GARDP – Senior Clinical Manager

Geneva, Switzerland
[Closing date: 14 October 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 & 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.

 

Currently two disease-specific projects are under development:

Neonatal sepsis: While major inroads have been made in reducing under 5 mortality, under one-month mortality remains a major problem, with AMR a particular threat. This project aims to develop and deliver a new first line treatment for pathogens causing neonatal sepsis as well as a new treatment for multi-drug resistant pathogens. These new, globally applicable, empiric antibiotic regimens and strategies for the treatment of neonatal sepsis target settings with varying prevalence of multidrug-resistant (MDR) pathogens. The project will design and conduct studies in high MDR setting(s) to determine efficacy and safety of new empiric regimens compared to existing therapies; and build a global network of neonatal infection centres and experts to guide studies and advise on optimal empiric management of MDR infections. Two product profiles have been developed to guide the project.

Drug-resistant gonorrhoea: Over the past few year serious concerns have been raised globally over the spread of resistant gonorrhoea. Neisseria gonorrhoeae is evolving into a superbug and will soon become untreatable due to its resistance to all classes of antimicrobials available. The project will seek to develop and deliver two new treatments for gonorrhoea patients with drug resistant infections, notably by combining existing antibiotics and by exploring entirely new drugs that are in development. The ultimate aim of the project is to have treatments for i) drug resistant forms of the disease, ii) syndromic management of STIs in areas with high background of drug resistant gonorrhoea, and iii) alternative treatments for the most complicated forms of gonorrhoea. Currently there are no dedicated programmes targeting all three strategies, though there are efforts focused on developing and registering new treatments for uncomplicated gonorrhoea. Two target product profiles have been developed to guide the project.

 

Senior Clinical Manager Responsibilities

The Senior Clinical Manager will support the implementation of disease specific projects, beginning with Neonatal Sepsis and gonorrhoea, throughout all stages of the development process, with particular focus on the development of improved regimens and the clinical phases. As a Senior Clinical Manager, s/he will be expected to set up and execute the clinical aspects of these, and other new projects and will report to the NeoAMR Project Leader and will work closely with senior members of the GARDP management team.

 

Specific Job Responsibilities

Project Management

  • Planning, set-up and follow-up of the clinical trials
  • Liaise with CROs and academic groups on behalf of sponsor
  • Follow-up of the clinical trial progress: monitor milestones, compliance with the recording deadlines, presentation meeting of the clinical trial progress to the project team
  • Follow-up of the subcontractors and partners during the clinical trial
  • Management of clinical budgets and invoices
  • Development of clinical trial tools
  • Interaction with Data and Safety Monitoring Board Members
  • Provide progress reports to Head of Disease Program on individual projects including budget updates on a regular basis.

 

Clinical Trial Design

  • Finalize the development and secure approval of the clinical trial documents: Clinical Trial Protocol, Statistical Analysis Plan, Data Management Plan, Informed Consent Documents, Case Report Form…
  • Coordination of the clinical trial documentation.

 

Clinical Trial Set-up

  • Management of the clinical trial set-up and team
  • administrative steps (e.g. submission to Competent Authorities and Ethics Committees…)
  • investigators’ selection and Investigators’ Meeting
  • coordination of the logistics (sending the Investigational Medicinal Products to the trial sites)
  • Liaison with the CRAs/Trial Coordinator for appropriate trial site set-up
  • Maintenance of the clinical trial documentation

 

Clinical Trial Follow-up and Clinical Trial Report

  • Follow-up of the trial allocated budget
  • Liaison with the CRAs for appropriate site monitoring
  • Coordination of the clinical trial logistics (sending, return, destruction of the study supplies)
  • Management of possible Clinical Trial Protocol Amendments, other follow-up issues and possible administrative steps (e.g. submissions to Competent Authorities and Ethics Committees) during the clinical trial
  • Management of the Serious Adverse Events and other safety issues during the clinical trial
  • Follow-up of the subcontracted data management and statistical activities
  • Notification of the end of the clinical trial
  • Coordination of the development of the Clinical Study Report and its appendices
  • Maintenance of the clinical trial documentation.

 

Qualification Required

  • Experience in clinical research (minimum 6 yrs in clinical trials) in high and low income settings
  • Knowledge in the applicable regulation for clinical trials and in Good Clinical Practices.
  • Ability to manage projects and to conduct meetings.
  • Fluent in English, knowledge of French is a plus.
  • Position based in Geneva with international travel.
  • PhD or advanced degree in relevant field.
  • High level qualification in one or more of the relevant disciplines with a proven record of organizational and analytical skills.
  • High-level interpersonal skills and an ability to interact with and coordinate international researchers.
  • Ability to work independently and drive initiatives to improve project performance

 

This is a new 1.0 FTE contract position from 1 December 2016.

 

To apply

  • Deadline for application: Accepting applications until October 14th, 2016.
  • Only shortlisted candidates will be contacted.