Clinical Science Lead RSV OA

Job title:

Clinical Science Lead RSV OA

Company

GlaxoSmithKline

Job description

Job PurposeTo 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 Responsibilities1. 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.
• Analyse and interpret the results as a subject matter expert.
• 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.
• Liaise with the Global Clinical Delivery team to ensure alignment of clinical trial activities (includes but not limited to, scientific and medical issues as well as subjects safety).

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 YouBasic 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 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.

Preferred Qualifications

• MD or PhD specializing in the field of paediatrics, obstetrics and gynaecology
• License to practice medicine and board and/ or professional certification is an asset.

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.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our 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 thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Expected salary

Location

Waver, Waals Brabant

Job date

Sat, 28 Sep 2024 02:23:32 GMT

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