GARDP Clinical Research Scientist, Senior Manager 80%

Geneva, Switzerland
[Closing date: 16 September
2018]                                                                 

 

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)

The Global Antibiotic Research and 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 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. (www.gardp.org)

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

The GARDP Clinical Research Scientist, Senior Manager will provide scientific project management for R&D programmes.

As a Clinical Research Scientist across all GARDP R&D programmes. S/he will provide scientific and clinical support to clinical trial activities, support public health objectives and manage cross functional enabling activities. S/he will support programme teams to implement and deliver the cross functional aspects of the programme by leading workstreams as requested and directed by the Programme Leaders, and where appropriate by the Head of Clinical Affairs and the R&D Director.

 

Specific job responsibilities

Project management

  • Planning, set-up, and follow-up of cross functional workstreams supporting programme and R&D objectives
  • Deliver evaluation activities as directed by Programme Leaders to support portfolio decisions
  • Project management of enabling science activities to support portfolio decision making
  • Selection and management of subcontractors together with Programme Leaders
  • Provide progress reports to Programme Leaders for STI individual programme workstreams including milestones and budget updates on a regular update

Clinical Trial Medical monitoring and safety support

  • Support Head of Clinical Affairs in all appropriate medical and safety aspects of GARDP clinical programmes
  • At study level provide safety monitoring support with overview provided by Head of Clinical Affairs
  • Provide clinical scientist support for oversight of study technical data reviews including patient inclusion and endpoint evaluation

Portfolio planning and control

  • Support the delivery of progress reports to R&D Director and Programme Leaders on individual projects including budget updates, on a regular basis
  • Assist in the preparation of materials for presentation to the internal GARDP management and governance, Scientific Advisory Committee (SAC), and external fora

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

Tasks and responsibilities for R&D staff

  • Provide scientific and project management to key R&D programme and portfolio workstreams
  • Support programme team to implement and deliver the cross functional aspects of the programme by leading workstreams as requested and directed by the programme lead and where appropriate by the Head of Clinical Affairs and the R&D Director
  • Provide specific scientific and clinical technical support to priority clinical trial activities – safety review, efficacy evaluation, data reviews, etc.
  • Support public health objectives for programmes by leading and supporting specific workstreams
  • Assist Programme Leaders and R&D Director in specific R&D planning and control activities

 

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 program 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

  • Significant experience in clinical development from industry or academia with a preference for antibiotic clinical development

Experience

  • Over 8 years in senior 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

 

Reporting line

  • S/he reports to GARDP Head of Clinical Affairs

 

Other information

  • Status: part time – temporary role – 6 months temporary position at 80%

 

To apply

  • Deadline for application: Accepting applications until 16 September 2018
  • Only shortlisted candidates will be contacted