Medical Leader Respiratory Diseases

☞ Johnson & Johnson

Ver: 170

Dia de atualização: 16-11-2025

Localização: Beerse Antwerp

Categoria: Saúde / Assistência Médica

Indústria: Information Technology Services Financial Services Hospital & Health Care

Posição: Associate

Tipo de empregos: Full-time

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Conteúdo do emprego

Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.
We are currently looking for a Medical Leader Respiratory Diseases.
In this role you will have responsibility for developing strategy, designing and completing clinical development programs, and proving medical leadership through full development. You will manage the cross-functional execution of the overall clinical development plan, to bring the compound up to registration by health authorities.
Your key responsibilities:
- Co-creates the design of clinical development programs in alignment with the therapeutic area strategy and compound strategy and ensures that clinical trials meet ethical and regulatory standards.
- Co-leads (together with operations leader) the clinical team responsible for implementing clinical trial programs within agreed upon timelines.
- Owns the Protocol Element Document and the risk benefit section of the ICF, and reviews & approves the Data Safety Monitoring Board (DSMB) protocol or charter, and the Statistical Analysis plan.
- Ensures review and interpretation of efficacy and safety data from clinical trials.
- Supervises and participates in report and scientific writing activities for designated protocols including clinical study reports, scientific abstracts, presentations and publications.
- Is responsible for the clinical component in key clinical and regulatory documents such as Compound Strategy documents, Investigator Brochures, Clinical Trial Applications, Summary documents, Risk Management Plans, Target Label, and regulatory responses.
- Establishes and maintains working relationships with clinical trial investigators, key opinion leaders, academicians.
- As a one of the key members of the Safety Management Team, supervises the continued safety assessment of the compound under development, and reviews related safety documents.
- Is a key contact point in the interactions with regulatory agencies on the above-mentioned matters.
- Ensures clinical and scientific awareness in area of expertise.
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Data limite: 31-12-2025

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