific Advisory Committee (SAC) and other interim and formal reviews

Personal

  • To develop and maintain the skills required for delivery of all aspects of clinical trials
  • To maintain an awareness of all developments in the designated neglected diseases that relate to drug development and disease control
  • To be aware of developments in clinical development and the regulatory environment, and report these to DNDi
  • To actively contribute to a collaborative, open and inclusive working environment with DNDi colleagues and project stakeholders

Reporting line

  • S/he reports to the Paediatric HIV/HCV Clinical Trial Leader

Interactions

  • Works with rest of the HIV/HCV team, and other transversal R&D units (Medical Affairs, Pharmaceutical Development)

 

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

R&D technical skills

  • Excellent knowledge of Clinical Research/Development in an international environment
  • Excellent knowledge of International Regulatory (GCP, GLP, and GMP)
  • Good knowledge of HCV /infectious disease
  • Excellent technical writing skills (procedures, protocols, and reports)
  • Good knowledge of inspection preparation
  • Good knowledge of document preparation for drug registration

Experience

  • Over 8 years in a senior role in clinical R&D and 5 years in a project management 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

Other requirements

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

Other information

  • Status: (Full time – Permanent role)  

 

To apply

  • Deadline for application: Accepting applications until October 15th
  • Only shortlisted candidates will be contacted