Johnson & Johnson Careers
Clinical Immunology Manager
Requisition ID: 1805696334W
Janssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.
In our organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.
The Clinical Immunology department is responsible for the immunological evaluation of vaccine candidates in early and late phase clinical trials. In close collaboration with the Biomarker group and Clinical Development group, the Clinical Immunology department executes the immunological strategies and ensures the development, and validation of the required immunological assays as well as clinical sample analysis and data reporting. Typical assays to determine the immunogenicity of vaccines are the antibody ELISA, T cell ELISpot, Intracellular Cytokine Staining, and Virus Neutralization assays. The Clinical Immunology department, which operates under GCLP guidelines, offers Janssen Vaccines with services in scientific and operational excellence, with high standards of quality and compliance. Our laboratory capability is based in Leiden and allows us to operate on a mix model of in-sourcing and out-sourcing, depending on projects’ needs and internal strategies.
The Clinical Immunology manager’s main responsibility is to deliver key departmental support for the timely and successful execution of multiple vaccine programs from early phase to late phase trials, including post-marketing needs. He/ she leads a team with responsibilities for contracting, outsourcing, budget, demand vs supply analysis, process excellence in support of the departmental deliverables. As a member of the departmental leadership team you report directly to the head of department and you help create, execute and maintain the long-term vision of the department. As a team member, you engage others to find creative and practical solutions to resolve issues or conflict in resources. You pro-actively identify gaps and lead positive change for the department. You are active in developing out-sourcing strategies, in collaboration with Senior Scientists, Subject Matter Experts or Lab Operations to allow development/ validations of bio-assays and sample analysis in line with the needs of the department and evolving demands from the organization. You are also active in maintaining or strengthening collaborations with other key departments, such as Clinical Operations, Procurement, Clinical Development, Portfolio Management, Finance etc…. As a people leader, your role is to coach and empower your team to deliver quality and speed while fostering an environment of personal development. With the right knowledge/ experience, you may be involved in contributing or reviewing technical document (assay validation reports, SOPs) and support others in regulatory documentation writing.
- At least a Master and >8 years of relevant working experience in pharma, ideally with a focus on drug/ vaccine product development.
- Solid hands-on experience of pharma operations related to clinical research or trial execution, including late phase (post-marketing a plus).
- Experienced with:
- developing and executing active outsourcing strategies, establishing/ strengthening relationships with CRO.
- Cross-portfolio budgeting and demand vs supply forecasting.
- Scenario planning and risk mitigation strategies.
- Project management, with use of (visual) planning and project management tools such as Microsoft project.
- Excellent communication skills, fluent in English.
- Strong and proven experience in people management.
- Experienced in working under quality standards such as GCLP, GCP, GMP or similar.
- Solid experience with Lean and process excellence.
The right candidate is:
Tactful and proactive.
Able to remain and help others remaining calm and positive under pressure.
A team player with soft skills, able to motivate and empower.
A well-rounded leader, who can make decision, think strategically and communicate clearly/ diplomatically with stakeholders.
Capable of leveraging resource in cross-functional environment.
Able to influence in a diverse and multi-cultural organization.
Ability to generate impactful, visual and accurate presentations.
Able to work across complex projects and with partners to prioritize and find the right balance between supply and demand.
Independent thinker, and not afraid to challenge the status quo to find efficiencies.
Natural ability to connect with others and build trust.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset.
We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Janssen Vaccines & Prevention BV (8852)