Purpose of the position
The NTD Cluster Director for HAT Filarial Chagas Cluster takes the leadership in defining and supervising the Disease strategies for the cluster portfolio and identifying new opportunities in development and access to affordable drugs and ensuring success of clinical development of new therapies, while managing the Cluster team through supervision of the senior leaders.
The NTD Cluster Director is expected to deliver on programme objectives and deliver on programme objectives to meet the needs of the patients affected with HAT, Filarial and Chagas diseases and ensuring a healthy pipeline. The NTD Cluster Director is expected to represent DNDi at a global level, communicating at high level conferences and events to promote partnerships between private and public sector and advocating for removing barriers to access and treatment. The Director is expected to maintain and grow a large network of stakeholders and partners.
The NTD Cluster Director manages a team in Geneva, operations across 4 continents and DNDi offices plus partner organizations.
The NTD Cluster Director is a member of the Global Executive Team.
Specific Job Responsibilities
Accountable for ensuring that the scientific quality and review of the diseases strategy and projects follow DNDi processes under the guidance of the R&D Director, and accountable for review of documents presented to the Scientific Internal Review Committee and to the DNDi’s Scientific Advisory Committee (SAC) for the HAT Filarial Chagas Diseases Cluster
· Is accountable for the review of the disease strategies once a year by the Scientific Advisory Committee (SAC) and by the SIRC, if and when needed
· Is responsible for the systematic scientific review of the projects according to the strategic milestones/stage gates.
· In collaboration with the Discovery Director, the Director of Pharmaceutical Development, the Medical Director, and the Head of Clinical Operations, ensures end-to-end planning and execution of R&D projects
· Ensures that the cluster projects are adequately staffed and funded both within the disease teams but also through alignment with the other R&D teams (Discovery, Pharma. Dev, Clinical Ops, Medical Affairs, other Disease Cluster Directors) and the R&D Director
· Contributes to the current and new Strategic Plan reviews and collaborates on new opportunities
· Accountable for ensuring that capacity building is implemented in regions in order to support clinical trials in their cluster. Making sure that capacity is built and supported during trial conduct, as an important responsibility
Oversight of Clinical Activities
· Accountable for the quality of the clinical activities and complying with DNDi’s standards, inclusive of being inspection ready at all times.
· Responsible for directing and guiding teams on the Clinical Development Plan and the Product Development Plan production then approving it prior to approval by the R&D Director (for the clinical development and scientific parts) and input from the Scientific Internal Review Committee (SIRC) Ensures clinical development and implementation projects run on time and according to plan takes corrective action when necessary
· Accountable that all staff members are GCP trained
· Reviews reports of critical major quality issues and suspected misconduct, jointly with the Medical Director and the Head of Disease, and brings it to the attention of the R&D Director
· Accountable for having strategic regulatory approaches in place
· Accountable for the regulatory plans, and for overall risk assessment including in the CPD/PDP
· Responsible for ensuring that there are Safety risk management plans in compliance with SOP and PV processes in place
· Responsible for ensuring prompt communication of safety issues to the Medical Director
Head of Disease responsibilities (if directly leading a Disease area)
· Accountable for the Clinical Development Plan (CDP)
· Accountable for sign off of DNDI protocols, and accountable for proposing the study design in accordance to the CDP
· Accountable for the DNDi essential documents (IB, SMP) - to have them in place, and that they are regularly updated and approve them (with exception to the IMPD)
· Accountable for ensuring clinical studies are run according to the prescribed standards and specific regulatory guidance.
· Accountable for clinical studies results, addressing critical findings and integrity and validity of data.
· Responsible for oversight of the management of the clinical teams with appropriate escalation of medical issues to the medical director and executive director (ref PV SOP 02)
· Accountable to provide the registration package ready for submission, and accountable for interactions with regulatory authorities
· Responsible for ensuring safety, wellbeing and medical supervision of trial participants and clinical safety reporting in line with GCP and DNDi requirements (if medically qualified)
· Responsible for identifying an appropriately qualified person to ensure safety, wellbeing and medical supervision of trial participants and clinical safety reporting in line with GCP and DNDi requirements (if not medically qualified)
· Co-chairs the protocol review committee for patient studies in their programme.
· Responsible for and oversight of publications and timely publishing of results.
Medical Accountability (if not delegated)
· Assumes or delegates preferably the responsibility of the medical monitoring plans to the (Sr) Medical manager and ensures directly or by oversight that medical monitoring is appropriately implemented for clinical trials within their programme.
· Provides medical expertise to unit/department clinical teams, as needed.
· Maintains medical expertise in the therapeutic domain and maintains up to date Good Clinical Practice training.
· Accountable for the production of the Medical Monitoring Plan for the trial, with support from the (Senior) Medical Manager, CPM, Pharmacovigilance function, data management and other functions as required.
· Is accountable for ensuring appropriate escalation of safety signals for drugs in their programme in accordance with DNDi pharmacovigilance SOPs.
· Interacts as needed with global regulatory authorities regarding the trial application, conduct, safety concerns and the presentation and interpretation of results, in partnership with the Medical Director.
Management of NTD HAT Filarial Chagas Disease Cluster, R&D
· Orchestrates a complex program management, composed of senior team management through clear delegation of roles and responsibilities, operations and delivery planning and monitoring, stakeholders and partner’s careful management and maintaining of key advocacy/government relationships
· Translates the disease strategies into effective operational plans and deliveries.
