Global Clinical Program Excellence Lead for

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**Global Clinical Program Excellence Lead for Neglected Tropical Diseases (all genders)**

The Global Clinical Program Excellence Lead (GCPEL) for Neglected Tropical Diseases (NTD) serves as the clinical development and operations lead for assigned Clinical Development Programs (CDP) focused on Neglected Tropical Diseases. These programs may encompass multi-asset and/or multi-indication portfolios across various Neglected Tropical Diseases. The GCPEL strategically plans and executes highly complex global drug development programs, emphasizing lean and efficient execution to maximize both, medical and commercial value. The GCPEL for NTD s collaborates with international partners, including NGOs, governmental agencies and academic institutions, to drive the program and the public health impact of the initiatives.

**YOUR TASKS AND RESPONSIBILITIES**
- Develops and drives the clinical program strategy for Clinical Development Plans (CDP) focused on NTDs, including Lifecycle Mgmt. (LCM) and continuous updates, as required to best support the pipeline execution strategy of the NTDs
- Oversees the planning, including development of scenarios, clinical development timelines and budgets managing them against the approved Clinical Development Plan (CDP) of the NTDs
- Establishes relationships and collaborates with internal and external stakeholders, including NGOs, governmental agencies, academic institutions, and public health organizations, to drive program success
- Communicates and provides insights and perspectives regarding NTDs and the NTD programs across internal and external stakeholders and partners
- Leads committed and engaged teams, models and shapes effective team behavior to achieve program goals of the NTDs
- Mentors, provides peer coaching, tactical advice and expertise within and outside of the team based on in-depth expertise of NTDs and the stakeholder landscape in NTDs
- Engages in peer-based performance review formats and provides actionable feedback across team members
- Oversees and coordinates submission activities at program level for NTDs, providing expert review and strategic input for regulatory and submission documents
- Proactively initiates and implements corrective actions and troubleshooting at program level based on operational and compound expertise in the indication, as needed
- Takes the lead in key strategic activities and complex, high priority expert working groups in the context of Neglected Tropical Diseases
- Demonstrates VACC leadership for internal and external teams

**WHO YOU ARE**
- Master’s degree in Life Sciences (in the area of NTDs is a plus) with several years of pharmaceutical industry experience in clinical development and operations; alternatively, equivalent length of Drug Development Project Management experience with focus on NTDs
- Proven track-record in delivering complex, key and high-priority clinical programs in the context of Neglected Tropical Diseases
- Thorough understanding of Neglected Tropical Diseases, including scientific understanding, research, development, epidemiology, and treatment strategies
- First-hand experience in working with and network in public health organizations, NGOs, academic institutions, and governmental agencies in the context of Neglected Tropical Diseases
- In-depth experience in drug development and of Good Clinical Practices (GCP), federal and international regulations and guidelines (e.g. International Committee for Harmonization (ICH) guidelines)
- Expert ability to integrate the complex cross-functional requirements into an operationally executable plan (including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters)
- Thorough understanding of the end-to-end drug development and commercialization process in the context of Neglected Tropical Diseases
- Demonstrated abilities to effectively navigate and resolve complex challenges, showcasing strong problem solving and negotiation skills and resilience in managing obstacles and uncertainties
- High energy with focus on outcomes; high sense of ownership, urgency, proactive and solution-oriented, and open-minded approach to new and creative ideas
- Collaborates with accountability and drives impactful decision making and results within virtual, multi-cultural and geographically diverse teams
- Effective written and verba