Pharmaceutical Development Manager

Geneva, Switzerland
[Closing date: 6 February
2019]

 

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 has a large portfolio of R&D activities covering 7 disease areas: human African trypanosomiasis, leishmaniasis, Chagas disease, filarial diseases, mycetoma, paediatric HIV and hepatitis C. R&D projects are driven by patients’ medical needs for each disease area that in turn set strategy and scientific approaches.

DNDi does not have any research facilities and does not directly conduct research to develop its treatments. DNDi follows a virtual research model, whereby most research is outsourced with the R&D projects actively managed by DNDi personnel who are experienced in different aspects of pharmaceutical development.

DNDi proactively identifies research opportunities that have the highest potential to be translated into improved treatment options, then sources the research project into its portfolio, builds the full development plan, identifies and contracts the appropriate partners for each step in the development process, and manages the efficient advancement of the project throughout the pipeline.

Over half of the R&D staff are located in Geneva working in close collaboration with disease-specific R&D teams operating in regional offices located in Africa, Asia, and South America.

DNDi is seeking a Pharmaceutical Development Manager. Working with public and private sector partners, NGOs, and CSOs, Through R&D networks created based on South-South and North-South cooperation, DNDi aims to offer medical innovations taking into account the patients’ needs.

 

Purpose of the position

The Pharmaceutical Development Manager will play a critical role in the delivery of non-clinical safety studies and Chemistry, Manufacturing, and Control (CMC) activities for projects at all stages of R&D.

 

Specific job responsibilities

Manage non-clinical and CMC activities for assigned R&D projects

  • Establish strategies that meet project and regulatory requirements, in collaboration with the Head of Pharmaceutical Development and expert consultants
  • Develop and maintain suitable project schedules, budgets, and risk mitigation plans with project teams and external service providers
  • Liaise with service providers on a regular basis to monitor progress against milestones, as well as resolve technical, quality, or resource issues smoothly
  • Review and manage technical data and documentation to ensure timely action, compliant storage, and efficient retrieval
  • Prepare project updates, presentations, and reports for both internal and external stakeholders (e.g. DNDi Senior Management, Scientific Advisory Committee, donors)
  • Prepare regulatory documentation (non-clinical and quality modules) and support regulatory submissions
  • Develop and maintain project management skills and technical knowledge to oversee non-clinical and CMC activities effectively

General operational management of non-clinical and CMC service providers

  • In collaboration with the Procurement Officer, identify and evaluate potential external service providers, taking into account technical capabilities, quality requirements and cost-effectiveness
  • Organise quality agreements and audit schedules for service providers, monitor and improve their performance, and maintain a qualified service providers list
  • Maintain awareness of the contract research and manufacturing environment and relevant service offerings

Development and management of pharmaceutical quality systems

  • Support the development, implementation, maintenance and monitoring of quality systems for non-clinical safety studies and CMC activities to assure compliance with GLP, GMP, and GDP requirements
  • Manage DNDi standard operating procedures relating to pharmaceutical quality
  • Maintain awareness of applicable guidelines and regulations

 

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, applied preferably within a multi‑disciplinary R&D environment
  • 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

  • Strong knowledge of non-clinical safety studies, CMC activities, regulatory requirements, and their relationship to the drug development process
  • Strong ability to use spreadsheet and planning software

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
  • Degree in relevant scientific discipline (i.e. chemistry, pharmacy)

Other requirements

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

 

Reporting line

  • S/he reports to the Senior Pharmaceutical Development Manager

 

Resources managed

  • Responsible for managing non-clinical and CMC service providers to agreed timelines and financial targets

 

Interactions

  • S/he works with assigned project teams and Heads of Programmes to deliver new treatments for neglected diseases in the DNDi portfolio

 

Other information

  • Status: full time – permanent role 

 

To apply

  • Deadline for application: Accepting applications until 6 February 2019
  • Only shortlisted candidates will be contacted