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GlaxoSmithKline Clinical Research & Development Lead (CRDL) Th HSV in Wavre, Belgium
Are you energized by an opportunity to accelerate and deliver a clinical data strategy that drives compliance and efficiency? If so, this Clinical Development Manager role could be an exciting opportunity to explore.
As a Clinical Development Manager, you will be responsible for directing the data quality and data management activities at the study level in support of GSK’s medicine development strategy for internally and externally resourced studies.
To participate to Phase I-IV Clinical Development activities within a program or group of related programs 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 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 and Epidemiology Research & Development Project Lead (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.
Analyze and interpret the results as a subject matter expert.
Supervise the study conduct, and serve as the accountable for the overall delivery of the clinical trial.
Assure that results meet the highest standards of quality and ethical conduct.
Support to Independent Data Monitoring Committee (IDMC).
Completes 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 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.
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 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), as applicable. In clinical studies, 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.
Supports internal process improvement activities and initiatives.
Liaise with the Regional Evidence Generation team to ensure alignment of clinical trial activities (includes but not limited to, scientific and medical issues as well as subjects safety).
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 and Epi Project Lead or Senior CRDL 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.
We are looking for professionals with these required skills to achieve our goals:
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)
If you have the following characteristics, it would be a plus:
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 analyze information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks.
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.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.
Managing individual and team performance.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Implementing change initiatives and leading change.
Sustaining energy and well-being, building resilience in teams
Continuously looking for opportunities to learn, build skills and share learning both internally and externally
Developing people and building a talent pipeline
Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation
Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally
Budgeting and forecasting, commercial and financial acumen.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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