Clinical Development Lead

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 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

CEPI has recently launched a call for proposal for Innovations to Prepare for Future Epidemics and Pandemics to support CEPI’s mission by advancing a broad range of vaccine innovations for pathogens with epidemic or pandemic potential, including novel pathogens capable of infecting and causing disease in humans (i.e., Disease X). CEPI is seeking a Clinical Development Lead based in London, Oslo, or Washington DC to join its growing Vaccine Development team in support of this rolling call for Innovations. Further details regarding the role are included below.

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 Programmes and Operations and will be a subject-matter expert in vaccines development and clinical operations supporting the advancement of 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 review of strategic clinical development plans for vaccine programmes as well as conceptualise and advance operational plans for the rapid implementation of vaccine clinical trials. S/he will provide advice and support to the clinical development teams, considering pathogen-specific outbreak characteristics and epidemiology as well as trial logistics and site capabilities.

We are seeking an individual with a strong product development background who can interact with research groups, and corresponding health and regulatory authorities, at a global and local level in the preparation and implementation of vaccine clinical trials. Cultural awareness in working with different countries, including in low- and middle-income countries (LMICs), will be essential.

We are seeking an individual with extensive clinical development experience in the pharmaceutical industry and / or the academic environment who can interact with sponsors, trials sites, CROs, and research groups at a global and local level, as well as corresponding health and regulatory authorities. A good overview of the vaccine development ecosystem and cultural awareness of working with multiple partners, including in LMICs, are essential.

Responsibilities

• Support the project lead for the Innovations CfP in assessing and evaluating applications for funding, and in ongoing clinical support to the projects, in particular for the focus areas of: advancing innovative rapid-response vaccine platforms that can transform the response to a future Disease X, and developing new vaccine candidates against CEPI priority pathogens with epidemic or pandemic potential and viral families.
• Ensure high quality vaccine 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
• Identify and facilitate clinical operational cross-cutting activities across vaccine R&D projects and collaborations with internal and external partners and stakeholders
• Develop / review and optimise overall clinical development plans for CEPI-funded vaccine development programmes
• Ensure timely and accurate completion of key clinical project milestones and review clinical data for milestone decision processes
• Ensure clinical funding and resources are appropriate to successfully meet the operational requirements of the program
• Closely collaborate with the other Clin Dev. departmental areas (incl. Clinical Development Science as well as Vaccine Safety), R&D divisional areas (incl. Regulatory, Enabling Science, and Epidemiology) as well as other divisions (incl. CMC, Business Development) 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 function / R&D Department 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 delivery (planning and implementation) of multi-national vaccine clinical trials or similar experience and qualifications
• A minimum of 5 years of vaccine R&D experience in industry, contract research organisations (CROs) or public sector
• 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 global regulators, academia, and industry partners
• Experience in CEPI priority pathogens is highly desirable
• Experience in therapeutics/monoclonals is a must
• High level of personal integrity
• Understanding of project management strategies and tools is highly desirable
• Excellent command of / highly proficient in spoken and written English
• Familiarity with project management software / Salesforce 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 for the right candidate.
• 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

How to apply

• For more information on how to apply, please visit: https://cepisites.secure.force.com/careers
• Should you have any issues submitting your application or have questions please contact jobs@cepi.net
• Background verification will be conducted to verify information provided in the CV and available documentation for the successful candidate.
• Deadline for receiving applications is 18th March 2024 at 23:59 CET