· Ensures and coordinates the development of the annual plan and budget for the diseases in the Cluster?
· Supervises the detailed planning of annual work and business planning, with careful setting of timelines and milestones
· Is accountable for sound project portfolio management
Engaging with external partners, representation
· In concert with the R&D Director and the executive team maintains good relations at high levels with stakeholders in the Cluster of diseases arena and keep abreast of political developments to ensure DNDi remains on top of the latest developments
· Is responsible to make sure there is an access strategy and plan for the products, in collaboration with the DNDi regional offices, access leads and local stakeholders/partners.
· Contributes to treatment access through negotiations with partners, supervision of business development efforts
· Identifying new partners for the Cluster as well as potential new programs
· Identifying new sources of revenue for the Cluster, and be at the heart of innovative new proposals pitched to donors + cultivate relationship with donors
· Collaborates with business development director on opportunities.
· Collaborates with the Director of External Affairs on activities related with Policy, Advocacy, Fundraising and Communication
· The Cluster Director will sit on the Scientific Internal Review Committee meetings and contribute to the discussion by providing updates on their areas of responsibility and contribute to the group discussion and decision making on a broader set of topics that are of strategic importance to the organization
Exploratory Responsibilities
The NTD HAT Filarial Chagas Cluster Director is responsible for exploratory activities of the Cluster, into new disease areas that have been identified of strategic importance for DNDi
Reporting line
• As Director of the NTD HAT Filarial Chagas Disease Cluster, they are responsible for overall success of the program with a direct report to the R&D Director.
• The position supervises several senior staff.
Job Requirements
Skills and Attributes
Skills and Attributes:
· Excellent 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 skills in multicultural, multi-lingual environments
· 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
· Excellent analytical skills
· Excellent ability to lead large strategic programs
· Excellent ability to manage organization wide programs with budget management
· Excellent strategic thinking and leadership abilities
· Excellent management, negotiation, and advocacy skills
· Excellent ability to exercise high degree of independence to ensure program delivery and explore new areas of activities
· Excellent ability to interact with internal and external stakeholders
· Excellent ability to lead and motivate a team for optimum performance
R&D Technical Skills
· Knowledge of Drug Discovery/Development
· Excellent knowledge of Clinical Research/Development
· Knowledge of Regulatory (GCP, GLP and GMP)
· Excellent knowledge of Disease/academia knowledge
· Strong command of technical writing skills (procedures, protocols and reports)
Experience
· Minimum 17 years’ relevant experience at senior management level and 20 years of management experience
· Experience with public health programs and liaising with appropriate government structures (MoH, regulatory bodies), preferably in several regions of the world is an asset
· Experience in the pharmaceutical industry is an asset
· Proven ability to work effectively in a team environment and matrix structure is critical
· Experience building and leading teams in a startup environment
· Proven track record in resource mobilization / business development
Education
· Postgraduate studies in life sciences, pharmacology, or equivalent is required
· Ph.D. in public health or related fields is an asset
· MD is an asset
· Executive management training or managerial certification is an asset
Other Requirements
· Fluency in English
· Proficiency in other languages desirable
· Willingness and ability to travel globally
· Excellent knowledge of Microsoft Suite
Other information
· Status: Full time – Permanent role
To apply
· Please submit your application using the online form
· Deadline for application: accepting applications until 18 February 2022
· Only shortlisted candidates will be contacted
· Application submission for this position may close early if we have enough suitable applicants
The Drugs for Neglected Diseases initiative (DNDi) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases that affect millions of the world’s poorest people.
Together with more than 200 public research and industry allies worldwide, we use the power of partnership, innovation, open science, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people. Driven by collaboration, not competition, and by patients’ needs, not profits, we promote equitable access, foster inclusive and sustainable solutions, and advocate for a more effective global biomedical R&D system that meets the needs of neglected patients.
Since our inception, DNDi has delivered nine new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, hepatitis C, and malaria that have saved millions of lives. We now aim to deliver an additional 15-18 new treatments by 2028 – addressing R&D gaps for neglected tropical diseases and viral infections, including new pandemic-prone diseases (such as COVID19) and climate-sensitive diseases (such as Dengue) with a focus on the needs of patients in low- and middle-income countries.
With 250 employees of 37 nationalities located in nine offices on four continents, DNDi is committed to diversity, equity, and inclusion as essential parts of our culture and key drivers of our success. We encourage candidates of diverse profiles and backgrounds to apply.
The R&D organisation drive therapeutic innovation from the lab bench to the patient bedside. it develops DNDi’s portfolio of drug candidates from the onset (with the design of target product profiles) to the end point (enabling patients’ access to the new treatments). With members located in various DNDi offices worldwide, R&D teams are key enablers of DNDi’s virtual research model which relies on collaborative partnerships with industry and science partners worldwide, fully inclusive of LMICS clinicians and researchers. Projects are run by project leaders and team members regrouping needed expertise from all DNDI functions, beyond R&D.
The R&D organisation include three clusters of Diseases expert teams: NTD/Mycetoma and Leishmaniasis, NTD/Chagas-Filarial-HAT and Viral Diseases. Medical Affairs (Pharmacovigilance, Clinical Quality and Assurance, Regulatory and Translational Sciences), Global Clinical Operations, Discovery and Pharmaceutical Development teams complement the R&D expertise. Projects review, Science and strategy is managed by the Scientific Internal Review Committee (SIRC); The R&D Coordination team lead the R&D organisation for all other topics.
