Clinical Trial Laboratory Manager – Microbiology 50%

South Africa: Cape Town or Johannesburg
[Closing date: 15 April
 2018]                                                                 

 

The Drugs for Neglected Diseases initiative (DNDi), established in 2003 in Geneva, Switzerland, is a collaborative, patient-needs driven, non-profit drug research and development (R&D) organization that seeks to improve the quality of life and the health of people suffering from neglected diseases by using an alternative model to develop drugs for these diseases and by ensuring equitable access to new and field-relevant health tools.

DNDi is now working across 10 offices (Geneva, Rio, Kinshasa, Nairobi, New Delhi and Patna (India), Kuala-Lumpur (Malaysia), New York, Tokyo and most recently Cape Town) employing ~200 full time equivalent core staff and operating through a virtual business model with many partners, suppliers and consultants. As part of its mission, DNDi advocates for increased public responsibility and a more enabling environment for neglected disease R&D at a global, regional and national level.

Since 2014, DNDi has initiated activities in South Africa, mainly with its currently ongoing Paediatric HIV programme and the extension of the ongoing HCV programme with clinical studies starting in South Africa in 2018.  A Memorandum of Understanding was signed in 2014 with the South African Department of Health for the Paediatric HIV programme. 

More recently, WHO and the DNDi have collaborated on the creation of a Global Antibiotic Research and Development Partnership, to develop new antibiotic treatments addressing antimicrobial resistance. 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 as such is part of the DNDi institutional framework for the incubation period.

GARDP signed a Memorandum of Understanding in 2016 with the South African Medical Research Council to establish the basis for close collaboration both institutionally and on specific projects including on drug development for neonates, sexually transmitted diseases, and drug discovery. GARDP launched two projects in 2017 and anticipate two additional projects in 2018, with drug discovery and substantial clinical activity in South Africa.

DNDi, and in particular the GARDP and the HIV/HCV programmes, aims to strengthen its presence in South Africa, and has established a Liaison office in Cape Town, hosted initially within the South African Medical Research Council, to support the R&D activities, manage the relationships with academia, pharmaceutical companies, and government agencies.

 

Purpose of the position

GARDP – STI Programme

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 800’000 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. Currently, the WHO-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.

The Clinical Trial Laboratory Manager (CTLM) plays a central role in the planning and conduct of GARDP-sponsored clinical trials. He/she leads the laboratory component of all trials and ensures compliance with relevant quality standards. The post is based in South Africa and occasional travels to Europe, US, Thailand, and Brazil are expected.

 

 

Specific job responsibilities

Responsibilities

  • Lead the laboratory components of the GARDP Clinical Trials, both on an individual trial basis and across clinical trials, thereby standardizing the laboratory requirements where possible
  • Assess and select partner labs/ sub-contractors for the provision of clinical laboratory services to trial sites
  • Ensure strict adherence to Good Clinical Laboratory Practice (GCLP) and other laboratory quality standards throughout the trial laboratory services providers, and when necessary, support the strengthening of partner laboratories to meet these standards
  • Provide ongoing training, advice, and technical supervision to partner laboratories

Main tasks

The Clinical Trial Laboratory Coordinator assumes overall responsibility for the lab functioning of the GARDP-sponsored trials on a global basis, the success of the trial being heavily dependent on the quality and robustness of microbiological outcomes. S/he will work closely with the GARDP programme teams, the programme partners (e.g. the WHO Gonococcal Antibiotics Surveillance Programme (GASP)), and the national microbiology laboratories in South Africa, Thailand, Brazil, and USA.

Main tasks include
  • Ensuring that the trial design is feasible and appropriate from a laboratory perspective, in collaboration with internal and external experts, and contribute to the development of the trial protocol
  • Manage the laboratory component of the clinical trials, including the writing of the Laboratory Manuals (laboratory and investigational sites) standardizing the laboratory procedural requirements within the trial and across laboratories.
  • Lead the development and implementation of the laboratory strategy and work plan, and ensure the lab component is implemented in compliance with GCLP and other laboratory standards set by the US-FDA
  • Set up a network of partner microbiology laboratories and support them in developing appropriate quality assurance and quality control systems for all trial-related activities
  • In coordination with the CRO, monitor compliance of the partner microbiology laboratories with GCLP and other relevant laboratory quality standards, and ensure the partner delivers microbiological data that meets US-FDA requirements
  • Ensure technical support to partner microbiology laboratories and provide mentoring, training, and supervision of lab personnel based in trial countries
  • Set-up, organize, and monitor specimen and isolates handling, storage, and transport to the reference laboratory responsible for central Antibiotic Susceptibility Testing
  • Manage laboratory contracts including development of TORs, review budget and expenditures, and ensure quality laboratory equipment and supplies are procured

 

Job requirements

Skills and attributes

  • Demonstrable (virtual) team-working skills as well as ability to work independently
  • Excellent communication and interpersonal skills
  • Strong 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
  • Strong communication skills in multicultural, multi-lingual environments
  • Strong ability to work effectively as part of a multicultural team
  • Well organized and structured
  • Has autonomy for taking actions and decisions
  • Strong ability to interact with external stakeholders

R&D technical skills

  • Knowledge of GCLP and other laboratory quality standards relevant to clinical trials
  • Knowledge and experience in STI laboratory diagnostic procedures including culture and molecular testing is a plus
  • Knowledge and experience in HIV laboratory diagnostic procedures including rapid tests, CD4 count, and viral load is a plus

Experience

  • Minimum 5 years relevant experience
  • Advance experience in working in microbiological laboratories
  • Experience and affinity with training and coaching
  • Experience working in low/middle income context programmes
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of managing external partners

Education

  • Degree in Microbiology or the equivalent

Other requirements

  • Fluency in written and verbal English
  • Position based in South Africa
  • Ability to travel frequently domestically and internationally (Asia, Latin America, and the US)

 

Reporting line

  • S/he has double reporting line to the Head of the South African Regional Office and to the Trial Manager of the respective GARDP programme

 

Other information

  • Status: part time 50 % – 2 years fixed term contract

 

To apply

  • Deadline for application: Accepting applications until 15 April 2018
  • Only shortlisted candidates will be contacted.