Clinical Development Lead
CEPI is looking for a Clinical Development Lead as part of its growing Vaccine Development team based in London. This role reports into the Head of Clinical Development and will play a key part in CEPI’s mission.
If you are interested in joining the CEPI team and think you have the appropriate qualifications for this role, please read the detailed job description below and follow the instructions for applying.
The primary role of the CEPI Vaccine Development team is to provide the technical leadership to advance our vaccine platform portfolio working closely with the Vaccine Science Team, partners and cross cutting teams across CEPI.
The Clinical Development Lead reports to the Head of Clinical Development and will be the subject-matter expert in the clinical development of vaccines, supporting the development of CEPI’s portfolio of vaccine projects and the attainment of CEPI’s broader and longer-term goals of vaccine delivery and access, preparedness and rapid response. They will be responsible for facilitating CEPI-funded projects in a manner that guarantees clear communication and project continuity which adheres to CEPI guidelines and governance and ensures compliance with national and international regulations and current ICH GCP guidelines.
The successful candidate will provide advice and support in the clinical development and safety oversight of these vaccines; contribute to clinical trial capacity strengthening in countries affected by the three priority pathogens.
We are looking for someone who can interact with research groups at a global and local level as well as corresponding health and regulatory authorities in the preparation for and the implementation of clinical trials. Understanding sensitivities in multiple countries, especially those affected by the pathogens, will be critical.
- Support the development and management of the overall clinical project strategy, clinical development plan, oversight of outsourced clinical work and associated budget of the awardees
- Ensure the highest quality of clinical research and operations support is provided to all vaccine clinical development projects in compliance with CEPI’s clinical trials policy, SOPs, regulations and current ICH GCP guidelines
- Monitor timely and accurate accomplishment of key clinical project milestones and review clinical data for milestone decision processes
- Ensure clinical funding and resources are appropriate to successfully meet the clinical requirements of the program
- Attend Independent Data Monitoring Committees of the awardees
- Advise on the pre-clinical development of new vaccines, where requested, and guide awardees in the selection and interpretation of immunological read-outs for clinical trials
- Represent CEPI at international scientific conferences and in meetings with national authorities and regulators
Education, Experience, Knowledge and Skills
This is an opportunity for someone who can demonstrate that they have:
- Medical Doctor qualification with specialist experience in Infectious & Tropical diseases and vaccinology
- A minimum of 3-5 years of vaccine clinical development experience in industry, public health or public sector
- International experience (ideally in LMICs) and ability to work on multinational teams
- Strong interpersonal skills, team player with ability to lead projects, able to work in different cultural environments and interact with regulators, academia and industry. Experience of collaborating with LMIC’s
- Excellent command / highly proficient in spoken and written English
- Solid computer literacy with standard software packages, e.g. Microsoft Excel, PowerPoint & Word
- High level of personal integrity
- Project management and / or regulatory experience is highly desirable
Travel and Location Requirements
International travel will be required on a frequent basis.
What We can Offer You
- Experience from the international effort on developing vaccines against EIDs and accelerating vaccine development response to outbreaks
- An exciting job opportunity at a newly established international organisation focusing on funding and facilitating vaccine development
- Attractive benefit package including holidays, health benefits and private pension arrangements
- Competitive salary in the region of GBP 90,000 to 110,000 subject to expererience
How to Apply
If you are interested in being considered for this position, please send your Curriculum Vitae along with a covering email / letter to email@example.com
Closing Date for applications is 23:59 on Friday 26 April 2019
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