Global Clinical Study Delivery Lead - Multiple Positions Available

Site Name: UK - London - Brentford, Belgium-Wavre, Canada - Ontario - Mississauga, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence, Warsaw Posted Date: Feb 13 2023 Please Note: We have multiple positions available in Canada (Mississauga/Ontario), USA (Collegeville, PA), UK (Brentford, Stevenage) & Poland (Warsaw). Due to the current COVID pandemic we are open to talent working virtually from home during this time, although the long-term intent is to be located close to the mentioned hub sites. Would you like to be part of GSK’s clinical development team, with an opportunity to drive and lead scientific innovation to deliver the next generation of transformational medicines for patients in areas of high unmet need? If so, this could be an excellent opportunity to explore. We have openings across a wide variety of therapy areas. Job Purpose and Key Responsibilities: This job within Global Clinical Delivery (GCD) combines end-to-end design, execution, and reporting of clinical trials with leadership in project teams and across matrix teams. Key attributes include scientific credibility, demonstrated ability to input to and influence studies/projects through scientific and operational expertise, and demonstrated excellence in stakeholder management. This job requires strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and ability to lead and drive change. Essential behaviours valued include continuous improvement and learning, effectiveness at building networks of partners and stakeholders, and ability to lead and inspire others. A track record of applying experience and judgement towards project decision-making, effective peer review, and shared learning is essential. Details: This position may contribute to individual studies in addition to project level activities, as appropriate, including responsibility and/or accountability for the set-up, coordination, execution and delivery of one or more studies, programs, or groups of programs from one or more therapy areas, specifically: the delivery and quality of all clinical studies from protocol concept to final study report and for the validity of all data originating from studies supporting their portfolio. reviewing and/or enhancing the technical and scientific robustness of clinical plans and studies developed by the key customers for their designated area, while inputting and influencing. compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies. Making decisions which balance risk/benefit with clear understanding of impact on project; takes action to mitigate risk where appropriate. Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills. Why you? BASIC QUALIFICATIONS: Bachelor’s degree in life sciences or neuroscience Extensive experience within the pharmaceutical industry or CRO environment in clinical operations Experience of leading study teams Experience in study management, global regulatory guidelines and ICH/GCP Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports. Experience working with investigators, external experts, Contract Research Organizations and vendors Broad understanding of the pharmaceutical industry and the clinical development process In depth knowledge of either study management or data management and knowledge of essential regulatory guidelines worldwide and GSK company policies. Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary Excellent influencing and negotiation skills. PREFERRED QUALIFICATIONS: Advanced degree in life science or related field (e.g., MS, PhD, PharmD) or equivalent experience Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams. Excellent leadership skills. Demonstrated experience leading matrix environment to deliver projects, develop clinical plans, and manage change Why GSK? R&D 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. At GSK, we have delivered unprecedented change over the past four years - to improve R&D productivity and performance, transform commercial execution and to strengthen our leadership and reshape our organisation. Now, we’re getting ready to deliver the most significant change to our company in over 20 years. We’re on track to separate and create two ambitious new companies in 2022: A new GSK with a leading portfolio of vaccines, specialty and general medicines, and R&D based on the science of the immune system and genetics; and a new world-leading consumer healthcare company built on brands and innovation and delivering better everyday health. With new ambition comes new purpose. GSK will unite science, talent, and technology to get ahead of disease together. We’ll be a company where outstanding people thrive, delivering strong, sustainable returns to our shareholders and with the power to improve the health of more than 2.5 billion people over the next 10 years. All of this depends on our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; where we are all accountable for our impact and supported to succeed; and where we do the right thing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. *LI-GSK GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels As you apply, we will ask you to share some personal information which is entirely voluntary. 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