GARDP – Clinical Research Associate

Geneva, Switzerland
[Closing date: March 3, 2017]

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).

WHO and the Drugs for Neglected Diseases initiative have collaborated over the past two years on the creation of a 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. DNDi has agreed to facilitate the set up and hosting of the partnership and provide the scientific environment, necessary personnel and infrastructure to ensure an effective incubation period. GARDP will work closely with all stakeholders in the field of antibiotic research and development (R&D) – including pharmaceutical and biotechnology companies, startups, other product development partnerships, academia, civil society, and health authorities – from countries of all income levels to develop new antibiotic treatments, with the aim of becoming an independent organization within a period of two years. Ultimately, GARDP will:

  • address global public health, with a particular awareness for needs of low- and middle-income countries, targeting products that industry will not develop due to lack of profitability
  • pilot the use of alternative incentive models that support conservation of and access to new antibiotics based on DNDi’s experience in implementing alternative R&D models for neglected diseases
  • ensure that new antibiotics are affordable to all

 

Overall Purpose

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 CRA, S/he will report to Project Managers in GARDP team and be responsible for monitoring and keeping track of GARDP resources for given projects.

Projects include the NeoAMR project which aims to develop new, globally applicable, empiric antibiotic regimens and strategies for the treatment of neonatal sepsis in settings with varying prevalence of MDR pathogens and the Sexually Transmitted Infections (STI) project, which aims to develop new treatments addressing the rise in MDR and XDR Gonorrhea while being suitable for integration in STI syndromic management.

 

Tasks and responsibilities

Develop project plans

  • To monitor project schedules and budgets with the Project Manager and the partners
  • To monitor milestones for project evaluation with the Project Manager
  • To play a full role in the R&D team
  • To be an active member of the DNDi/GARDP organization

Ensure regulatory compliance for projects

  • To be familiar with 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 participate in developing a quality management system and developing/reviewing SOPs

Manage and develop project reporting systems

  • To collect data and information to enable Project Managers and the R&D Director to make effective and cost-efficient use of DNDi/GARDP resources
  • Regular interaction with partners / CROs / study site teams to ensure that projects meet their milestones
  • To provide logistical support and tracking for all trial materials with partners, CRO and other members of the project team

Enable review of projects

  • To provide progress reports to Project Managers on individual projects
  • To assist in the preparation of materials for presentation to the Scientific Advisory Committee (SAC) and other interim and formal reviews

 

Additional /specific/projects responsibilities

Personal

  • To develop and maintain the skills required for delivery of all aspects of clinical trials
  • To maintain an awareness of developments in the designated projects that relate to drug development
  • To be aware of developments in clinical development and the regulatory environment, and report these to DNDi/GARDP

Reporting line

  • S/he reports to Neonatal Sepsis Project Leader
  • With functional reporting to the Senior Clinical Trial manager

Interactions

  • Works with R&D team, and other DNDi/GARDP departments including but not limited to finance
  • Collaborators, counterparts, and service providers are mainly in the functional area in and outside DNDi/GARDP to get information, guidance, and feedback or to enlist cooperation. Works on the organization of representation of DNDi/GARDP at smaller events and with external stakeholders of same equivalent level

 

Skills and attributes

  • 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
  • Very good communication skills in multicultural, multi-lingual environments
  • Ability to work effectively as part of a multicultural team
  • Well organized and structured
  • Very good analytical skills
  • Ability to contribute to the project delivery under minimum supervision
  • Ability to manage middle sized projects with budget management under supervision
  • Provide specialist services to operational line or project team
  • Ability solve non-routine problems on a case by case/project basis
  • Has certain autonomy for taking actions and decisions
  • Ability to interact with external stakeholders
  • Ability to be the focal point/manager for consultants
  • Ability to supervise at a smaller level

R&D technical skills

  • Knowledge of GCP and its application in clinical trial conduct

Experience

  • Minimum 6 years’ relevant experience in which at least 3 years at Officer level or equivalent
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of working in clinical research is required

Education

  • MSc or PhD in Life Science

 

Other Requirements

  • Fluency in English
  • Proficiency in local languages desirable
  • Good knowledge of Microsoft Suite
  • Work Location: Geneva
  • Travel Required: Up to 25 %

 

To apply

  • Deadline for application: Accepting applications until March 3, 2017.
  • Only shortlisted candidates will be contacted.