Acoziborole Industrial Liaison

vor 1 Woche

Genf, Genf, 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 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 include 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 Acoziborole Industrial Liaison plays a critical role in the delivery of Chemistry, Manufacturing and Control (CMC) activities for the development and registration of acoziborole, a new treatment for Human African Trypanosomiasis (HAT).
  • The role acts as the technical focal point for DND_i_ with its industrial partner and external Contract Development & Manufacturing Organisations (CDMOs).
  • The incumbent provides guidance and supervises CMC activities on acoziborole, including the work of other team members, CDMOs, independent consultants and advisors.
  • The role plays a major role in facilitating information flows and planning between DND_i_ and its collaborators.

Contribution

Scope of work (results)


The Acoziborole Industrial Liaison directly influences the quality of external technical activities and data, the compliance of CDMOs, the registration timelines and ultimately the approval of acoziborole.


Specific job responsibilities:

DND_i_
activities:

  • Develop CMC project plans, identify associated risks and establish mitigation strategies to support the advancement of acoziborole.
  • Maintain CMC risk register, develop and/or implement mitigation plans.
  • Resolve technical, quality or resource issues smoothly and escalate as needed.
  • Review and approve technical reports and GMP documentation, according to qualifications, training and experience.
  • Ensure compliance with DND_i_ Pharmaceutical Quality Policy and Pharmaceutical Development SOPs.
  • Share proactively and on a regular basis development progress with the industrial partner team and provide consolidated recommendations to discuss and agree on the appropriate actions to achieve project goals with a particular focus on submission readiness,

Lead external CMC activities:

  • Active oversight of CMC full development, manufacturing and regulatory activities at external CDMOs.
  • Project management of CDMO activities to ensure timely delivery of activities.
  • Management, curation and industrial partner review of all reports and documents required for CTD Module 3 and preapproval inspections.

Industrial partner activities:

  • Proactive and timely communication of issues or risks to the industrial partner that affect project strategy or submission timelines.

With the industrial partner CMC project leader:

  • Meet on a regular (weekly) basis to share progress and agree priorities.
  • Prepare agenda and content for joint CMC technical meetings.
  • Prepare presentations for project governance bodies (Global Project Team, Joint Development Committee and Joint Steering Committee).
  • Provide regular input to the industrial partner to build the project planning for CMC activities and attend the regular planning meetings organized by the GPM,
  • Represent DND_i_ CMC and ensure a close interaction with the industrial partner CMC PL, who acts as the industrial partner point of contact.

Regulatory CMC activities:

  • Active support of preapproval inspection readiness activities at DND_i_ and CDMOs.
  • Collaborate with the in

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