Director of Leishmaniasis Disease Programs

Há 11 horas

Rio de Janeiro, Rio de Janeiro, Brasil beBeeDisease Tempo inteiro R$90.000 - R$120.000
Program Director for Cutaneous Leishmaniasis

We are seeking a seasoned professional to lead our Cutaneous Leishmaniasis program. The successful candidate will have a strong background in disease strategy, clinical development, and project management.

Key Responsibilities:
  • Strategic Leadership: Develop and implement a comprehensive disease strategy for Cutaneous Leishmaniasis, working closely with stakeholders across the globe.
  • Program Oversight: Oversee the clinical development process, ensuring rigorous scientific and operational standards are met.
  • Product Development: Contribute to the strategic development of Leishmaniasis products, focusing on both Visceral and Cutaneous forms of the disease.
  • Initiatives Identification: Collaborate with Clinical Trial Managers, Regional Offices, and other units to identify key initiatives that form a robust disease strategy.

The Program Director plays a pivotal role in shaping the disease program's strategic direction. They will be responsible for developing and implementing the Clinical Development Plan (CDP), overseeing study activities throughout the clinical stages, globally and regionally.

Accountability and Compliance:
  • Ensure compliance with local, regional, and international regulatory requirements.
  • Sponsor trials, including organization and management of all trials.
Protocol Development and Submission:
  • Oversee the development of Clinical Trial Protocol Synopses, Clinical Trial Protocols, and any protocol amendments.
  • Submit Clinical Trial Protocol Synopses to the Scientific Advisory Committee (SAC) after review and approval by the Protocol Review Committee.
Data and Safety Monitoring Board (DSMB):
  • Validate DSMB composition and documentation in partnership with the Medical Director/Drug Safety Committee.
  • Review and validate major recommendations made by the DSMB and make recommendations to SIRC.
Project Management:
  • Manage and supervise R&D projects, including regulatory consistency and team supervision.
  • Organize regular project reviews and team meetings, inviting DNDi members as appropriate.
Communication and Representation:
  • Develop and maintain partnerships and networks, representing DNDI as a credible voice in the program area.
  • Enhance DNDi reputation through scientific publications and presentations at various levels.

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