Clinical Operations Asset Lead - Infectious Disease

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - London - Brentford Posted Date: Jan 5 2022 Are you energized by the opportunity to partner with key leaders in global medical science to accelerate business performance across and drive global operational support? If so, this Clinical Operations Asset lead-Infectious Disease opportunity could be an ideal opportunity to explore. As the Clinical Operations Asset Lead-Infectious Disease, you will be accountable within Global Clinical and Study Delivery (GCSD) team for the operational delivery plan to execute the scientific strategy for an asset and associated studies, working in partnership with functional subject matter experts. Accountable for delivery of a program of studies in Infectious Diseases, and be key point of contact for portfolio leaders (e.g. Early Development Leaders, Medicine Development Leaders, and/or Project Physician Leaders, as appropriate). Contribution to the Clinical Development Plan (CDP) and the development of protocols that align to the CDP to ensure operational feasibility and consistency within the program. Leads resourcing discussions on behalf of Clinical Operations, making recommendations on strategy and endorse the vendor(s) for the program and studies in accordance with the Clinical Operations resourcing strategy & principles. Oversight of delivery quality by being the escalation point for the program in Clinical Operations, ensuring inspection readiness at all times and having regular interaction with Study Delivery Leads involved in the program such that they are aware of issues / risks / successes with study delivery as they occur. Models scenarios for optimal program/study delivery linked to value drivers and drives decisions for governance boards to optimise delivery with transparent implications to time, quality, risks and budget. Drives innovative approaches to study delivery through external facing advances in technology and sciences. Creation of strong strategic partnerships with colleagues that include Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring and pre-Clinical Development, to ensure consistent approaches to study delivery, data collection and reporting across a defined indication. Contribution of relevant knowledge of scientific and medical literature in the Infectious Diseases field to apply to operational goals. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in life sciences. 10 or more years of clinical operations experience. Experience supporting Infectious Disease clinical trials (in particular antibacterial indications, HIV). Experience in developing and writing study protocols, study procedure manuals, informed consent forms and clinical study reports. Experience applying study management global regulatory guidelines such as ICH/GCP. Experience working with investigators, external experts, Contract Research Organizations and vendors. Preferred Qualifications: If you have the following characteristics, it would be a plus: Infectious Disease expertise, such as uUTI; gonorrhea; HIV; COVID-19; etc Advanced degree (e.g. MS, PhD, PharmD). Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment. Excellent leadership skills. Excellent influencing and negotiation skills Ability to work independently and proactively and to take on leadership roles on cross-functional study teams. 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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