Clinical Project Manager HIV/HCV

Geneva, Switzerland
[Closing date: 11
 March 2018]                                                                 

    

Established in 2003, the Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development (R&D) organization that develops new, improved, and affordable medicines for deadly neglected diseases that afflict millions of the world’s poorest people.

DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research and 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.

Since its inception, DNDi has developed seven new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, paediatric HIV with several new drug candidates in the R&D pipeline including two for sleeping sickness. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.

The HIV/HCV team aims to develop solid first-line “4-in-1” fixed-dose combinations using the World Health Organization (WHO) recommended treatment regimen for HIV positive infants and young children. To address Hepatitis C patients’ needs, the team’s objective is to develop an affordable public health tool using direct-acting antivirals (DAAs).

 

Purpose of the position

The Clinical Manager HIV/HCV, will play an important role in the development of new drugs and treatments for neglected diseases. S/he will be involved in the coordination, support and documentation of projects throughout all stages of the development process, with particular focus on the clinical phases. As a Clinical Manager, s/he will report to the Clinical Trials Leader in the DNDi HIV/HCV team.

 

Specific job responsibilities

Develop project plans

  • Develop project protocol, project schedules, and budgets within defined timelines with the clinical team and the investigators
  • Validate, drive, and monitor, with the trial team with the Clinical Trial Lead the key study milestones from launch of trial team to approved study results, propose, and implement contingency plans if the milestones are not reached
  • Ensure members of the trial team have established plans in place to deliver milestones on time
  • CTS, regulatory, safety, quality, legal, and external vendors
  • Review/approve principal implementation team deliverables: protocol, CRF, DMOP, statistical analysis plan, final clinical study report
  • Participate in the development an overall study budget with clinical trial lead and finance
  • Play a full role in the R&D team and to be an active member of the DNDi organization

Ensure regulatory compliance for projects

  • Ensure training of partners on pharmaceutical regulatory requirements, documentation, and processes for major international agencies
  • Ensure timely and appropriate training of all trial team members and Monitors
  • Ensure projects follow GCP, international, and local regulatory compliance and keep appropriate documentation
  • Supervise preparation regulatory documentation
  • Prepare and review clinical SOPs and other standard documents required for clinical trials, and compile list of SOPs used by different vendors
  • Contribute to set up and to review of DNDi systems related to clinical operations as appropriated
  • Ensure that targets set within the local quality management plan are met

Manage and develop project reporting systems

  • Collect data and information to enable Head of Disease area / and Clinical Trial Leads and the R&D Director to make effective and cost-efficient use of DNDi resources
  • Interact with study site teams on a regular basis to ensure that projects meet their milestones, proposes, and implements contingency plan if the milestones are not met
  • Provide logistical support and tracking for all trial materials with the trial monitors, trial managers, and site investigators
  • Liaise with the project consultants, vendors, and collaborators within the project network
  • Write a monthly project update, when requested

Responsible for study conduct

  • Drive the development of the protocol synopsis and protocol; coordinate the input of all content from other sources and drive the review/approval process
  • Identify external vendor requirements, and pursue appropriate vendor agreements, develop vendor specifications and secure contract
  • Initiate CRF design, input, review & approve
  • Drive investigator selection and contracting
  • Drive Investigator meeting preparation/conduct
  • Trigger the process for creation of the trial master file
  • Initiate drug order execution
  • Establish regular external and internal communications including monthly status reports, newsletters, implementation team meetings, project team meetings
  • Input review and approval of the DMOP
  • Provide input and review of the database set-up
  • Drives the implementation of the enrollment plan
  • Drives site management; plans and focuses all activities
  • Review SAP; reviews dry runs and inputs to resolve data issues
  • Data cleaning/query resolution – handle clinical and classification issues
  • Participate in results review
  • Initiate and ensure execution of the report writing process by securing resource commitment, establishing and validating timelines, identifying contributors and reviewers, input into content, drive review process (with medical writer), finalize safety narratives (with safety department)

Enable review of projects

  • Provide progress reports to the Paediatric HIV/ HCV Clinical Trial Leader 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

Personal

  • Develop and maintain the skills required for delivery of all aspects of clinical trials (risk based monitoring …)
  • Maintain an awareness of all developments in the designated neglected diseases that relate to drug development and disease control with initial self-education and mentoring by Head of Disease and Clinical Trial Lead
  • Be aware of developments in clinical development and the international, regional and local regulatory environment, and report these to DNDi

 

Job requirements

Skills and attributes

  • 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
  • Strong analytical skills
  • Strong ability to provide high level support in project/programme delivery
  • Strong ability to manage medium/large projects with budget management
  • Strategic thinking and leadership abilities
  • Strong management, negotiation, and advocacy skills
  • 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

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

Experience

  • Minimum 6 years’ relevant experience in which at least 4 years at Senior Officer level
  • 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
  • Willing to travel (40 to 50%) on the field of a 1 to 2 weeks’ duration, for site and co-monitoring visits

 

Reporting line

  • S/he reports to the Paediatric HIV/HCV Clinical Trial Leader

 

Interactions

  • Works with rest of the HIV/HCV team, and other transversal R&D units (Medical Affairs, Pharmaceutical Development)

 

Other information

  • Status: full time – permanent role  

 

To apply

  • Deadline for application: Accepting applications until 11 March 2018
  • Only shortlisted candidates will be contacted.