Neonatal Sepsis (NeoAMR) Project Leader

Global Antibiotic Research and Development Partnership
Geneva, Switzerland

[Closing date: 14 August 2016]

Background

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. GARD 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, GARD will:

  • address global public health and specific 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.

 

The NeoAMR project

One of the key start-up projects that GARD is currently preparing for launch by the end of the year is the NeoAMR project. NeoAMR 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 through the following objectives:

  • Design and conduct pharmacokinetic, observational and interventional studies in high MDR setting to determine efficacy and safety of new empiric regimens compared to existing therapies
  • Develop a global network of neonatal infection centres/experts to design and conduct studies on optimal management of off patent antibiotics & other interventions in neonatal sepsis with MDR pathogens
  • Determine a method for appropriate use of empiric antibiotic regimens for the management of neonatal sepsis in settings with varying prevalence of MDR pathogens.

Project leader responsibilities:

The NeoAMR Project Leader will be involved in the coordination, support and documentation of the projects throughout all stages of the development process, with particular focus on the development of improved regimens, the clinical phase, through to inclusion in country EMLs and conservation and access strategies. As a Project Leader s/he will be expected to maintain frequent interaction with the key external expert driving the project and various teams involved in the project. S/he will report to the Director of GARD and work closely with the project initiator (an external partner) and the Chair of GARD’s Scientific Advisory Committee (a consultant).

 

Specific job responsibilities:

Develop project plans

  • Develop project schedules and budgets
  • Interact with all project partners on a regular basis to track activities and progress, and identify in a timely manner problems or deviations from the project schedule that need to be addressed.
  • Monitor milestones, critical success factors, and key performance indicators for project evaluation
  • To help in the creation, animation and coordination of the Neonatal Sepsis Expert Working Group
  • Ensure regulatory compliance for projects
  • Ensure projects follow best practice and regulatory compliance and keep appropriate documentation.

Manage and Develop Systems for Projects

  • Set up project management and data management systems to support the project
    Collect data and information (in particular ongoing external studies, published data in journals or presented at conferences, meetings with stake holders of the civil society, scientists, and pharmaceutical partners)
  • Interact with key partners on a regular basis to ensure that projects meet their milestones
  • Provide logistical support and tracking for all trial materials with the trial monitors, trial managers and site investigators.
  • Write a monthly update project and help with biannual project reviews and reports to Scientific Advisory Group
  • Work closely with the fundraising team to ensure effective grant proposals as well as reporting.

Ensure regulatory compliance for projects

  • Responsible for all project-related clinical development documentation and be familiar with pharmaceutical regulatory requirements, documentation and processes for major regulatory agencies with a view to the eventual registration of the new treatment.
  • Ensure the projects follow international GCP, SOPs and other relevant regulations, and keep and organize the documentation to that end

Enable review of projects

  • To update GARD executive team on progress and budgets on a regular basis and present interim reviews
  • Assist in the preparation of meetings and materials for presentation in internal and external meetings
  • Advise on systems that enhance the review process as required

Qualifications

  • Strong experience in coordination of programs ideally in the biotech / pharmaceutical industry. Preferably experienced in clinical trials in high and low-income settings, and in neonates.
  • S/he will have high level qualification in one or more of the relevant disciplines with a proven record of organizational and IT skills. S/he will also have high-level interpersonal skills and an ability to interact with and coordinate international research collaborations.
  • Ability to work independently and drive initiatives to improve project performance
  • Linguistic skills: Fluent English
  • Location and travel: The position is based in Geneva and involves regular international travel to meet our partners.
  • This is a new 1.0 FTE contract position from 1 October 2016.

 

To apply

  • For additional information about DNDi please visit our website at www.dndi.org/GARD.
  • Accepting applications until 14 August 2016.
  • Only shortlisted candidates will be contacted.