Are YOU energized by an opportunity to accelerate and deliver a clinical data strategy that drives the opportunity to protect people from infectious diseases? If so, this Clinical Research & Development Lead role could be an exciting opportunity to explore.As a Clinical Research & Development Lead, you will 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).This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:1. 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 full accountability to Clinical and Epidemiology Research & Development Project Lead.2. Bear primary responsibility and accountability for scientific, medical quality, medical/legal and human safety aspects and timeliness of clinical trial synopses and protocols and all clinical trial documents, including the Investigator’s Brochure and the Clinical Study Report. 3. Supervise the study conduct and serve as the accountable for the overall delivery of the clinical trial, analyze and interpret the results as a subject matter expert and assure that results meet the highest standards of quality and ethical conduct. 4. Serve as a scientific and management reference for the project (internally/externally), assuming accountability for the medical/legal and human safety aspects of the clinical study 5. As a member of the Clinical Project Team, always actively participate and engage within the project matrix, to achieve team objectives 6. Actively participate in preparing the clinical portion of the regulatory files and the registration process, including labelling 7. Provides support to Marketing/Business Development throughout product life cycle in order to achieve Company’s objectives8.Collect scientific information and review GSK Vaccines project related documents and publications.Why YOU?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:MD or PhD specializing in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, or pharmacoepidemiology. Previous experience in clinical vaccinology is an asset.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)Excellent knowledge of spoken and written EnglishAbility to translate scientific skills in the field of vaccines and clinical research into business-driven strategies.Understanding of GCP and ICH guidelines; experience working with Regulatory functions a plus.Ability to work well within a matrix environment, balance priorities, and independently handle multiple tasks through good planning, project administration, organization skills.Ability to critically analyze information, identify strengths and weaknesses of approaches and proactively develop remedial actions to mitigate risks.Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence.Knowledge and understanding of vaccines, clinical research, and biomedical research regulation · Preferred Qualifications:If you have the following characteristics, it would be a plus:Strategic thinking skills and achievement oriented.Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences.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 spectrumLicense to practice medicine and board and/ or professional certification is an assetWhy GSK?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 teamsContinuously looking for opportunities to learn, build skills and share learning both internally and externallyDeveloping people and building a talent pipelineTranslating strategy into action - a compelling narrative, motivating others, setting objectives and delegationBuilding strong relationships and collaboration, managing trusted stakeholder relationships internally and externallyBudgeting and forecasting, commercial and financial acumen.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or 1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.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.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.Full time
