Regional Clinical Leader at Drugs for Neglected Diseases initiative (DNDi)

Purpose of the position

With the increased portfolio of Diseases in the DNDi Africa Nairobi office, the volume and variety of trials carried out in the eastern Africa region has increased, resulting in the need for a senior scientific leader to coordinate these concurring activities and bring senior R&D expertise to ensure the efficiency and high quality of the clinical operations.

DNDi has created a new senior position to sit on the regional leadership team in their capacity of Regional Clinical Leader and work very closely with the Geneva Headquarters, where the Disease team leadership is located. The Regional Clinical Leader is accountable for leading and ensuring quality of science and clinical activities of the regional office. The Regional Clinical Leader will enhance regional office standards and SOPs, aligning them with global standards and SOPs, and will oversee the clinical operations team delivery by ensuring clinical development projects are well planned, appropriately resourced and executed in a timely fashion in collaboration with the disease area teams.

S/he will lead transversal R&D resources located in the region, coordinating the allocation of resources to several disease programs.

The Regional Clinical Leader is thus accountable, together with the Disease team senior managers, for clinical development and operations of the Nairobi office.

This position is part of the regional management team and works closely with the R&D department based in Geneva.

Specific job responsibilities

Clinical Operations Management

To oversee clinical trial related activities within the region by providing leadership to the clinical operations team in Nairobi for efficient and effective delivery of clinical studies, including:

• Provide advice and experience on clinical study design in collaboration with the Disease program teams.
• Lead effective clinical implementation in the region in line with team objectives defined in the yearly Action Plan
• Supervise new clinical sites identification
• Ensure qualified and trained resources are allocated to disease programs, and ensure effective use of pooled resources at the office level
• Leverage global expertise (medical affairs, QA/QC, translational research, CMC) to support study implementation
• Contribute to Pharmacovigilance activities

To guarantee clinical trials are conducted under good practices:

• Respect of the rights, safety and protection of the persons participating in the clinical trials
• Knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) Good Clinical Laboratory Practice (GCLP) and International Conference on Harmonization (ICH) guidelines
• Respect of the applicable regulations and recommendations, and of the Clinical Trial Protocols while respecting the national regulations and laws of the countries where the clinical trials are carried out
• Accuracy, veracity, completeness, consistency of information collected with the source data compliance with the objectives, the planning, the timelines and the clinical trial budget

To contribute to access-related activities, in close coordination with Disease programs and Regional director.

Data centre management

• Supervise the data center work and development, in terms of prioritization, accountability for results and set delivery Key Performance Indicators (KPIs)

Team management

• Supervise and mentor clinical managers and head of data center
• Coordinate the allocation of pooled resources for clinical trials development
• Develop and manage planning tools and performance indicators for the office for clinical operations and contribute to global reporting
• Accountable for Nairobi office R&D team training, knowledge and skills development
• Part of the regional management/leadership team

Stakeholder outreach

• Identify and construct R&D specific partnerships at regional level
• R&D representational role with local R&D networks
• Participation to LEAP platform activities

Contribution to global R&D work and planning

• Participate in R&D team global teleconferences
• Contribute to the preparation of the annual Action plan
• Contribute to DNDi R&D publications
• Attend R&D global events as required 

Job requirements

Skills & 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
• Excellent communication, and public speaking skills, ability to convince and represent DNDi at high level events
• Knowledge of managing global multicultural teams
• Willingness to travel regularly in the region of eastern Africa and internationally
• Highly organized and structured
• High analytical skills
• High ability to manage large size projects with budget management
• Very strong strategic thinking and leadership abilities
• Excellent management, negotiation, and advocacy skills
• High ability to exercise high degree of independence to ensure program delivery and explore new areas of activities
• High ability to interact with internal and external stakeholders
• High ability to lead and motivate a team for optimum performance 

R&D technical skills

• ICH and GCP knowledge
• Medical affairs, QA/QC, PV
• An understanding of regulatory affairs (regional agencies, EMA Art. 58, FDA)
• Experience in data management for clinical trials

Experience

• Over 10 years in clinical project management
• At least 10 years’ experience in clinical research at least 4 of which are as Project Manager for clinical trials at a Contract Research Organization (CRO)/ biotech or pharmaceutical organizations
• Proven record in managing and maintaining effective leadership with the clinical trial managers, partners and stakeholders in Africa
• Experience with Phase II – IV clinical trials. Phase I clinical trials experience an added advantage
• Proven record of scientific publication in high impact journals

Education

• MD mandatory
• Postgraduate training

Other Requirements

• Fluency in English
• Proficiency in local languages desirable
• Excellent knowledge of Microsoft Suite