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

A Clinical Leader within the Viral Diseases Cluster plays a leading role in the clinical development of relevant new drugs and treatments. This position is involved in the supervision, development, and regulatory compliance review of assigned clinical trial projects. The incumbent ensures the smooth running of clinical trials, according to DNDi SOPs, GCP and other ICH Guidelines. This position maintains and generates documentation pertaining to the management of the trial and manages partners and clinical research organizations to ensure the above goals are obtained. The Clinical Project Leader is expected to maintain frequent interaction with investigators, partners, and project team and to directly oversee the DNDi budget for the given studies. The incumbent oversees all clinical trial related activities and manages directly the (Sr) Clinical Project Managers.  This position guarantees:

• 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.
• Implementing the clinical trial according to the agreed timelines, quality and budget.
• Ensures that the trial is inspection ready
• Participation to the development strategy and ensure implementation of strategy at the level of clinical trial.

Specific job responsibilities

Project leader responsibilities

• Oversee the execution of the approved project plans, identification of critical success factors and indicators for project evaluation
• Accountable for the project’s deliverables
• Lead the project team
• Coordinate with functional leadership on project activities
• Lead the development and/or implementation of the project integrated clinical development plan
• Support the CPM’s or the CRAs (when no CPM in place) to ensure that the investigators implement rigorous and quality clinical studies that meet ICH standards
• Ensures efficient and cost-effective use of DNDi resources
• Organize regular project reviews and team (core and extended) meetings, inviting other DNDi members as appropriate
• Produce and coordinate materials and presentations for the SAC and DAC project reviews
• Review the progress reports at interim and formal management reviews
• Advise on appropriate external experts to enhance the review process as required

Clinical trial leader responsibilities

Project management

• Planning, set-up and follow-up of the clinical trials,
• Follow-up of the clinical trial progress: monitor milestones, compliance with the deadlines, and presents the clinical trial progress to the Disease and Initiative team
• Selection and follow-up of the subcontractors and partners during the clinical trial
• Management of clinical budgets and invoices
• Development of clinical trial tools
• Interaction with Data and Safety Monitoring Board Members 
• Support in the development project plans and budget plans
• Provide progress reports on individual projects including budget updates on a regular basis.

Clinical trial documentation

• Finalize the development and secure 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.

DSMB (Set-up phase and proceedings)

• Evaluates directly, or by oversight of the (Sr) Medical Manager and the CPM, the need or not for a DSMB (Data Safety Monitoring Board) with the validation of the Direct Manager and the Medical Director, and documents the decision, and propose the DSMB chairperson and ether DSMB members 
• Defines directly, or by oversight of the (Sr) Medical Manager and the CPM, the DSMB operating procedure (detailed in the DSMB charter) ensuring proper DSMB development, signature, filing approval as defined in this SOP together with the CPM.
• Ensures submissions to Ethics Committees (EC)/Institutional Review Boards (IRB) or Regulatory Authorities (RA) of DSMB related information if required as per local regulations (DSMB charter directly or by oversight of (Sr) Medical Manager and the CPM.
• Possibly attends open session of DSMB meeting, as described and agreed by all parties in the DSMB charter
• Ensuing DSMB procedures are followed, including recommendations distributions and DSMB documentation filing as defined in this SOP directly, or by oversight of the (Sr) Medical Manager and the CPM.

Clinical trial set-up

• Together with the Head of HIV Disease, defines the study specific requirements for conducting a specified clinical trial
• Defines the requirements that the potential trial site must have for conducting a clinical trial and selects the site with the support of CPM (or the CRAs (when no CPM in place)
• Management of the clinical trial set-up:
  • Administrative steps (e.g. submission to Competent Authorities and Ethics Committees…)
  • Investigators' selection and Investigators' Meeting
  • Coordination of the logistics (sending the Investigational Medicinal Products to the trial sites)
• Liaison with the CRAs for appropriate trial site set-up
• Maintenance of the clinical trial documentation

Clinical development plan & clinical trial protocol

• Participates in the Clinical Dev. Plan team 
• ls a mandatory member of the CDP Teams Reviews 
• Is in charge, directly or through oversight of the CPM, of the development of the Clinical Trial Protocol Synopsis, the Clinical Trial Protocol and any Clinical Trial Protocol Amendment(s), for validation by the Director of the HIV HCV Initiative prior to submission to the Medical Director
• Works on the Master Informed Consent (MICF) documents as well as any updates
• Participates to the CSR (Clinical Study Report) Kick-off meeting.
• Support the clinical data management activities associated with the conduct of clinical trials pertaining to the program
• Ensure that safety and quality standards are integrated in planning.
• Ensure regulatory compliance in planning

