[Closing date: 15 April 2018]
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 (www.dndi.org).
The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit research and development organization that addresses global public health needs by developing and delivering new or improved antibiotic treatments, while endeavoring to ensure sustainable access. Initiated and incubated through close collaboration between WHO and Drugs for Neglected Diseases initiative (DNDi), GARDP is part of the implementation of the Global Action Plan on Antimicrobial Resistance that calls for new public-private partnerships for encouraging research and development of new antimicrobial agents and diagnostics.
GARDP’s mission is to work in partnership with the public and private sectors, to develop and deliver new treatments for bacterial infections where drug resistance is present or emerging, or for which inadequate treatment exists.
GARDP is currently hosted and facilitated by DNDi, which provides the scientific environment, necessary personnel, and infrastructure to ensure an effective start-up phase.
Purpose of the position
The GARDP Clinical Director will play a leading role in the clinical development of new drugs and treatments for AMR. S/he will be involved in the supervision, development, and regulatory review of clinical projects. S/he will ensure the successful implementation of Clinical Trials, according to Good Clinical Practice and ICH Guidelines. She/he will work with the project teams to ensure that the clinical trials meet their goals. S/he will lead interaction with Regulatory bodies. S/he will be expected to maintain close interaction with the GARDP R&D project team and to directly oversee the use of GARDP resources for given projects. The Clinical Director will report to the GARDP R&D Director and will provide managerial and clinical research leadership to a team of clinical programme/ project managers and CRAs in Geneva, as well as in Regional offices.
Specific job responsibilities
Patient safety, reporting directly to the Executive Director
- Accountable to the Executive Director, responsible for patient safety, including ensuring that GARDP clinical safety reporting meets all requirements and expectations (ensuring safety and risk management plans are in place appropriate to the development phase of the project, SAE reporting, pharmacovigilance for approved products (as appropriate), provision of annual and other safety reports, etc.) This also includes the management of any serious incidents associated with any clinical activity including the escalation and communication process and convening an appropriate senior management committee to oversee and manage the process.
Programme/project planning, support, and internal review
- Oversee project schedules and budgets with Programme leaders and with the R&D Director
- Oversee milestones, critical success factors, and key performance indicators for clinical programmes and projects
- Play a leading role as part of the R&D team in the development of the GARDP project portfolio
- Ensure that Pharmaco-vigilance strategy and support is in place in all programmes
- Ensure that Clinical Development Plans (CDPs) are in place in all programmes
- Be responsible and accountable for the sign off key relevant GARDP documents, such as the IB, clinical protocols (investigational and non-investigational), and other key regulatory documents
- Accountable for internal reviews of clinical protocols as well as coordinating review by the SAC
- Accountable for alignment of GARDP policies and processes with those for DNDi
- Participates to the Internal Scientific Review Committee (joint with DNDi)
Ensure regulatory compliance for projects
- Be familiar with current relevant pharmaceutical regulatory requirements especially pertaining to antibiotic drug development, work with teams in their interactions with regulatory authorities
- Be familiar with other international frameworks such as WHO PQ, the EML, etc.
- Ensure projects and investigators observe best practice, follow regulatory compliance, and keep appropriate documentation
- Work with teams to develop the regulatory strategy for clinical candidates
- Ensure that all clinical studies are performed to GCP standards and meet the highest ethical standards
- Ensure that all monitoring mechanisms are in place to ensure that clinical documentation, ethical, and regulatory submissions meet agreed quality criteria
Tasks and responsibilities for R&D staff
- Manage and supervise clinical R&D projects
- Assist in the selection of suitable projects and investigators
- Manage and supervise the team and have oversight over clinical R&D projects
Note: the position will play a key role in overseeing the set-up of relevant process and systems of the new GARDP legal entity, as pertaining to the tasks and responsibilities laid out here. This will be based on existing DNDi systems and additional staff will be put in place to ensure its successful implementation.
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
- Knowledge of managing global multicultural teams and strong ability to lead and motivate a team for optimum performance
- Highly organized and structured, demonstrating above average analytical skills
- Highly skilled in leading strategic programmes
- Excellent ability to manage large size programmes with budget management
- Excellent strategic thinking and leadership abilities, with strong management, negotiation, and advocacy skills
- Excellent ability to exercise high degree of independence to ensure programme delivery and explore new areas of activities
- Strong ability to interact with internal and external stakeholders in addition to proven communication skills in multicultural, multi-lingual environments
- Excellent communication, and public speaking skills, ability to convince, and represent DNDi at high level events
R&D technical skills
- Substantial experience gained in the pharmaceutical/biotech sector and/or non-profit sector of designing and implementing clinical development programmes
- In-depth knowledge of clinical trial principles, design, and methodology, incl. regulatory requirements and trends in clinical trial monitoring and safety issues
- Managerial and leadership qualities – the ability to inspire and develop teams, proven ability to effectively manage budgets, and resources
- Experience in infectious diseases and pediatrics highly desirable
- Strong analytical skills combined with the ability to think and act strategically
- The ability to build and sustain strong relationships with KOLs, other relevant medical experts, regulatory authorities, and other stakeholders
- Minimum 15 years’ relevant experience at senior management level and 17 years of management experience in public health or pharmaceutical industry
- Proven ability to work effectively in a team environment and matrix structure
- Experience building and leading teams
- Proven track record in resource mobilization/business development
- Proven track record in a leadership role in Clinical Development
- Medical degree required
- Postgraduate studies in life sciences, pharmacology, or equivalent
- Executive management training or managerial certification
- He/she reports to the GARDP R&D Director on all issues excepting patient safety, where the Clinical Development Director reports to the Executive Director
- He/she also reports functionally to the R&D Director for all issues related to the progress of the clinical portfolio
- Status: full time – permanent role
- Deadline for application: Accepting applications until 15 April 2018
- Only shortlisted candidates will be contacted.