Head of Programs Consultant – PANTHER at Drugs for Neglected Diseases initiative (DNDi)

Objectives of the position                                    

The Head of Programs plays a leading role in establishing and coordinating PANTHER’s operational architecture, and provides ongoing support during preparedness, response and inter-crises periods. The position is expected to create a conducive environment for Hubs to prepare and manage operational aspects of the Pandemic Preparedness & Response programmes, and therefore to maintain frequent interaction, together with PANTHER Director, with Hubs leaders, investigators, and partners.

The role ensures all clinical trial funded through PANTHER guarantee:

• the respect of rights, safety and protection of the persons participating in the clinical trial
• the respect of the applicable regulations and recommendations, and of the Clinical Trial Protocol
• accuracy, completeness and consistency of the data collected.
• implementation of the clinical trial according to the agreed timelines, quality and budget.
• the trial is inspection ready.

The role will be an advisor one for clinical trials directly funded by PANTHER’s partners.

Scope of work

Contributes to the design of PANTHER architecture

• Prepare the selection of diseases and epidemics/pandemics countermeasures (medicines, diagnostics, vaccines, devices…) for Scientific Advisory Board and Board of directors’ reviews.
• Prepare the selection of Hubs upon criteria defined by the Board of Directors.
• Serve as operational focal point for hubs and partners involved in the design and implementation of preparedness and response activities.
• Monitor milestones, critical success factors, and key performance indicators for project evaluation with partners.
• Develop project plans and budgets with relevant PANTHER colleagues and ensure effective and cost-efficient use of PANTHER resources.
• Develop and monitor risk management strategy and plans; enable review of projects

Establish preparedness infrastructure and programmes

• Together with Hub Leaders, assess and identify gaps in the network
• Propose infrastructure investments for hubs upgrading and alignment (e.g., screening, biobanks…)
• With hub leaders, develops tool-independent adaptive platform trials
• With hub leaders, ensures pre-approval mechanisms for the protocols during intercrisis period
• Together with Head of Operations, develops framework for operational preparedness (legal, financial, procurement ...) 
• Organize consultations and develop operating principles to be shared among the network for good clinical and laboratory practices. Ensures compatibility between ways of working across PANTHER network. Adopts / develops with relevant partners regulatory and QA approaches
• Assess trainings needs, develop and run training programmes with partners and providers accordingly
• Organize reviews/audits to ensure effective alignment among the network

Support the organization of response

Clinical trials will be established at the level of the Hubs, and for projects directly funded by PANTHER, the Head of Programs will ensure that all components for set up and documentation of the Clinical trials are in place.

• Ensure appropriate development an approval of the clinical trial documents: Clinical Trial Protocol, Statistical Analysis Plan, Data Management Plan, Informed Consent Documents, Case Report Form…
• Coordination of the clinical trial documentation.
• Oversight of the clinical trial set-up, follow up and reports.

Contribute to the leadership of PANTHER

• Prepare and participate to the Board of directors and Scientific Advisory Board of PANTHER
• Advise on appropriate external experts to enhance the review process
• Support the Director in managing external relationships with partners including manufacturers. Cultivate and maintain relationship with hubs and partners, develop synergies with other pandemic preparedness networks/initiatives (e.g. ISARIC, ALERRT, PANDORA).
• Supervise operational team members deliverables and related timelines, and mentor colleagues
• Participate in meetings and congresses represent PANTHER as required
• Lead on specific projects as per PANTHER director’s request.

The above list of responsibilities is not exhaustive. This job description may be subject to review.

Reporting line

• The Head of Programs reports to the Director of PANTHER

Line management

In the current initial design of the secretariat, we anticipate that the Head of Program will supervise:

• Project senior manager(s), deputizing the role in specific workstreams, as the number of hubs and programmes will grow
• A logistics senior manager, establishing and coordinating the logistics framework to prepare and ease the clinical trials in response and inter-crises times
• A Quality Assurance manager, developing and ensuring adoption of SOPs across the network
• Knowledge/training manager, coordinating preparedness training activities and developing knowledge building on good practices across PANTHER’s networks
• A Data manager coordinating data management solutions and providers
• Several positions above may start as consultants and others may also provide support (eg. Regulatory affairs).

Main internal interactions

The position will collaborate with other leaders to achieve PANTHER’s mission:

• with Resource development team for grant application, management, donor communication and reporting
• with Communication & Access team for preparation of communication tools, and public relations and access.
• with Operations for update, status and strategic discussion of the budget programme for PANTHER and all partners (e.g. outsourcing and partner engagement).

Specific job requirements

Skills and attributes

• High ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
• Very clear and systematic thinking that demonstrates strong judgment and problem-solving competencies. Highly organized and structured.
• Excellent communication, and public speaking skills, ability to convince and represent PANTHER at high level events. Knowledge of managing global multicultural teams.
• High ability to manage large size projects and teams with budget management. leadership abilities.
• High ability to interact, manage, negotiate with internal and external stakeholders
• High ability to exercise high degree of independence to ensure programme delivery and explore new areas of activities
• Excellent Leadership and People Management skills

R&D technical skills

• Excellent knowledge of the full Clinical Research/Development activities.
• Excellent knowledge of Regulatory (strategy, pathway to registration).
• Excellent knowledge of clinical trial operations (GCP, GMP, GLP and management of clinical trial).
• Excellent Technical writing skills (procedures, protocols and reports).

Experience

• Over 10 years in Senior role in conducting Clinical Trials and Clinical Operations.
• Significant experience of registration clinical trials and partner management in Africa.
• Experience of working in public and private sector is highly desirable.

Education & requirements

• Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level in clinical research or equivalent.
• Formal training or certification as required by the function.
• Fluency in English. Proficiency in French is desirable