Monitoring (set-up phase)

• Designates or oversees the designation by the CPM an author for the Monitoring Plan, determines content contributors and designates reviewers of the Monitoring Plan and updates and approves the Monitoring Plan as required
• Ensures, directly or by CPM oversight that the appropriate members (e.g. CRA’s) have been trained before the first Monitoring visit occurs.
• Ensures, directly or by CPM oversight collaborative support from Data Management, PV and other functions as required, to develop the trial specify documentation needed for the trial, and inform the Procurement function, when applicable.

Oversight of the clinical trial follow-up and clinical trial report

• Follow-up, directly or by oversight of CPM of the trial allocated budget
• Liaison with the CPM or the CRAs (when no CPM in place) for appropriate site monitoring
• Coordination, directly or by oversight of the CPM of the clinical trial logistics (sending, return, destruction of the study supplies)
• Management, directly or through CPM, of possible Clinical Trial Protocol Amendments, other follow-up issues and possible administrative steps (e.g., submissions to Competent Authorities and Ethics Committees) during the clinical trial
• Management directly or through CPM of the Serious Adverse Events and other safety issues during the clinical trial
• Follow-up, directly or through CPM of the subcontracted data management and statistical activities
• Notification of the end of the clinical trial
• Coordination of the development of the Clinical Study Report and its appendices
• Oversight of Maintenance of the clinical trial documentation.

Act as clinical operations representative for the HIV Disease

• Participate as active member of a Resource management global platform and use the resource management tool for budgeting and monthly allocations tracking in coordination with the Head of Clinical Operations and the R&D Coordination team
• Drive a mindset of flexibility, being nimble, being ready to jump into another area
• Keep track of what the teams are doing, the capability, skills, and utilization rate of resources 
• Participate and/or lead expert groups to lead on projects in these areas and propose upskilling and trainings. Experts will be responsible for, but not limited to process development and training, planning (e.g. Study start up, Study closeout), data quality, monitoring and resource management
• Resolve issues on clinical operations before escalation to the Head of Clinical Operations, deploying facilitation, conflict management and negotiation /mediation skills
• Have Disease or Regional oversight accountability by transversally animating and leading the office clinical operations resources with regards to the activity/expertise highlighted above.
• Act as contributing manager to clinical development team employees for appraisals

Nairobi-Regional Management Team

• Is part of the regional management team, and takes part of the development of the regional strategy under the supervision of the regional executive director
• Is part of the preparation and implementation of the regional Action Plan.
• Participates to the preparation of the annual budget, as well as their regular revisions.
• Identifies risks potentially impacting projects and/or DNDi activities as well discuss them to address and suggest mitigation strategies with the other MT members.
• Participates in the monthly management team meetings in the Region as well as ensure a fluid regional internal communication

Reporting line

• The Clinical Project Leader reports to the Head of HIV
• Secondary reporting line into the Head of Global Clinical Operations

Interactions

• Works with R&D and Medical affairs teams, fundraising, finance and planning teams, and the regional offices
• This role has frequent interaction with DNDi staff and external stakeholders to coordinate provision of work or to advocate, persuade and gain support or commitment. This role represents DNDi for a program/service area and develop and maintain relationship with current and future partners.

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
• Excellent communication, and public speaking skills, ability to convince and represent DNDi at high level events
• Knowledge of managing global multicultural teams
• Highly organized and structured
• High analytical skills
• High ability to lead large strategic projects
• 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

• Excellent knowledge of Drug Discovery/Development
• Excellent knowledge of Clinical Research/Development
• Excellent knowledge of Regulatory (GCP, GLP and GMP)
• Excellent knowledge of Disease/academia knowledge
• Excellent Technical writing skills (procedures, protocols and reports)

Experience

• Over 10 years in Senior role
• Proven ability to work effectively in a team environment and matrix structure
• Experience of working in public and private sector is highly desirable
• Has experience in leading projects and managing multidisciplinary teams
• Experience in dealing with multiple external partners and institutions

Education

• Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level