Clinical Trial Leader HIV

Geneva, Switzerland
[Closing date: 19 October
 2018]                                                     

 

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.

DNDi began working on HIV in 2012 and on HCV in 2015, and the two programmes were grouped together in the HIV/HCV initiative in 2018. In HIV, DNDi aims to develop a new fixed-dose combination for HIV-positive infants and young children to replace existing treatment options that are unpalatable and highly unsuitable for use in resource-limited settings. In HCV, DNDi seeks to foster a public health approach to the disease and expand access to highly effective direct-acting antivirals, including by developing a simple and affordable treatment combination that can be used for all strains of HCV. The HIV/HCV team is primarily based in Geneva, with growing numbers of team members, consultants, and partners based in South-East Asia, East Africa, Southern Africa, South Asia, Latin America, and Eastern Europe.

 

Purpose of the position

The Clinical Trial leader for HIV plays a leading role in the Clinical development of new drugs and treatments for the disease. S/he will be involved in the supervision, development and regulatory review of clinical trial projects in Africa for HIV. S/he will ensure the smooth running of Clinical Trials, according to Good Clinical Practice and other ICH Guidelines. S/he will maintain and generate documentation pertaining to the management of the trial and will manage partners and Clinical Research Organizations to insure the above goals are obtained. As a Clinical Team Leader s/he will be expected to maintain frequent interaction with investigators, partners, and project team and to directly oversee the DNDi budget for his/her given studies.

 

Specific job responsibilities

Coordinate all clinical trial related activities

  • Guarantee the respect of the rights, safety, and protection of the persons participating in the clinical trial
  • Guarantee the respect of the applicable regulations and recommendations, and the Clinical Trial Protocol
  • Ensure accuracy, veracity, completeness, consistency with the source data collected
  • Ensure compliance with the objectives, the planning, the timelines, and the clinical trial budget
  • Supervise Clinical Trial Managers based in Africa
  • Work closely with the Team Leader on overall programme planning and budgeting

Project management

  • Planning, set-up, and follow-up of the clinical trials
  • Follow-up of the clinical trial progress: monitor milestones, compliance with the deadlines, presentation meetings of the clinical trial progress to the project team
  • Selection and 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
  • Support the Head of Clinical Development in the development of project plans and budget plans
  • Provide progress reports to Head of Clinical Development on individual projects including budget updates on a regular basis

Clinical trial documentation

  • 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, etc.
  • Coordination of the clinical trial documentation

DSMB (set-up phase and proceedings)

  • Evaluate directly or by oversight of CTM the need or not for a DSMB (Data Safety Monitoring Board) with the validation of the Direct Manager and the Medical Director, document the decision, and propose the DSMB chairperson and ether DSMB members
  • Define directly or by oversight of CTM the DSMB operating procedure (detailed in the DSMB charter) ensuring proper DSMB development, signature, filing approval as defined in this SOP together with the CTM
  • Ensure submissions to Ethics Committees (EC)/Institutional Review Boards (IRB) or Regulatory Authorities (RA) of DSMB related information if required as per local regulations (DSMB charter directly or by oversight of CTM)
  • Possibly attend open session of DSMB meeting, as described and agreed by all parties in the DSMB charter
  • Ensure DSMB procedures are followed, including recommendations distributions and DSMB documentation filing as defined in this SOP directly or by oversight of the CTM

Clinical trial set-up

  • Together with the Head of Clinical Development, define the study specific requirements for conducting a specified clinical trial
  • Define the requirements that the potential trial site must have for conducting a clinical trial and select the site with the support of CTM
  • Management of the clinical trial set-up:
    • 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 development plan & clinical trial protocol

  • Participate in the Clinical Development Plan Team
  • ls a mandatory member of the CDP Teams Reviews
  • Is in charge, directly or through oversight of the CTM, of the development of the clinical trial protocol synopsis, the clinical trial protocol for validation by the Director of the HIV/HCV Initiative prior to submission to the Medical Director
  • Work on the Master Informed Consent (MICF) documents as well as any updates
  • Participate to the CSR (Clinical Study Report) kick-off meeting
  • Support the clinical data management activities associated with the conduct of clinical trials pertaining to his/her programme
  • Ensure that safety and quality standards are integrated in planning
  • Ensure regulatory compliance in planning

Monitoring (set-up phase)

  • Designate or oversee the designation by the CTM an author for the monitoring plan, determine content contributors and designate reviewers of the monitoring plan and update and approve the monitoring plan as required
  • Ensure, directly or by CTM oversight that the appropriate members (e.g. Monitors) have been trained before the first monitoring visit occurs
  • Ensure, directly or by CTM oversight collaborative support from Data Management, PV and other functions as required, to develop the trial specify documentation needed for the trial, and inform the Procurement function, when applicable

Oversight of the clinical trial follow-up and clinical trial report

  • Follow-up, directly or by oversight of CTM of the trial allocated budget
  • Liaison with the CTM or the CRAs (when no CTM in place) for appropriate site monitoring
  • Coordination, directly or by oversight of the CTM of the clinical trial logistics (sending, return, destruction of the study supplies)
  • Management, directly or through CTM, 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 directly or through CTM of the Serious Adverse Events and other safety issues during the clinical trial
  • Follow-up, directly or through CTM 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
  • Oversight of the maintenance of the clinical trial documentation

 

Job requirements

Skills and attributes

  • High 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
  • Excellent communication, and public speaking skills, ability to convince and represent DNDi at high level events
  • Knowledge of managing global multicultural teams
  • Highly organized and structured
  • High analytical skills
  • High ability to lead large strategic projects
  • High ability to manage large size projects with budget management
  • Very strong strategic thinking and leadership abilities
  • Excellent management, negotiation, and advocacy skills
  • High ability to exercise high degree of independence to ensure programme delivery and explore new areas of activities
  • High ability to interact with internal and external stakeholders
  • High ability to lead and motivate a team for optimum performance

R&D technical skills

  • Excellent knowledge of Drug Discovery/Development
  • Excellent knowledge of Clinical Research/Development
  • Excellent knowledge of Regulatory (GCP, GLP and GMP)
  • Excellent knowledge of disease/academia knowledge
  • Excellent technical writing skills (procedures, protocols and reports)

Experience

  • Over 10 years in Senior role in conducting Clinical Trial and Clinical Operations
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of working in public and private sector is highly desirable

Education

  • Medical Degree or Paramedical, Pharmacist
  • Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level would be an advantage

Other requirements

  • Fluency in English
  • Proficiency in local languages desirable
  • Excellent knowledge of Microsoft Suite

 

Reporting line

  • S/he reports the Head of Clinical Development of the HIV/HCV Initiative
  • S/he supervises one or several Clinical Team Managers

 

Other information

  • Status: full time – permanent role

 

To apply

  • Deadline for application: Accepting applications until 19 October 2018
  • Only shortlisted candidates will be contacted