Site Name: USA - Maryland - Rockville Posted Date: Jan 28 2022 Are you energized by an opportunity to accelerate and deliver a clinical data strategy that drives compliance and efficiency? If so, this Clinical Research and Development Lead (CRDL), CMV Vaccine role could be an exciting opportunity to explore. Our Vaccines scientists work in three global R&D centers, in Belgium, Italy, and the USA - and a fourth virtual R&D centers dedicated to mRNA technology. We are focused on discovering and developing novel vaccines across a range of pressing public health threats. Our efforts are concentrated on those possible vaccines which may offer significant improvements over existing options or target diseases for which no vaccines yet exist. Our approach is to make the most of our own expertise and experience, while at the same time forming complementary partnerships and alliances with others who bring different kinds of expertise. Our vision for the world, where everyone has access to the vaccines they need, depends on a steady supply of great ideas and brilliant science. We have much to offer and through collaboration we can achieve so much more. We currently have an opportunity for Clinical Research & Development Lead/Clinical Development Director to join our CMV team. Reporting to the Clinical and Epidemiology Research & Development Project Lead (CEPL) you will conduct Phase I-IV Clinical Development activities within our accelerated CMV Vaccine 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 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… 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 (CEPL) in representing GSK Vaccines in meetings with health authorities and the scientific community, networking 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 CEPL or serve as delegate of the CEPL as the principal liaison to Internal Safety Review Committee (iSRC) and Independent Data Monitoring Committee (IDMC) and Firewall Teams (FWT). 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., CDC, NIH, ACIP/NITAGs, and other academia / government institutions etc…). 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 the CMV Vaccine program. Address scientific and medical issues related to one or more projects promptly. 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) as clinical program stakeholder. 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. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: MD or PhD Sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology / medicine development. 3+ years industry experience or minimum 10+ years of experience working in scientific or medical institutions (academic and/or government, including regulatory agencies). Experience in vaccines, clinical research, translational science, and biomedical research regulations, including ICH and GCP. Experience in the causes of infectious diseases, health interventions and the global public health landscape. Preferred Qualifications: If you have the following characteristics, it would be a plus: License to practice medicine (MD) and board and/ or professional certification Previous vaccinology and/or immunology experience Experience in leading or supporting a biologics license application or major sBLA Good theoretical and practical knowledge in clinical research. Ability to translate scientific skills in the field of vaccines and clinical research into business-driven strategies. Ability to work well within a matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organizational skills. Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence. 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 Why 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 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. *LI-GSK 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 Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. 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