Pharmaceutical Development Leader

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Geneve, Schweiz Drugs for Neglected Diseases Initiative Vollzeit

The Drugs for Neglected Diseases _initiative _(DND_i_) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases affecting millions of the world’s poorest people.

Together with more than 200 public research and industry allies worldwide, we use the power of partnership, innovation, open science, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people. Driven by collaboration, not competition, and by patients’ needs, not profits, we promote equitable access, foster inclusive and sustainable solutions, and advocate for a more effective global biomedical R&D system that meets the needs of neglected patients.

Since our inception, DND_i_ has delivered 12 new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, hepatitis C, and malaria that have saved millions of lives. We now aim to deliver an additional 11-14 new treatments by 2028 - addressing R&D gaps for neglected tropical diseases and viral infections, including new pandemic-prone diseases (such as Covid-19) and climate-sensitive diseases (such as dengue) with a focus on the needs of patients in low
- and middle-income countries.

The R&D organization includes three clusters of Diseases expert teams: NTD/Mycetoma and Leishmaniasis, NTD/Chagas-Filarial-HAT and Viral Diseases. Medical Affairs (Pharmacovigilance, Clinical Quality and Assurance, Regulatory and Translational Sciences), Global Clinical Operations, R&D Portfolio and Planning, Discovery and Pharmaceutical Development teams complement the R&D expertise. Projects review, Science and strategy is managed by the Scientific Internal Review Committee (SIRC); The R&D Coordination team lead the R&D organization for all other topics.

**Purpose of the position**:
The Pharmaceutical Development Leader plays a critical role in the delivery of Chemistry, Manufacturing and Control (CMC) and supply activities for projects at all stages of R&D.

The role supports and deputises for the Pharmaceutical Development Director to advance the pharmaceutical development activities across the disease areas and ensure adequate resourcing of the different projects.

The position leads CMC activities for large scale projects, including strategy, budget and timelines in close collaboration with DND_i_’s translational and disease teams and external partners.

This role provides guidance and supervises CMC activities on multiple projects, including the work of other team members, external contract development and manufacturing organisations, and external consultants and advisors.

The incumbent is responsible for the evaluation and selection of appropriate API and drug delivery technologies to meet the needs of the project at different stages of development.

The role contributes to the development and management of pharmaceutical quality systems to ensure compliance with GLP, GMP and GDP requirements, and implements new ideas and tools for managing these efficiently.

**Contribution**

The Pharmaceutical Development Leader turns the strategic intent into operational reality through the design, development and implementation of programme/projects or the provision of services to the entire organisation. Plans, integrates and coordinates work to deliver a comprehensive programme or a service platform and manage operational aspects of the delivery. Develops new approaches, techniques or policies and establishes important guidelines. Proposes strategic direction, staffing and budget decisions to her direct supervisor.

**Scope of work (results)**

The Pharmaceutical Development Leader role affects delivery of a programme/projects and success of the team and directly impacts on the output of DND_i_ in the short to medium terms. Information disseminated to external communities affects the image of DND_i_, impacting on the commitment of stakeholders and resource mobilisation.

**Specific job responsibilities**:
**Lead CMC effort for projects at all stages of development**:

- Deputise for the Pharmaceutical Development Director, notably by contributing to key internal and external meetings and through the approval of quality and regulatory documents.
- Establish pharmaceutical development strategies that meet both project and regulatory requirements and set individual strategic goals accordingly, including the evaluation and selection of suitable API and drug delivery technologies.
- Act as pharmaceutical development point of contact and active member of joint development committees with industrial partners.
- Act as a project leader for discrete projects within the DND_i_ portfolio.
- Review and approve regulatory documentation (non-clinical and quality modules) and support regulatory submissions and associated interactions with regulatory authorities.
- Develop CMC project plans, identify associat

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