Associate Director, Drug Development, CMC and Analytical Chemistry

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 expertise to our translational and development projects on scale up synthesis of candidate compounds, advice on the analytical method development, review the specifications of batches and consult with the project team on suitability of batches for the use in pre-clinical and clinical studies. 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:

• Provide regulatory expertise related to all active pharmaceutical ingredients (API) and investigational medicinal product (IMP) related questions
• Supervise and guide Chemistry, Manufacturing and Control (CMC) activities for our R&D projects:
  • Identify & manage suitable CRO’s to develop both enabling and ultimate commercial synthetic route, manufacturing process development and manufacture API batches, (or to source commercially if applicable) and to monitor progress and timelines
  • Define overall API enabling and commercial route development, supply and batch strategy in order to align level of development activity and cost vs. stage of development and attrition risk
  • Polymorph formation and selection
  • Salt selection
  • Analytical method development
  • Ensure that API batches are suitably qualified for clinical or pre-clinical use as required
  • Assess suitability of batches for the use in pre-clinical and clinical activities:
    • Review purity of non-GMP and GMP batches
    • Assess whether impurities and degradants (both API and drug product related degradants) are qualified prior to administration to human
    • Level of potential genotoxic impurities
    • Assess other impurities and impact on preclinical and clinical activities
    • 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 IMP is manufactured to GMP specifications
      • Supervise and guide stability testing of API and finished IMP
      • Ensure that pre-clinical studies 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
      • Controls 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

Essential qualifications and skills

• PhD in Chemistry, Toxicology, Pharmacy, Biochemistry or other related fields
• Recent work experience in formulation development, toxicology
• Parasitology/infectious diseases background is an asset
• Qualified Person (QP) qualification 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; detailed knowledge of regulatory framework (especially GMP)
• 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 (CMC and analytical chemistry)
• 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
• 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-2011-7