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Associate Director, Drug Development and Formulation

Location: Geneva, Switzerland

Medicines for Malaria Venture (MMV) was established in 1999 as a partnership between the public and private sector to discover, develop and deliver new antimalarial drugs at prices affordable to developing countries.

MMV is based in Geneva as an independent not-for-profit Swiss Foundation. It has an entrepreneurial modus operandi and has established a new business model through which it selects and manages its Research & Development portfolio.

MMV’s R&D portfolio is growing and we are looking for a talented person to join our evolving Translational Medicine team. In this role, the primary responsibility is to provide guidance on formulation development to our project teams. The Associate Director will also lead and manage multidisciplinary projects and ensure successful development of antimalarial drug candidates in partnerships with pharmaceutical/biotech companies and CROs.

The Associate Director will:

  • Supervise and guide formulation development for R&D projects including (list by no means exhaustive):
    • Identify suitably qualified experts in the field of formulation development who can advise on technical aspects of formulation development for clinical and pre-clinical studies, especially for fixed dose combinations
    • Identify & manage suitable CRO’s to carry out formulation development, ICH stability studies and clinical supplies manufacture MMV compounds
    • Monitor the progress, timelines and probability of success
    • Develop and agree requirements for formulations of MMV compounds to support preclinical and clinical studies
    • Define and agree bridging strategy and probability of success with regard to regulatory filing and approval
    • Lead discussions and decisions regarding the commercial manufacturing
  • Assume responsibility for drug development projects including:
    • Develop and manage project plans in collaboration with clinical development departments
    • Ensure that translational projects meet TPP requirements
    • Assist the Expert Scientific Advisory Committee (ESAC) in selection of development projects
    • Proactively create new partnerships developing new medicines
    • Review assessment reports to support candidate selection
    • Collect and provide information to support project progress to phase IIa
    • Ensure that investigational medicinal product (IMP) is manufactured to GMP specifications
    • Supervise and guide stability testing of active pharmaceutical ingredient (API) and finished IMP
    • Ensure that pre-clinical and clinical trials are conducted under GLP / GCP standards and are sufficient to achieve product registration
    • Evaluate and select CROs for conduct of pre-clinical and clinical activities
    • Control project budget and timeframe: negotiate and monitor partner contracts to provide cost effectiveness
    • Ensure all reports and data are obtained from partners in a timely manner
  • Perform miscellaneous job-related duties as assigned by management

Essential qualifications and skills:

  • PhD in Chemistry, Toxicology, Process Chemistry, Biochemistry or other related fields
  • Recent work experience in formulation development
  • Parasitology/infectious diseases background is an asset
  • Project management and leadership experience in pre-clinical and early clinical development; at least 5 years of experience that is directly related to the duties and responsibilities specified
  • Knowledge of FDA and EMA regulatory requirements, including ICH guidelines, and of regulatory framework (GMP, GCP and GLP)
  • Experience in overseeing manufacturing of investigational medicinal product (IMP)
  • Demonstrated ability to plan research activities to achieve project goals and objectives
  • Ability to provide technical advice, guidance and support to professional staff in area of specialty (formulation development)
  • Ability to develop and deliver both oral and written presentations at an international conference level
  • Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical and research environment; ability to communicate with opinion leaders
  • Clear and concise verbal and written communication skills and strong organizational skills
  • Must be detail oriented, have the ability to prioritize and handle multiple tasks simultaneously and the ability to work independently and in a team environment
  • Must be dedicated to quality and reliability in all work tasks
  • Must have self-motivation, eagerness to grow professionally and commitment to self-development
  • Proficiency with computers (PC-Windows based Microsoft programmes preferred)
  • Willingness to travel as necessary, consistent with the project needs
  • Spoken and written English, knowledge of French and other languages important

Interested applicants should send their CV and a covering letter giving reasons for their interest in the position to jobs@mmv.org before 4 December 2011. Please refer to the following job code in the subject line of your email: R&D-2011-6.