Senior Clinical Science Lead

il y a 1 mois

Wavre, Belgique GSK Temps plein

**Site Name**: USA - Maryland - Rockville, GSK House, Siena, Wavre

**Posted Date**: Feb 23 2023

Senior Clinical Science Lead (SCSL)

Reporting to the Clinical Research & Development Project Lead (CPL) you will conduct Phase I-IV Clinical Development activities within a large program or group of related programs or, for a mid-size program, to lead Clinical Development activities in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration.

**Key responsibilities**
- Where applicable, lead matrix teams, to author clinical development plans, design clinical trial protocols, and author clinical study reports and publications of high scientific, operational and ethical standards, ensuring consistency of data within program and across projects.
- Responsible for the clinical portion of file submission and its registration process, under the leadership and direction of the CPL.
- Bear primary responsibility and accountability for scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents, including the Investigator’s Brochure and the Clinical Study Report.
- Where applicable, support or act as the delegate of the Clinical Research & Development Project Lead in representing GSK Vaccines in meetings with health authorities and the scientific community, net-work with thought leaders and international agencies as needed
- If applicable, represent clinical development within Vaccine Commercialization Team (VCT), Discovery Performance Unit (DPU), Protocol Review Board (PRB), Toxicology Working Group (TWG), etc.
- If appropriate, support the CPL or serve as delegate of the CPL as the principal liaison to Independent Data Monitoring Committee (IDMC).
- Serves as a scientific and management reference for the project (internally/externally)
- Supports internal process improvement activities and initiatives involving coordination of multidisciplinary working team across departments (clinical, safety, regulatory) and maintains contacts with internal and external stakeholders (e.g., Brighton collaboration working group, CDC, and others).
- Assumes accountability for the medical/legal and human safety aspects of the clinical program
- 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 projects. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals.
- Liaise with safety and pharmacovigilance teams, and serve on SRT (Safety Review Team), on clinical program level accountable for. In clinical programs, together with PV analyze 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.
- Budget, resourcing and timing
- Supports the clinical team to consistently achieve high standards in attainment of project timelines in global programs.
- Interfaces with the PDL to ensure milestone realization and resource optimization.
- Supports or Leads the Clinical Project Team(s)
- Support or leads one Clinical Project team (matrix teams including, but not limited to, CSL’s, Science Writers, Biostatistics, Study Delivery Leads, and Study Data Managers) with a spirit of creativity and instills optimism and a can-do attitude.
- Consistently displays creative and innovative leadership skills while working in a matrix team.
- Provides support to Marketing/Business Development throughout product life cycle
- Contribute to the clinical components of "Due Diligence" and other clinical activities in support of Business Development as applicable.
- Provide medical support to Marketing in order to achieve Company’s objectives.
- Actively follows-up the product-related Environment
- Responsible for follow-up of project related literature, discussions with external experts and authors, participation in congresses and presenting GSK data.
- Reviews and approves labeling and related promotional materials where applicable.
- Contributes to provide leadership, direction and vision for the team.
- Provides input and participate in the recruitment and development of the team of Clinical Research & Development Leads.
- Build and foster the establishment of a CSL community.
- Serves as mentor in line / matrix reporting setting with an active interest in the leadership and technical development of team members.

**Basic Qualifications**
- MD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology.
- Minimum 3 years industry experience or minimum 10 years of experience

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