Clinical Scientist/Director, HBV

Site Name: Upper Providence, Waltham Posted Date: May 9 2022 At GSK, we're uniting science, talent and technology, to get ahead of disease together. We have a clear ambition of delivering human health impact in areas of major global health issues - like hepatitis B. Bringing your clinical development experience in hepatitis B or liver disease, you'll thrive in an environment where innovation and patient focus work hand in hand. As the Clinical Development Director - Hepatitis B, you will support the Clinical Development Director (CDL) & clinical team to develop clinical program and integrate pivotal studies, including combination trials for treatment of chronic HBV, as well as overall life cycle management plans. Job purpose and key responsibilities: Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for asset(s) in development Ensuring alignment with and support to project strategic plans, regulatory requirements and commercial goals, optimizing clinical study design aligned with IEP and CDP Generating the data and evidence required to determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics. Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members Actively contributing or leading the end-to-end clinical development strategy for a drug or program. Manages specific clinical development plans for product(s) and/or indication(s) in assigned therapy disease area Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs and align to business strategy and address patient needs Gathering and supporting the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile. Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery Why you? Basic Qualifications: Bachelor's degree in a science related field Significant experience in HBV clinical drug development with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options Significant clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication. Robust knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s) Demonstrated experience using new learning and digital tools to create innovation in other areas Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules Demonstrated experience integrating genetic data to inform and guide clinical protocols Proven ability to utilize statistics, and visualization techniques to interpret or analyze complex information and make correct inferences and conclusions. Preferred Qualifications: MD, PhD or PharmD degree valuable but not required Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance Closing date for applications: 31st May 2022 #LI-GSK #LI-hybrid Why GSK? At GSK, we want to find new medicines and vaccines in ways that are faster, more effective and more predictable. We start with what matters most, the science. Our approach to R&D focuses on science related to the immune system, the use of human genetics, and advanced technologies. Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including oncology, infectious diseases, immunology / respiratory and HIV. We have pivotal study starts in 2021 for our RSV vaccine in older adults, COVID-19 assets, long-acting anti-IL-5 antagonist, daprodustat, and dostarlimab. In oncology, momentum is building with 15 potential medicines in trials, including nine immuno-oncology and three cell therapies. We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do most good. If a project doesn't pan out, we take what we've learned and apply it elsewhere. Technology can help us find patterns in genetic data better and faster. We're using machine learning to unlock the potential of complex genetic data with new levels of speed, precision, and scale. And we're one of the first biopharmaceutical companies to have created an in-house AI lab dedicated to drug development. Even with the knowledge, tools, and resources within GSK, there's always a benefit to new perspectives. That's why we're increasingly partnering with and hiring outstanding people from cutting edge fields like tech, data-science and academia. In 2018, GSK formed an exclusive, highly innovative collaboration with 23andMe, the world's leading consumer genetics and research company. Other partners include: the Altius Institute; the UK Biobank, which is generating anonymized genetic sequence data from 500,000 volunteers; and the Open Targets Consortium, the mindset and approach of smaller, more agile startups. Find out more: Our approach to R&D. As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. 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