[Closing date: February 5, 2017]
Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for neglected diseases.
DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research and Development Partnership, a not-for-profit research and development organization to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all.
Since its inception, DNDi has developed seven new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, paediatric HIV with several new drug candidates in the R&D pipeline including two for sleeping sickness. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates
DNDi is seeking a Pharmaceutical Development Manager. Working with public and private sector partners, NGOs and CSOs, through R&D networks created based on South-South and North-South cooperation, DNDi aims to offer medical innovations taking into account the patients’ needs.
The role is based in Geneva and involves regular international travel.
The Pharmaceutical Development Manager will play a critical role in the delivery of non-clinical safety studies and Chemistry, Manufacturing and Control (CMC) activities for projects at all stages of R&D.
Tasks and Responsibilities
Manage non-clinical and CMC activities for assigned R&D projects:
- Establish strategies that meet project and regulatory requirements, in collaboration with the Head of Pharmaceutical Development and expert consultants
- Develop and maintain suitable project schedules, budgets and risk mitigation plans with project teams and external service providers
- Liaise with service providers on a regular basis to monitor progress against milestones, as well as resolve technical, quality or resource issues smoothly
- Review and manage technical data and documentation to ensure timely action, compliant storage and efficient retrieval
- Prepare project updates, presentations and reports for both internal and external stakeholders (e.g. DNDi senior management, Scientific Advisory Committee, donors)
- Prepare regulatory documentation (non-clinical and quality modules) and support regulatory submissions
- Develop and maintain project management skills and technical knowledge to oversee non-clinical and CMC activities effectively
General operational management of non-clinical and CMC service providers:
- In collaboration with the Procurement Officer, identify and evaluate potential external service providers, taking into account technical capabilities, quality requirements and cost-effectiveness
- Organize quality agreements and audit schedules for service providers, monitor and improve their performance, and maintain a qualified service providers list
- Maintain awareness of the contract research and manufacturing environment and relevant service offerings
Development and management of pharmaceutical quality systems:
- Support the development, implementation, maintenance and monitoring of quality systems for non-clinical safety studies and CMC activities to assure compliance with GLP, GMP and GDP requirements
- Manage DNDi standard operating procedures relating to pharmaceutical quality
- Maintain awareness of applicable guidelines and regulations
- He/she reports to Head of Pharmaceutical Development
- Responsible for managing non-clinical and CMC service providers to agreed timelines and financial targets
- No direct reports
- He/she works with assigned project teams and Heads of Programs to deliver new treatments for neglected diseases in the DNDi portfolio
- He/she establishes and maintains effective working relationships with a range of external contract research organizations, contract manufacturing organizations, industrial partners and expert consultants
Skills and Attributes
- Robust knowledge of non-clinical safety studies, CMC activities, regulatory requirements, and their relationship to the drug development process
- Strongly supportive of the DNDi mission and vision, and understanding the organization’s values and business model
- Demonstrated expertise in project management, applied preferably within a multi‑disciplinary R&D environment, with a strong track record of successful delivery
- Substantial experience of managing international business relationships with external project partners and service providers
- Ability to interrogate and interpret data, problem-solve, make sound decisions and recommendations
- Evidence of a quality/continuous improvement mindset
- Capacity to plan and organize own work with autonomy
- Evidence of effective interpersonal skills and collaborations across different organizational levels and boundaries
- Competent in use of spreadsheet and planning software
- Minimum 6 years’ relevant experience in which at least 4 years at Senior Officer level
- Proven ability to work effectively in a team environment and matrix structure
- Experience of working in public and private sector is highly desirable
- Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level
- Degree in relevant scientific discipline (i.e. chemistry, pharmacy)
- Fluency in English
- Proficiency in local languages desirable
- Very good knowledge of Microsoft Suite
- Deadline for application: Accepting applications until February 5, 2017.
- Only shortlisted candidates will be contacted.