MMV is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs. Over the past 17 years, MMV has worked with an extensive network of donors, private and public sector partners, experts and clinical centres in endemic countries to develop an outstanding portfolio of antimalarial projects.
MMV is seeking an experienced professional to provide clinical science / clinical pharmacology expertise on cross-functional project teams to ensure efficient and effective clinical development of potential new antimalarials in MMV’s portfolio. The position is for a 3-year period.
In collaboration with the team, the Associate Director, Clinical Sciences will define clinical strategy, design clinical studies, and provide hands-on technical expertise including writing of key clinical documents, data analysis and interpretation.
Primary duties and responsibilities:
- Provide strategic clinical scientific input to projects in full development or post-approval phase
- In partnership with Medical and Regulatory experts at MMV, advise project teams on clinical development strategy in order to best deliver the target product profile, in alignment with MMV’s overarching antimalarial drug development strategy
- Represent MMV’s position when working with partners to develop aligned recommendations, and to support Project Directors to deliver on the overall project strategy and plans
- Contribute to the development of clinical trial documents as required including clinical study protocols, investigator brochures and other regulatory documents
- Perform ongoing review of clinical data, statistical analysis plans and interpretation of clinical results, and produce integrated summaries and clinical development plans
- Provide incisive analysis and risk assessment of emerging data, anticipating and managing challenges, and identifying any need for changes to strategic direction
- Present information internally and externally, to a broad spectrum of stakeholders
- Work closely with clinical operations during study set-up, conduct and close-out activities, and act as an expert in clinical sciences to study sites
Education and Experience:
- PhD in the field of clinical pharmacology or biochemistry, pharmD
- Minimum 6 years’ experience in a medium to large pharmaceutical/biotech company within clinical development, clinical pharmacology and /or clinical sciences in late-stage drug development (preferably including phase IV)
- Experience within cross-functional development teams, resulting in broad understanding of the multi-disciplinary aspects of drug development
- Knowledge of drug combination development, paediatric development and/or infectious diseases is an advantage
Technical skills required:
- Full professional proficiency in English (oral and written); French and/or Portuguese is an asset
- Good knowledge of ICH Good Clinical Practice standards
- Knowledge of stringent regulatory authorities filling requirements (e.g. FDA, EMA)
- Excellent knowledge of clinical pharmacology and clinical drug development
- Good technical writing skills
- Familiar with the principles of statistics and pharmacokinetic and pharmacodynamics modelling
- Proficiency with Windows Office software
Behavioural skills required:
- Strong communication skills, verbal and written
- Results focused; with good project management, multi-tasking and organisational skills
- Demonstrated flexibility, dedication, and follow through to project completion
- Leadership, collaboration and interpersonal skills: ability to work with teams across hierarchy and cultures with tact and diplomacy
- Ability to work independently in a matrix environment
- Willingness to travel, including to malaria-endemic countries (20%)
Start date: 1 February, 2018
Interested applicants should send their CV and a cover letter giving reasons for their interest in the position to jobs [at] mmv.org before 7 January 2018. Please refer to the following code in the subject line of your email: RD-2017-22.
Recruitment agencies are kindly requested to refrain from submitting applications.