Associate Director, Access and Product Management

vor 4 Wochen

Geneve, Schweiz Medicines for Malaria Venture (MMV) Vollzeit

Medicines for Malaria Venture (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 two decades, MMV has worked with an extensive network of donors, private and public sector partners, experts and clinical centres in endemic countries to develop the largest existing portfolio of antimalarial projects.

Working with drug discovery/development partners in academia and industry, as well as with country-based delivery partners and national ministries of health/malaria control programmes, MMV’s focus extends from the identification of new potential treatments for malaria through to clinical development, regulatory approval and delivery-for-impact in malaria endemic countries.

We are currently seeking an Associate Director to join our Access and Product Management (APM) team, for a 3 year-assignment.

**The Associate Director will**:
1. Support the generation of real world evidence to inform national policy adoption processes
- Provide global leadership for operational feasibility studies and collaborate with consortium partners and national counterparts to ensure the implementation of feasibility studies in line with the approved protocols. The studies are designed to answer Ministry of Health (MOH) questions related to the implementation of optimized radical cure products in at least 5 countries: Peru, Ethiopia, Indonesia, Papua New Guinea (PNG), Vietnam.
- Collaborate with the consortium partners to finalize the master protocol for the feasibility studies in PNG and Indonesia. Support the WHO Research Ethics Review Committee (ERC) review process, including subsequent amendments, as appropriate.
- Lead Global Study Team and Protocol Writing Committee and provide technical oversight during all phases of the development and implementation of the studies, ensuring end-to-end planning, conduct and reporting of studies.
- Work in close collaboration with the MMV Chief Medical Officer (CMO) and with the Head of Quality Assurance, as well as with the Legal and Regulatory departments, to ensure that real-world studies are conducted in compliance with ethical principles and applicable research regulations.
- Liaise with Clinical Operational team members in MMV and consortium partners to ensure smooth study planning and execution.
- Oversee the work and deliverables of Global Trial Manager, Project Officer and consultants with technical expertise (statistician, procurement and supplies expert).
- Oversee and manage external vendors responsible for study supplies, data management and biostatistics services.
- Support MMV CMO and Global Medical Monitor in ensuring safety monitoring of studies and timely reporting of SAEs and AESIs.

2. Provide technical oversight and support of in-country activities
- Support the adaptation of the master protocol to finalize country-specific protocols and other documents. Collaborate with national PIs to support submissions of research protocols to national review processes and to develop subsequent amendments, as required.
- Support the development and approval of study protocol for a feasibility study in Vietnam.
- Support engagement with the Ministries of Health (MOH) / National Malaria Control Program (NMCP), regional stakeholders, WHO as required.
- Provide support to study country teams to ensure timely conduct of implementation studies throughout all stages (from study preparation to close-out).
- Ensure adequate quality systems are in place to ensure the integrity of data.
- Support national adoption and scale-up by collaborating on the development of training materials, pharmacovigilance activities and pharmaco-economics data, and sharing of relevant data.
- Ensure maintenance of appropriate document management systems by country teams.

3. Reporting and knowledge sharing
- Submit regular progress reports to MMV Director of Access.
- Provide study management oversight (review monthly report, country Gantts, risk logs, RACIs, recruitment rate)
- Review budgets, timelines, monitoring and evaluation (M&E) plan.
- Support the global and regional/country project teams (finance, external relations and access) in developing bi-annual reports to the donor, including progress against targets, timelines and other reports requested by the donor.
- Support the consolidation and publication of the evidence base on radical cure.
- Communicate issues identified in the countries and partner with internal MMV functional areas to develop corresponding mitigation strategies and recommended approaches.
- Develop supporting technical material for decision-making by program leadership
- Proactively share information across countries and regions.

4. Representation
- Represent MMV at conferences, international / regional / national meetings

**Education and e

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