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 affecting 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 12 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 11-14 new treatments by 2028 – addressing R&D gaps for neglected tropical diseases and viral infections, including new pandemic-prone diseases (such as Covid-19) and climate-sensitive diseases (such as dengue) with a focus on the needs of patients in low- and middle-income countries.
With more than 250 employees of 33 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 organization drives 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 organization includes 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, R&D Portfolio and Planning, 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 organization for all other topics.
Purpose of the position
The Pharmaceutical Development Leader plays a critical role in the delivery of Chemistry, Manufacturing and Control (CMC) and supply activities for projects at all stages of R&D.
The role supports and deputises for the Pharmaceutical Development Director to advance the pharmaceutical development activities across the disease areas and ensure adequate resourcing of the different projects.
The position leads CMC activities for large scale projects, including strategy, budget and timelines in close collaboration with DNDi’s translational and disease teams and external partners.
This role provides guidance and supervises CMC activities on multiple projects, including the work of other team members, external contract development and manufacturing organisations, and external consultants and advisors.
The incumbent is responsible for the evaluation and selection of appropriate API and drug delivery technologies to meet the needs of the project at different stages of development.
The role contributes to the development and management of pharmaceutical quality systems to ensure compliance with GLP, GMP and GDP requirements, and implements new ideas and tools for managing these efficiently.
The Pharmaceutical Development Leader turns the strategic intent into operational reality through the design, development and implementation of programme/projects or the provision of services to the entire organisation. Plans, integrates and coordinates work to deliver a comprehensive programme or a service platform and manage operational aspects of the delivery. Develops new approaches, techniques or policies and establishes important guidelines. Proposes strategic direction, staffing and budget decisions to her direct supervisor.
Scope of work (results)
The Pharmaceutical Development Leader role affects delivery of a programme/projects and success of the team and directly impacts on the output of DNDi in the short to medium terms. Information disseminated to external communities affects the image of DNDi, impacting on the commitment of stakeholders and resource mobilisation.
Specific job responsibilities
Lead CMC effort for projects at all stages of development
- Lead pharmaceutical development efforts within complex disease programmes by advancing candidates through clinical development phases.
- Deputise for the Pharmaceutical Development Director, notably by contributing to key internal and external meetings and through the approval of quality and regulatory documents.
- Establish pharmaceutical development strategies that meet both project and regulatory requirements and set individual strategic goals accordingly, including the evaluation and selection of suitable API and drug delivery technologies.
- Act as pharmaceutical development point of contact and active member of joint development committees with industrial partners.
- Act as a project leader for discrete projects within the DNDi portfolio.
- Review and approve regulatory documentation (non-clinical and quality modules) and support regulatory submissions and associated interactions with regulatory authorities.
- Develop CMC project plans, identify associated risks and establish mitigation strategies to support the clinical development plans.
- Progress individual projects by directly managing service providers or supporting, advising and mentoring other team members.
- Resolve technical, quality or resource issues smoothly and escalate as needed.
- Maintain awareness of scientific and regulatory CMC development as well as the contract research and manufacturing environment and relevant service offerings.
Manage team of pharmaceutical development colleagues
- Supervise 1-5 colleagues within the pharmaceutical development team as well as consultants working for the team.
- Provide technical guidance, direction and coaching to team members to progress projects effectively.
- Define clear priorities for the team to achieve success in delivery of project goals against the annual action plans.
- Develop colleagues, monitor their performance and progression through their personal development plans
- Support the Pharmaceutical Development Director in prioritising and resourcing the projects adequately.
Develop pharmaceutical quality systems
- Identify opportunities to improve the pharmaceutical quality system and work effectiveness.
- Define best practices for the pharmaceutical development department, in compliance with applicable guidelines and regulations.
- Maintain awareness of the latest GMP guidelines and regulations.
- Review and approve quality documentation.
The above list of responsibilities is not exhaustive. This job description may be subject to review.
- The role reports to the Pharmaceutical Development Director
- This role supervises 1-5 permanent or contract staff members.
- The position works with assigned project teams, translational sciences department, disease teams and portfolio and planning leaders to deliver new treatments for neglected diseases in the DNDi portfolio.
- The incumbent has frequent interactions with DNDi staff, senior management and external stakeholders to coordinate provision of work or to advocate, persuade and gain support or commitment and represents DNDi for a programme/service area and develop and maintain relationship with current and future partners.
- The Pharmaceutical Development Leader may be assigned the role of Project Leader for key DNDi development candidates, leading an internal project team of 6-12 colleagues depending on the stage of development.
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 programme 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 (non-clinical, CMC, regulatory)
- Good knowledge of clinical research/development
- Very good knowledge of regulatory (GCP, GLP and GMP)
- Excellent technical writing skills (procedures, protocols and reports)
- Evidence of a quality/continuous improvement mindset
- Over ten 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
- Proven track record of successful project delivery
- Advanced post graduate degree or graduate degree in relevant subject (e.g., chemistry, chemical engineering, pharmacy)
- Fluency in English
- Proficiency in French desirable
- Excellent knowledge of Microsoft Suite, including planning software
- Status: Full time position, permanent role
- Starting date: 1 March 2023
- Please submit your application using the online form
- Deadline for application: Accepting applications until 3 February 2023.
- Only shortlisted candidates will be contacted.
- This position might close early if we have filled the position.