Senior Clinical Project Manager

Kuala Lumpur, Malaysia
[Closing date: December 31, 2017]
                                                                 

    

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)

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.

DNDi was established in Malaysia in 2004 based in Penang, working closely with the University Sains-Malaysia. With the shift in focus of regional activities to hepatitis C, the DNDi office was moved to Kuala Lumpur.

In this context of increasing activities and regionalization, DNDi has engaged a reorganization process which aims at effectively implementing the recently approved business plan, and has decided to create the new position of Senior Clinical Project Manager.

 

Purpose of the position

The Clinical Project Manager 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 Project Manager, s/he will report to the HIV/HCV Clinical Trial Leader in the DNDi Geneva based R&D team and to the Head of DNDi South East Asia; and to directly oversee the use of DNDi resources for given projects.

 

Contribution

S/he is accountable for managing projects, or delivering quality output through expert services or people. S/he adapts policies, approaches, and models to emerging needs and defines practice and procedures/guidelines. He/she is accountable of delivery of a complex project within established framework.

 

Specific job responsibilities

Develop project plans

  • To develop project protocol, project schedules, and budgets with the clinical team and the investigators
  • To monitor milestones for project evaluation with the Clinical Trial Leader
  • To play a full role in the R&D team and to be an active member of the DNDi organization
  • To implement collaborative partnership programs with third party organizations such as FIND and MSF

Ensure regulatory compliance for projects

  • To ensure training of partners on pharmaceutical regulatory requirements, documentation, and processes for major international agencies
  • To ensure projects follow GCP and regulatory compliance and keep appropriate documentation
  • To participate in preparing regulatory documentation
  • To prepare and review clinical SOPs and other standard documents required for clinical trials
  • To contribute to set up and to review of DNDi systems related to clinical operations as appropriated
  • To ensure that targets set within the local and regional quality management plan are met

Manage and develop project reporting systems

  • To collect data and information to enable Head of disease area, Head of DNDi SEA, clinical trial leads, and the R&D Director to make effective and cost-efficient use of DNDi resources
  • To interact with study site teams on a regular basis to ensure that projects meet their milestones
  • To provide logistical support and tracking for all trial materials with the trial monitors, trial managers, and site investigators
  • To liaise with the project consultants and collaborators within the project network
  • To write a monthly project update, when requested

Enable review of projects

  • To 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
  • To assist in the preparation of materials for presentation to the Scientific Advisory Committee (SAC) and other interim and formal reviews

Personal

  • To develop and maintain the skills required for delivery of all aspects of clinical trials
  • To maintain an awareness of all developments in the designated neglected diseases that relate to drug development and disease control
  • To be aware of developments in clinical development and the regulatory environment in the SEA region, and report these to DNDi
  • To actively contribute to a collaborative, open and inclusive working environment with DNDi colleagues and project stakeholders

Additional/ specific/ projects responsibilities

  • When required, needs to network with local Authorities and other stakeholders to support the full project including advocacy and access component in collaboration with the Head of DNDi SAE

Reporting line

  • S/he reports to HIV /HCV Clinical Trial Leader and regionally to the Head of DNDi SAE

 

Job requirements

Skills and attributes

  • Very strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
  • Very strong ability to manage large size projects with budget management
  • 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
  • Strong strategic thinking and leadership abilities
  • Very strong management, negotiation, and advocacy skills
  • Very strong ability to represent DNDi core vision and mission
  • 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

  • Excellent knowledge of Clinical Research/Development
  • Excellent knowledge of Regulatory (GCP, GLP and GMP) preferably in South East Asia
  • Good knowledge of HCV disease
  • Excellent Technical writing skills (procedures, protocols and reports)

Experience

  • Over 5 years in Senior role in project management is mandatory
  • 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. Medical doctor a plus

Other requirements

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

Other information

  • Status: (Full time – Permanent role) 

 

To apply

  • Deadline for application: Accepting applications until December 31st, 2017
  • Only shortlisted candidates will be contacted.