Norway Job Openings
cepi
Clinical Development Science Lead
Oslo
October 14, 2024
Vacancy
Vacancy reference
VAC-0332
Department
Clinical Development
Location
Oslo / London / Washington DC
Close date
20/10/2024
Job description
About CEPI
Launched in 2017, the Coalition for Epidemic Preparedness Innovations (CEPI) is an international coalition of governments, academic, philanthropic, private, public, and intergovernmental institutions whose vision is to create a world in which epidemics and pandemics are no longer a threat to humanity. Our mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI played a central role in the global response to COVID-19, creating the world’s largest portfolio of COVID-19 vaccines – seven of which are approved for global or domestic use - and co-leading COVAX, the global initiative to support equitable access which supported the delivery of over 2bn vaccine doses globally. CEPI has CEPI has contributed to a number of scientific breakthroughs in vaccine development against other infectious diseases, including the first ever licensed Chikungunya vaccine and the first Nipah and Lassa virus vaccines into Phase 1 trials.
As COVID-19 has demonstrated, emerging infectious diseases represent an existential threat to our way of life. COVID-19 is not the first pandemic of the 21st century, and unless we act now, we can be sure that it will not be the last. Unlike some of the other big threats that humanity faces, we have the tools to systematically reduce and even eliminate the risk of future pandemics. It is vital that we capitalise on the rare alignment of political will, practical experience, and technical and scientific progress emerging from the pandemic to prevent such devastation happening again. CEPI’s five-year plan for 2022-2026 – known as CEPI 2.0 - aims to dramatically reduce or even eliminate the future risk of pandemics and epidemics. Central to the plan is CEPI’s goal to accelerate the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. Achieving this ‘100 Days Mission’, which has been embraced by the G7 and G20, would give the world a fighting chance of containing a future outbreak before it can spread to become a global pandemic, potentially averting millions of deaths and trillions of dollars in economic damage.
CEPI is a not-for-profit association under Norwegian Law and has offices in Oslo (HQ), London, and Washington DC.
In CEPI we strive for diverse thinking, and we want a diverse pool of candidates for all our vacancies. We work for an inclusive working environment where each employee can contribute and grow.
More details about CEPI and our mission can be found on our website: www.cepi.net
As COVID-19 has demonstrated, emerging infectious diseases represent an existential threat to our way of life. COVID-19 is not the first pandemic of the 21st century, and unless we act now, we can be sure that it will not be the last. Unlike some of the other big threats that humanity faces, we have the tools to systematically reduce and even eliminate the risk of future pandemics. It is vital that we capitalise on the rare alignment of political will, practical experience, and technical and scientific progress emerging from the pandemic to prevent such devastation happening again. CEPI’s five-year plan for 2022-2026 – known as CEPI 2.0 - aims to dramatically reduce or even eliminate the future risk of pandemics and epidemics. Central to the plan is CEPI’s goal to accelerate the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. Achieving this ‘100 Days Mission’, which has been embraced by the G7 and G20, would give the world a fighting chance of containing a future outbreak before it can spread to become a global pandemic, potentially averting millions of deaths and trillions of dollars in economic damage.
CEPI is a not-for-profit association under Norwegian Law and has offices in Oslo (HQ), London, and Washington DC.
In CEPI we strive for diverse thinking, and we want a diverse pool of candidates for all our vacancies. We work for an inclusive working environment where each employee can contribute and grow.
More details about CEPI and our mission can be found on our website: www.cepi.net
About the role
The primary role of CEPI’s Vaccine Development team is to provide the technical leadership to advance our vaccine portfolio, working closely with vaccine developers, CEPI’s Research & Development functions, cross-cutting Enabling Science teams as well as other internal and external partners, including WHO and vaccine industry networks IFPMA and DCVMN networks.
The post-holder will report to the Head of Clinical Development Science and will be a subject-matter expert in vaccines development and clinical science, 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. S/he will be responsible for facilitating CEPI-funded projects in a manner that guarantees clear communication and project continuity in adherence to CEPI guidelines and governance and which ensures compliance with national and international regulations and current ICH GCP guidelines.
The successful candidate will support the development of innovative clinical scientific and strategic concepts related to outbreak preparedness and in rapid response across the vaccine development cycle in support of CEPI programmes and objectives. These include vaccine libraries and prototype vaccines, rapid response vaccine platform technologies, broadly protective beta-coronavirus vaccines, and the “100 days” mission (www.cepi.net).
We are seeking an individual with a strong product development and clinical science background in the pharmaceutical industry and / or the academic environment who can interact with research groups, and corresponding health and regulatory authorities, at a global and local level. Cultural awareness in working with different countries, including in low- and middle-income countries (LMICs), will be essential.
