Clinical Science Lead
il y a 1 semaine
Site Name:
USA - Maryland - Rockville, Belgium-Wavre, GSK House, Italy - Siena, Netherlands - Amsterdam
Posted Date:
Jul 3 2023
Clinical Science Lead (CSL)
Job Purpose:
To conduct Phase I-IV Clinical Development activities within a program or group of related programs within the context of the GSK process in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and GSK standard operating procedures (SOP).
Key Responsibilities:
Participates in Clinical Development activities for a study or a number of studies within a specific program or group of related programs.
- 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 to Clinical Project Lead (CPL).
- Ultimate accountable end to end for any step of a clinical study, clinical trial synopses and protocols and all clinical trial documents, including the Investigator's Brochure and the Clinical Study Report
- Bear primary responsibility and accountability for scientific and medical quality of clinical studies.
- Assure that results meet the highest standards of quality and ethical conduct.
- Support to Independent Data Monitoring Committee (IDMC).
- Participate as core member to clinical study teams
- Complete tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience.
- Support where applicable the Clinical Project Lead in representing GSK in meetings with health authorities and the scientific community, network with thought leaders and international agencies as needed.
Serves as a scientific and management reference for the project (internally/externally)
- Assumes accountability for the medical/legal and human safety aspects of the clinical study. (If not an MD, assembles and transmits timely summaries of clinical safety data for review by competent medical officer).
- Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within program.
- Address scientific and medical issues related to one or more clinical studies. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals.
- Liaise with Safety to develop Risk Management Plans (RMPs), Global Safety Data sheets, Development Safety Updated reports (DSUR), and other aggregated periodic safety reports and serves on SRT (Safety Review Team), as applicable. In clinical studies, together with Safety analyse safety and potential signals and escalate accordingly.
- Publishes clinical data in peer review journals and presents in external scientific meetings / congresses.
- Maintains and expands knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology.
- Supports internal process improvement activities and initiatives.
As a member of the Clinical Project Team, always actively participate and engage within the project matrix.
- Actively participate as a core member of the clinical project team and contribute to achievement of team objectives.
- May be delegated by Clinical Project Lead or Senior Clinical Sciences Lead to lead the Clinical Project Team.
Actively participate in preparing the clinical portion of the regulatory files and the registration process
- Contribute to development of clinical section of regulatory files, including labelling.
Provides support to Marketing/Business Development throughout product life cycle
- Provide medical support to Marketing/Business Development in order to achieve Company's objectives.
Show active follow-up the product-related Environment
- Collect scientific information and review GSK Vaccines project related documents and publications.
Requirements:
Minimum Level of Education Required:
- MD or PhD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology.
Preferred Level of Education:
- MD or PhD specializing in the field of paediatrics, obstetrics and gynaecology, infectious diseases, clinical epidemiology, or pharmacoepidemiology. Previous experience in clinical vaccinology is an asset. Minimum 1 year industry experience or minimum 5 years experience working in a scientific or medical institution (if not an MD, prior experience as Principal Investigator, Medical Monitor or commensurate to Clinical Research Scientist position)
- Basic knowledge and understanding of vaccines, clinical research, and biomedical research regulation, including ICH and GCP.
- Wo
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