GARDP – Clinical Trial Manager, STI Programme

Geneva, Switzerland
[Closing date: November 30, 2017]
                                                                 

    

Established in 2003 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.

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.orgwww.gardp.org)

The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit research and development organization that addresses global public health needs by developing and delivering new or improved antibiotic treatments, while endeavoring to ensure sustainable access. Initiated and incubated through close collaboration between WHO and Drugs for Neglected Diseases initiative (DNDi), GARDP is part of the implementation of the Global Action Plan on Antimicrobial Resistance that calls for new public-private partnerships for encouraging research and development of new antimicrobial agents and diagnostics.

GARDP’s mission is to work in partnership with the public and private sectors, to develop and deliver new treatments for bacterial infections where drug resistance is present or emerging, or for which inadequate treatment exists.

GARDP is currently hosted and facilitated by DNDi, which provides the scientific environment, necessary personnel, and infrastructure to ensure an effective start-up phase.

 

Purpose of the position

Gonorrhea is one of the most common Sexually Transmitted Infections (STIs), affecting 78 million people every year. The Western Pacific and African regions have the highest incidence of gonorrhea, with 89 and 50 cases per 100’000 population respectively. In the USA it causes 400’000 infections per year and is the second most frequently reported notifiable infectious diseases. There are serious concerns, articulated by the WHO and others, over the spread of resistant gonorrhea. Neisseria gonorrhoeae, the causative agent of gonorrhea, has been included as one of three organisms presenting an urgent threat by the US Center for Disease Control (US CDC) and is listed as a “high priority” pathogen in the WHO Global priority list of antibiotic-resistant bacteria.

Single dose antimicrobial monotherapy has been the mainstay of gonococcal infections management for long. But in the face of increasing resistance, and in particular in view of the rise in the number of treatment failures with extended-spectrum cephalosporins, several countries have recently adopted a dual therapy in their treatment guidelines. In Canada, Europe, South Africa and Australia, where failure with monotherapy has been noticed, the recommended first-line treatment for gonorrhea is Ceftriaxone + Azithromycin. However, resistance to Ceftriaxone and Azithromycin have started to emerge globally, and new treatments that tackle Multi-Drug Resistant (MDR) gonorrhea are urgently needed.

To address the rising concern of drug-resistant gonorrhea GARDP has partnered with Entasis Therapeutics to develop and register Zoliflodacin, a new chemical entity with high activity against Neisseria gonorrhoeae. Zoliflodacin is a first-in-class drug (spiropyrimidinetrione) that inhibits bacterial topoisomerase II and shows in vitro antibacterial activity against several STI pathogens. To date, three clinical trials have been completed: a phase I single-ascending dose trial, a phase I Absorption, Distribution, Metabolism, Excretion (ADME) trial and a phase II study involving patients with confirmed uro-genital gonococcal infection.

 

Specific job responsibilities

To coordinate all clinical trial related activities ensuring: Through

  • respect of the rights, the safety and the protection of the persons participating in any clinical trial.
  • adherence to applicable regulations and guidelines, and of the clinical trial protocol.
  • The accuracy, completeness, consistency with the source data collected.
  • Compliance with the objectives, the planning, the timelines and the clinical trial budget.

Main tasks

Project management

  • Planning, set-up and follow-up of the clinical trials.
  • Follow-up clinical trials progress: monitor milestones, communicate clinical trial progress to the project team.
  • Selection and management of subcontractors together with the Project Leader.
  • Management of clinical budgets and invoices.
  • Development of clinical trials tools.
  • Interaction with external boards (e.g. Advisory Panel).
  • Provide progress reports to Project Leader for STI Programme on individual projects including budget updates on a regular basis.

Trial design and set-up

  • Coordinate the development and secure approval of the clinical trials documents (Clinical Trial Protocol, Statistical Analysis Plan, Data Management Plan, Informed Consent Documents, Case Report Form).
  • Management of the clinical trial set-up and team:
    • Supervise all administrative steps (e.g. submission to Competent Authorities and Ethics Committees…).
    • Support investigators’ selection and organization of Investigators’ Meeting.
    • Supervise trial logistics coordination (with the Clinical Research Assistant – CRA).
  • Liaison with the CRAs/subcontractors for appropriate trial site set-up.
  • Supervise maintenance of the clinical trial documentation.

Regulatory compliance

  • Ensure clinical trial compliance with GCP and other applicable regulatory requirements (e.g. US-FDA and EMA).
  • Supervise preparation of regulatory documentation.
  • Prepare and review clinical SOPs and other standard documents required for clinical trials.
  • Contribute to the set up and review of GARDP systems related to clinical operations as appropriated.

Clinical trial follow-up and reporting

  • Follow-up of the trial allocated budget.
  • Liaison with the CRAs/subcontractors for appropriate site monitoring.
  • Management of possible protocol amendments and other follow-up issues during clinical trials.
  • 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.
  • Supervise maintenance of the clinical trial documentation.

Projects review

  • Provide progress reports to the Project Leader  of the STI Programme and senior management members on individual projects including budget updates, on a regular basis.
  • Assist in the preparation of materials for presentation to the Scientific Advisory Committee (SAC) and other interim and formal reviews.

Reporting line

  • S/he reports to the Project Leader of the STI Programme.

Interactions

  • Works within the GARDP STI Programme team, and interacts with the DNDi pharmaceutical development, QC and PV teams, as well as external service providers.
  • S/he has a representational role through the promotion of programmes and maintain productive relationships by projecting the image of a credible partner.

 

Job requirements

Skills and attributes

  • Strong ability to act on own initiative, prioritize, multi-task, and work well under pressure to meet deadlines.
  • Clear and systematic thinking that demonstrates good judgment and problem-solving competencies.
  • Strong communication skills in multicultural, multi-lingual environments.
  • Strong ability to work effectively as part of a multicultural team.
  • Well organized and structured.
  • Strong analytical skills.
  • Strong ability to provide high level support in project/programme delivery.
  • Strong ability to manage medium/large projects with budget management.
  • Has autonomy for taking actions and decisions.
  • Strong ability to interact with external stakeholders.
  • Lead and motivate a small team for optimum performance, supervising junior staff.

R&D technical skills

  • Excellent knowledge of the applicable clinical trial regulations and good clinical practices,
  • Knowledge of the laboratory requirements for clinical trials.

Experience

  • Minimum six years’ clinical trial management experience.
  • Proven ability to work effectively in a team environment and matrix structure.
  • Experience of managing external partners eg CRO.
  • Experience of managing US-FDA regulated trials is highly desirable.

Education

  • Advanced post-graduate degree or graduate degree in scientific/ healthcare discipline.

Other requirements

  • Fluency in English.
  • Position based in Geneva with frequent travels to Asia, Africa, US and Latin America.
  • Status: (Full time – Permanent role).

 

To apply

  • Deadline for application: Accepting applications until November 30th.
  • Only shortlisted candidates will be contacted.