Clinical Science Lead Rsv Oa

Il y a 3 mois


Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre
**Posted Date**: Sep 25 2024
**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**

1. 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, net-work with thought leaders and international agencies as needed.

2. 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.

3. 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 Science Lead to lead the Clinical Project Team.

4. 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

5. Provides support to Marketing/Business Development throughout product life cycle
- Provide medical support to Marketing/Business Development in order to achieve Company’s objectives

6. Show active follow-up the product-related Environment
- Collect scientific information and review GSK Vaccines project related documents and publications

**_ Why You_**:
**Basic Qualifications**
- MD or PhD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology
- 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.
- Working knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape.
- Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum.
- Strategic thinking skills and achievement oriented.
- Able to critically analyse information, identify strengths and weaknesses of ap



  • Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre **Posted Date**: Sep 24 2024 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...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Philadelphia **Posted Date**: Nov 8 2024 GSK’s success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre **Posted Date**: Oct 4 2024 **Job purpose**: As the Scientific Leader and an expert in clinical assays within the Vaccines Clinical Laboratory & Assay portfolio (VxCL&AP) to be: - The scientific and strategic lead in the development and maintenance of clinical assays to detect and quantify biomarkers. - An assay owner,...

  • Clinical R&d Leader

    Il y a 6 mois


    Wavre, Belgique Jefferson Wells Temps plein

    Location: **Wavre** **#22146** **Clinical R&D Leader** Brabant Wallon - Contracting Our partner is looking for a **Clinical R&D Leader **to join its team. This international company is well-known for its pharmaceuticals and vaccines. **Your responsibilities?** - Contribute to activities or components of a Clinical and Epidemiology Plan (CEP) as...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Mississauga Milverton Drive, UK - Hertfordshire - Stevenage, UK - London - New Oxford Street, Warsaw **Posted Date**: Nov 12 2024 GSK’s success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about...


  • Wavre, Belgique Parexel Temps plein

    Join the APEX CRA Program! Are you a recent graduate and do you have 1 year or less of clinical experience? Did you study in the life sciences/data sciences/data analytics/clinical/nursing area? The Accelerated Program of Education, Exposure, and Experience for CRAs (APEX CRA) provides foundational clinical research training - including project and system...


  • Wavre, Belgique Parexel Temps plein

    **Join the APEX CRA Program - currently hiring in the **Benelux** Region - Belgium OR Netherlands** **November 25th 2024 start date** Are you a recent graduate and do you have 1 year or less of clinical experience? Did you study in the life sciences/data sciences/data analytics/clinical/nursing area? The Accelerated Program of Education, Exposure, and...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, Canada - Ontario - Mississauga, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, Warsaw **Posted Date**: Sep 23 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, Mississauga, Stevenage, Upper Providence, Waltham, Warsaw Zwirki Wigury **Posted Date**: Oct 1 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre **Posted Date**: Nov 12 2024 As the Scientific Leader and an expert in clinical assays within the Vaccines Clinical Laboratory & Assay portfolio (VxCL&AP) to be: - The scientific and strategic lead in the development and maintenance of clinical assays to detect and quantify biomarkers. - An assay owner, responsible for the...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre, Italy - Siena **Posted Date**: Sep 6 2024 **_ Job purpose:_** ***: **Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so, this Medical Writing Asset Lead role could be an ideal opportunity to consider.**: ***: **As a Medical Writing Asset Lead, you will lead...

  • Local Delivery Lead

    Il y a 2 mois


    Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre **Posted Date**: Oct 1 2024 **Job Purpose**: Provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country or cluster of countries; across all therapy areas (Rx and Vx) to the required quality standards, GSK written standards,...


  • Wavre, Belgique Parexel Temps plein

    **We are currently looking for a Senior Clinical Research Associate (SCRA) to join our Clinical Operations Team in Belgium.** **This role can be office-based in Wavre or **decentralized** in Belgium.** **Your time here** At Parexel, the SCRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using...

  • Medical Advsior

    Il y a 3 mois


    Wavre, Belgique GSK Temps plein

    **Site Name**: Warsaw Rzymowskiego 53, Belgium-Wavre, GSK House, Poznan Grunwaldzka **Posted Date**: Sep 10 2024 The European Partnership Markets (PM) is one of the largest regional businesses in the two European regions, and operates as an innovative partnership business model across 16 markets within Central, Eastern and Southern Europe and the Baltics,...


  • Wavre, Belgique SGS Temps plein

    Company Description - SGS is the world’s leading inspection, verification, testing and certification company. We’re also the benchmark worldwide for quality and integrity. And that makes us very proud. This can only happen thanks to almost 100 000 colleagues worldwide, with more than 1750 employees in Belgium only. Our employees give 110% of themselves...


  • Wavre, Belgique AbbVie Temps plein

    **Company Description** **Job Description** Job purpose & objectives** The **field**-based role focuses on medical and scientific engagement with AbbVie stakeholders (including research and healthcare professionals, payers, and providers). The focus of this role is on **interacting** with, and supporting the needs of, **Tiered External Experts in...


  • Wavre, Belgique Parexel Temps plein

    Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre **Posted Date**: Nov 20 2024 Job purpose: To contribute to the implementation of experimental design and data interpretation required for development, validation, and maintenance of clinical assays. **Your responsibilities**: - You are responsible for the operational and technical management of assays, supporting one or...


  • Wavre, Belgique Abbott Laboratories Temps plein

    Abbott is recruiting a Medical Science Liaison (MSL) Benelux for our Diabetes Care division (ADC). The MSL provides scientific expert advice and guidance to key customers for ADC products & relevant therapeutic areas, including scientific exchange & professional development with key thought leaders / external experts and provides scientific affairs support...

  • Medical Data Reviewer

    Il y a 6 mois


    Wavre, Belgique Amaris Consulting Temps plein

    **Job description**: We are currently seeking a dedicated and experienced Medical Data Reviewer to join our team at Amaris Consulting. This role is designed for professionals with 2 to 7 years of experience, offering an Undetermined Duration Contract in Belgium. As a Medical Data Reviewer, you will play a pivotal role in ensuring the scientific consistency...