Senior Clinical Research Dev Lead-Shingrix
To conduct Phase I-IV Clinical Development activities within a large program or group of related programs (led by a Clinical and Epidemiology Research & Development Project Lead - CEPL) or, for a mid-size program, to lead Clinical Development activities within the context of the GSK Vaccines 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 Vaccines standard operating procedures (SOP).
Participate at a senior level in Clinical Development activities for a series of studies within a large program or group of related programs or, for a mid-size program, lead Clinical Development activities.
• 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 Clinical and Epidemiology Research & Development Project Lead (CEPL).
• Responsible for the clinical portion of file submission and its registration process, under the leadership and direction of the CEPL.
• 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 and Epidemiology 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 Development Team (VDT), Vaccine Commercial team (VCT), Discovery Performance Unit (DPU,) Protocol Review Board (PRB), Toxicology Working Group (TWG), etc.
• If appropriate, support the CEPL or serve as delegate of the CEPL 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. (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 projects. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals.
• Liaise with PV to develop Risk Management Plans (RMPs), Global Safety Data sheets, Development Safety Updated reports (DSUR), and Periodic Safety Updated Reports (PSUR) and serves on SRT (Safety Review Team), on clinical program level accountable for. In clinical programs, together with PV 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
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 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)
MD specializing in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, or pharmacoepidemiology. Previous experience in clinical vaccinology is an asset.
• Knowledge and understanding of vaccines, clinical research, translational science, and biomedical research regulation, including ICH and GCP.
• 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 approaches and develop remedial actions to mitigate risks.
• Ability to understand high level corporate and business objectives: rapid, flexible, innovative working and decision making.
• Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences .
• Excellent knowledge of spoken and written English.
• License to practice medicine and board and/ or professional certification is an asset.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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