GAP-f Clinical Research Senior Consultant

GAP-f Clinical Research Senior Consultant

Penta Foundation - Child Health Research

Padova - 6 ore fa

Background

The Global Accelerator for Paediatric Formulations (GAP-f) is a WHO (World Health Organization) Network launched in 2020 to address the Paediatric medicines gap. It is a network of 33 organizations that works across the life cycle of drug development by bringing efficiency through enhanced coordination across stakeholders to prioritize, evaluate, develop and deliver better Paediatric medicines.

As part of the Network, Penta foundation is leading the GAP-f Clinical Research Working Group and is an active contributor to the overarching programme discussions. The Clinical Research Working Group surveys the landscape of studies related to the GAP-f portfolio and facilitates the design and implementation of missing high-quality clinical studies to inform the dosing, safety, and efficacy of new medicines for children.

GAP-f is led by a Secretariat, which is responsible for developing and maintaining the GAP-f strategy, leading GAP-f’s advocacy work, and overall operations of GAP-f. The Secretariat sits within WHO’s Research of Health (RFH) Department in the Science Division and has a coordination function, liaising with 33 external organizations as well as multiple technical departments within WHO. The GAP-f Secretariat supports the work of four working groups which are designed to gather GAP-f network members and leverage their expertise to address systemic barriers across the product life cycle. The working groups include portfolio prioritization, clinical research, product development and regulatory affairs, and access and delivery.

As GAP-f enters its 2025–2030 strategic phase, it will focus on strengthening the paediatric clinical trial ecosystem and helping countries leverage real-world evidence to monitor the safety and effectiveness of novel medicines. These priorities align with the World Health Assembly (WHA) resolution 75.8 on strengthening clinical trials, which calls for high-quality, ethical, and globally coordinated research to address gaps in clinical trials with a focus on underserved populations such as children. To support these efforts, GAP-f will track clinical trial progress, identify bottlenecks, and advocate for streamlined regulatory pathways to accelerate access to new treatments. It will also facilitate stakeholder collaboration through regulatory and industry dialogues, optimizing study design, clinical trial initiation, and innovative methodologies for data generation. Additionally, GAP-f will expand clinical research capacity by mapping trial infrastructure, integrating networks, and leveraging regional collaborations, particularly in Southeast Asia, to accelerate paediatric medicine development.

A key priority for GAP-f for the next three years is strengthening the paediatric medicines ecosystem in Asia. This includes developing a roadmap for establishing a national paediatric data hub to monitor the safety and effectiveness of priority medicines. To achieve these objectives, GAP-f will work closely with global and regional partners and stakeholders to contribute to the broader clinical trial ecosystem agenda and support regional leadership in clinical research.

To this end, the incumbent will support the GAP-f Secretariat in advancing the clinical research ecosystem strengthening and piloting a paediatric data and knowledge hub in four selected ASEAN countries.

Location

Flexible (preferred timezone between GMT and GMT-7)

Job Duties

1. Leverage GAP-f network towards strengthening clinical research ecosystem for investigation of novel medicines and formulations in children
   • Lead and coordinate the activities on mapping, assessing and connecting clinical trial sites across the partnership that can deliver high quality clinical trials to inform approval and optimal use of novel medicines and formulations in children.
   • Coordinate the exploration of innovative trial designs in collaboration with GAP-f partners to overcome current bottlenecks related to investigation of novel solutions in areas such as neonatal sepsis, novel TB medicines and neglected tropical disease.
   • Create a repository with material and expertise to deliver a capacity strengthening for clinical trial conduct event at regional level (specific regions to be decided).
   • Contribute to ad hoc regulatory and industry engagements to optimize study design and implementation to optimize evidence generation for priority diseases.
   • Engage and synergize with core activities led by the Clinical Trials Forum.
2. Pilot data and knowledge hub for paediatric medicines in 4 selected ASEAN countries
   • Lead and coordinate the activities on mapping national data sources and develop a roadmap for the set-up of a national paediatric data hub for the safety and monitoring of priority paediatric medicines.
   • Coordinate the identification of case studies to test data harmonization, sharing and analysis.
   • Design a plan for implementation of a national paediatric data hub including steps to standardize, organize and store data securely.
   • Coordinate partners in the exploratory analysis to monitor safety and effectiveness of priority paediatric medicines.
   • Support regional capacity building efforts such as training healthcare workers in data collection, input and analysis led by national and regional counterparts.
3. Provide technical support to the GAP-f Clinical Research Working Group. This will include:
   • Develop clinical research working group objectives and facilitate development of its work plan, in line with GAP-f phase 3 strategy.
   • Plan and coordinate ad hoc meetings and webinars.
   • Contribute to engagement with industry & regulators to optimize formulation clinical development.

Anticipated deliverables would include:

• Web interface and repository to map clinical trial sites equipped to enroll and deliver high quality paeds research to inform approval and use of novel medicines.
• Technical documents to summarize innovative approaches to streamline evidence generation in each of the areas of neonatal sepsis, neglected tropical diseases and tuberculosis.
• Design and execution of a regional training event on best practices for paediatric clinical trials, including an agenda, training materials, and post-event summary.
• Report on engagements with regulators and industry partners to improve study design and accelerate paediatric evidence generation.
• National Data Mapping Report which identifies national data sources related to paediatric medicine safety and monitoring in four ASEAN countries.
• A detailed plan for establishing a national paediatric data hub, including governance, data sharing agreements, and technical infrastructure.
• A package of training resources for healthcare workers to be used at capacity strengthening events.
• Clinical Research Work Plan: GAP-f working group’s objectives and strategic work plan aligned with GAP-f Phase 3 strategy.
• Meeting & Webinar Summaries: Report on meetings and webinars, including key outcomes and next steps.

Skills and Qualifications

• Masters or PHD degree Life Sciences, Health Care field or an equivalent combination of education, training & experience.
• Previous experience in clinical research studies management; CRO/Pharma experience preferred.
• Minimum 5-7 years of experience in a related field.
• Ability to work remotely (across timezones) but collaboratively with multiple stakeholders.
• Experience of management of real-world evidence research in Asia.
• Experience of management of clinical trials in LMICs.
• Understanding of Asian context including regional partnerships and key stakeholders.

Skills/Knowledge

• Knowledge of standard tools (Word, Excel, PowerPoint, Teams and Zoom).

Languages and level required

Essential: Expert knowledge of English.

Desirable: Intermediate or basic knowledge of French or Spanish.

95.000 EUR (annual gross amount), type of contract: consultancy agreement, three years contract.

How to apply

You can use this Linkedin form or you can send by email (recruiting@pentafoundation.org) a signed CV including the following statement: I hereby agree for the processing of my Personal Data included in my application for the needs of the recruitment process in accordance with the General Data Protection Regulation EU 2016/679. Send all materials to recruiting@pentafoundation.org with ‘GAP-f Clinical Research Senior Consultant’ in the subject of the e-mail. If you have any queries, please email at recruiting@pentafoundation.org.

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