The post-holder will report to the Head of Clinical Development Science and will be a subject-matter expert in vaccines development and clinical science, 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. S/he will be responsible for facilitating CEPI-funded projects in a manner that guarantees clear communication and project continuity in adherence to CEPI guidelines and governance and which ensures compliance with national and international regulations and current ICH GCP guidelines.
The successful candidate will support the development of innovative clinical scientific and strategic concepts related to outbreak preparedness and in rapid response across the vaccine development cycle in support of CEPI programmes and objectives. These include vaccine libraries and prototype vaccines, rapid response vaccine platform technologies, broadly protective beta-coronavirus vaccines, and the “100 days” mission (www.cepi.net).
We are seeking an individual with a strong product development and clinical science background in the pharmaceutical industry and / or the academic environment who can interact with research groups, and corresponding health and regulatory authorities, at a global and local level. Cultural awareness in working with different countries, including in low- and middle-income countries (LMICs), will be essential.
Responsibilities
- Develop / review and optimise overall clinical development plans for CEPI-funded vaccine development programmes
- Develop / review mock-up protocols including innovative evidence generation concepts for the rapid implementation of vaccine clinical trials in outbreak and non-outbreak situations
- Support the implementation of accelerated immune response assessment strategies and explore translational immunology aspects towards vaccine efficacy and safety including Co P, surrogate markers, immunological characterisation of vaccine platforms etc.
- Develop scenarios for priority pathogen-specific vaccine evidence generation strategies based on assumptions related to epidemiology and in close collaboration with internal and external stakeholders
- Develop qualitative concepts to utilize AI&ML for toolbox capturing clinical trial data enabling data sharing to inform critical research gaps
- Ensure high quality clinical development support is provided to all vaccine clinical development projects in compliance with CEPI’s clinical trials policy, SOPs, regulations, and current ICH GCP guidelines
- Closely collaborate with all Clinical Development departmental areas (incl. Clinical Development Programmes & Operations as well as Vaccine Safety), R&D divisional areas (incl. Regulatory, Laboratory Research and Innovations, Programme and Innovative Technology and Epidemiology) as well as other divisions (incl. Manufacturing & Supply Chain, and Policy, Partnerships & Access) within CEPI
- Closely collaborate with the external scientific community and organisations (incl. but not limited to WHO, BMGF, Wellcome Trust, PATH, IVI, academia, CROs)
- Support the development and implementation of CEPI Calls for Proposals and contribute to related review and due diligence activities
- Represent CEPI at international scientific conferences and in meetings with external stakeholders, global organisations (e.g., WHO), as well as national authorities and regulators
- Support CEPI and the Clinical Development department / R&D division to develop concepts supporting the organisation’s future priorities and help build the capacities to achieve CEPI strategic goals (including participation in and contribution to cross-functional / cross-departmental activities)
Education, Experience and Competence
- Medical or biomedical science degree with specialist experience in clinical (vaccine) development and science with solid knowledge of product development and multi-national vaccine clinical trial designs or similar experience and qualifications
- A minimum of 5 years of vaccine R&D experience within academia or the pharmaceutical industry or public sector
- Indepth understanding of clinical research, interventional and observational study design and concepts (including burden-of-disease vaccine efficacy endpoints, bayesian statistics etc.), vaccine immunology, data analyses, interpretation, medical statistics and experience in interacting with regulators on clinical development plans
- International experience (ideally in LMICs) and ability to work in multinational teams
- Strong interpersonal skills, team player with ability to lead projects, culturally aware and able to interact with internal and external stakeholders (e.g. global regulators, academia, and industry partners)
- High level of personal integrity
- Excellent command of / highly proficient in spoken and written English
- Insight into and understanding of the global vaccine development and pandemic preparedness ecosystems, including WHO, would be a plus
- Additional capabilities to support CEPI’s global role, culture, and heterogeneous working environment including but not limited to for example bridging across diverse groups internally and externally, ability to ‘make things happen’, innovative mindset / ‘thinking out of the box’, ability to address complex problems / develop creative solutions and concepts, team player, open-mindedness, resilience, curiosity, agility
Travel and Location Requirements
- This position is based in the UK, US or Norway, other locations maybe considered.
- Travel to other countries &/or regions required as part of the role.
What we can offer you
- Experience in the international effort on developing vaccines against emerging infectious diseases and accelerating vaccine development response to outbreaks
- The opportunity to work together with leading internal and external experts on solutions for global challenges
- A diverse and inclusive working environment
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