Senior Project Physician

hace 2 meses

Madrid, España GSK A tiempo completo

**Site Name**: Italy - Siena, Belgium-Wavre, GSK House, GSK Tres Cantos, Madrid, UK - Hertfordshire - Stevenage

**Posted Date**: Aug 8 2023

**Senior Project Physician**

Are you interested in a highly visible, highly impactful role that allows you to make significant contributions to the development of vaccines against diseases of global health importance?

A pivotal role in leading clinical development of specific projects in GVGH and the implementation of project-specific activities in the clinical development/drug safety area of vaccine development while partnering with internal and external senior stakeholders? If so, this role is an exciting move to explore.

**Job Purpose**:
The Senior Project Physician will lead Clinical Development of one or more GVGH Vaccine Development Programmes through the design and set-up of GVGH-managed clinical trials.

This role has medical monitoring responsibility for clinical trials of GVGH vaccine project(s), and will serve as lead author or key contributor of clinical plans and clinical trial documents (e.g., clinical trial protocols, reports and publications, integrated clinical documents for regulatory submissions etc.).

**Key Responsibilities**:

- Work in a Clinical Development sub-team of clinical and regulatory colleagues (clinical development, clinical operations, biostatistics & regulatory associates), and in collaboration with non-CD&RA members of the GVGH Project Team(s), with the responsibility to author clinical development plans, design clinical trial protocols, write Investigator Brochures, clinical study reports and publications of the project(s).
- Address scientific and medical issues related to trials of the project(s) in GVGH and be responsible for Medical Data Listing review, ensuring medical consistency within trial and across trials within the project.
- As a member of the Safety Review Team be responsible for medical assessment of serious adverse events, adverse events of special interest (AESI’s) and other events occurring during clinical trials and pay attention to potential safety signals. Additionally, participate in individual case safety report compliance activities and take the necessary corrective actions.
- Handling and/or coordinating studies with human biological samples using GVGH WS/GSK policies
- Support the Senior project physician Lead by representing GVGH in meetings with health authorities and the scientific community, network with thought leaders and international agencies, on specific projects GVGH vaccines related matters.
- Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within one or more programs
- Contribute to creation, review and revision of standards (e.g., SOPs, Work Instructions) on clinical development, regulatory and drug safety activities.
- Maintain/expand knowledge in vaccines, clinical trial methodology, and drug safety competencies including national and international regulations and Global Safety policies/procedures.
- Serve as the principal liaison to GVGH Safety and Data Management Committees: Internal Safety Review Committee (ISRC) and Independent Data Monitoring Committee (IDMC).
- Where applicable, lead matrix team, to author clinical development plans, design clinical trial protocols, and author clinical study reports and publications of high scientific, operational and ethical standards. Ensure consistency of data within program and across projects. Reporting accountability will be to the Senior Project Physician Lead

**Budget, resourcing and timing**
- Supports the clinical team to consistently achieve high standards in attainment of project timelines in global programs.
- Interfaces with the SDL to ensure milestone realization and resource optimization.

**_ Why You?_**:
**Basic Qualifications**:

- Doctor of Medicine
- 3+ years of experience in clinical development and/or drug safety within the industry, or 10 years working in a scientific or medical Institution.
- Experience in designing and implementing clinical development plans
- Experience in managing multiple clinical trials running concurrently
- Ability to translate scientific skills in the fields of clinical research into business-driven strategies.
- Experience working in a matrix organization with an ability to influence key stakeholders.
- Innovative problem solving is a desirable requirement due to the need to provide a balanced clinical and ethical guidance, particularly in the poorly regulated countries where some of the GVGH clinical trials may take place

**Preferred Qualifications**:

- Doctor of Medicine with advanced university degree (Masters or PhD) and Board certification in Vaccinology, Infectious Diseases, Global Health, or Paediatrics.
- Experience as a physician in developing countries (e.g., Africa and/or Asia) is considered a very important added value.
- Experience managing vaccine clinical trials is a

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