Clinical and Epidemiology Excellence Lead
Site Name: USA - Maryland - Rockville Posted Date: May 12 2021 The Clinical and Epidemiology Excellence Lead (CEEL) is responsible for supporting the Head Clinical RDC in: Supporting operational strategy for implementation of projects assigned to the RDC Tracking of milestones, key performance indicators (KPIs) and deliverables to manage the performance of Clinical R&D with the RDC Support transversal clinical activities related to development of the GSK Self Amplifying RNA Platform, including aligning clinical/safety readouts and protocol design Support oversight of Clinical R&D budget within the RDC to manage prioritization and trade-offs Support of risk management, including issues which may be specific to a given RDC Support training needs of new clinical R&D staff Support engagement with both internal and external stakeholders who are integral to the study oversight (e.g. Independent Data Monitoring Committee (IDMC) and firewall teams (FWT) Management of process improvements, audit\inspection preparation and CAPAs Support transversal development and implementation of the clinical trial diversity (CTD) strategy for new development programs Support integration of Vaccine (Vx) and Pharma (Rx) through new One Development organization. Support to management of resources including assistance with recruiting, onboarding and career development of operational staff, as well as outsourcing and contracting to meet needs of RDC as needed This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Support to maintain overall oversight on Clinical RDC budget and resource allocation providing regular estimates and updates to Head Clinical RDC, that help to ensure that clinical teams are appropriately staffed Track milestones on projects, KPIs and deliverables for Clinical RDC to optimize RDC performance. Oversight and support risk management for Clinical RDC Contribute to development of standards and processes across Clinical RDC. Ensure that standards and processes are implemented globally throughout the Clinical RDC with a high level of compliance and quality. Track implementation of CAPAs assigned to Clinical RDC staff; coordinate and contribute to audits and inspections as appropriate Where appropriate, lead large process improvement and\or change management work streams, including cross-functional work streams, particularly when specific to a given RDC. Participate as core member in Steering Committees as appropriate, including the Clinical Epi Performance Committee (CEPC), the Issue Management Core Team (IMCT), Clinical Risk Management Board (CRMB) and Clinical Quality Council (CQC) . Plan, coordinate and execute training and mentoring of Clinical RDC newcomers Support the mapping of training materials that exist on clinical, epidemiology, vaccinology, immunology, and integrate this into Keep Growing Campus Conduct ongoing training and awareness for of clinical trial diversity initiatives for cross functional clinical teams Support recruitment optimization strategies at the study and asset level and oversee completion of CTD deliverables; Participate to Clinical RDC Leadership Team and track key deliverables Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree 10 plus years of work experience in vaccine clinical research Experience in clinical and/or epidemiological trial design, trial execution and operations Experience in project management skills, including using project management tools Preferred Qualifications: If you have the following characteristics, it would be a plus: Post Doc in Life Sciences Proven track record of managing simple or medium complex programmes. Sensitivity to the needs of diverse ethnic groups with the ability to build rapport across the spectrum. Excellent people and team management skills. 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. Executive capability with strategic planning & budget processes such as analytical thinking. Coalition-building and communication skills (both written and verbal) with high level of attention to detail, good organizational skills, and a proactive approach to problem solving. Excellent knowledge of spoken and written English. Understand business implication of trial design and execution Experience in resource and budget management 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. *This is a job description to aide in the job posting, but does not include all job evaluation details. *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. 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