MMV Severe Malaria Consortium Intrarectal Astesunate (lr AS) Prequalification Project Manager Job in Kenya

MMV Severe Malaria Consortium – Intrarectal Astesunate (lr AS) Prequalification Project Manager

This is a consultancy position, not an MMV staff position.

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 and its consortium partners have been awarded a three-year grant by UNITAID for the implementation of a project entitled “Improving Severe Malaria Outcomes”, with the objective of securing the prequalification pathway for prequalification of Ir AS along with the development of a GMP commercial-scale manufacturing solution.

MMV is seeking a contract Project Manager for this three-year project.

This position will work closely with potential manufacturers of Ir AS and WHO prequalification to ensure the goals, outputs and activities of the project are being achieved within the planned timelines.

This will involve travel between the manufacturer(s) to achieve these goals. This position will report to MMV’s Head of Translational Medicine.

We are seeking a highly motivated individual with outstanding credentials, analytical ability, and communication skills.

The candidate must be able to function independently and should have a proven track record of excellence in pharmaceutical project management.

The Project Manager will:

• Provide analytical and technical support to MMV in ensuring prequalification of at least one manufacturer of artesunate suppositories.
• On behalf of MMV, monitor timely progress and completion of key deliverables.
• Manage the dossier transfer from WHO TDR and review existing Phase III clinical data and manufacturing master files. Identify industrial partner(s) for Ir AS manufacturing solution.
• Guide industrial partner(s) in conducting the Stability Testing of intrarectal artesunate formulations to ensure that the product will meet the TPP.
• Provide technical assistance to industrial partner(s) to prepare for WHO PQ GMP inspection. Provide assistance to industrial partner(s) in preparation and during the submission of PQ dossier.
• Plan and execute with industrial partner(s) the clinical studies required by WHO PQ to establish relative bioavailability of a rectal formulation of artesunate.
• Manage the budget allocated to the project.
• Assist the MMV Finance and Access Teams in developing bi-annual reports for the donor, including progress against log frame targets.
• Disseminate information from MMV and partners at Advisory group meetings.

Essential qualifications and skills:

• Life science degree
• 5-7 years of relevant work experience in the field or in pharmaceutical /healthcare industry
• Excellent written and oral communication skills
• Strong report-writing skills, particularly with regards to donor reporting requirements
• Strong problem solving skills and analytical capabilities
• Detail-oriented with strong organization skills
• Ability to handle multiple tasks simultaneously, set priorities, and work independently
• Ability to be effective in high-pressure situations and work in a fast-paced, limited-structure, -multicultural environment

Added Assets:

• Experience in management of pharmaceutical industry development projects
• Experience in interaction with regulatory agencies and/or WHO prequalification
• Planning and execution of bioequivalence/relative bioavailability studies

How to apply:

Interested applicants should send their CV and a covering letter giving reasons for their interest in the position to jobs@mmv.org before 10 June 2013. Please refer to the following code in the subject line of your email: A&PM-2013-4