Clinical Development Associate Director - Open to flexible working
If you're looking to collaborate with world-class physicians and scientists and work in a culture that incentivizes courageous and smart risk-taking to help deliver the next generation of transformational medicines, this is the role for you!
- Contribute to study design, protocol development and in partnership with the Study Delivery Lead and Study Team, deliver clinical studies enabling key decision points and Go/No Go criteria for the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP)
- Support the delivery of clinical studies that generate high quality data and the evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patients in the shortest possible timeframe
- Develop and maintain relationships with program counterparts including Commercial, Research, Regulatory, Clinical Operations, Statistics and Value Evidence and Outcomes Research
- Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development
Scientific Leadership, Direction & Strategy
- Demonstrates ability to influence others at project, departmental and inter-departmental levels, as appropriate
- Gathers and supports the integration of inputs from across disciplines (e.g., scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile
- Awareness and appropriate escalation of data that could impact the risk/benefit profile of medicines
- For given indications, understand current treatment landscape, which symptoms and aspects of disease progression are well controlled and where current therapies and industry development pipeline products will impact quality of life of patients
- Provides scientific and operational consultation for existing program(s) and/or other clinical teams across R&D
Study & Program Design and Evidence Generation
- Contributes to development of end-to-end clinical development strategy ensuring consistency with the IEP and CDP to support regulatory approvals, reimbursable medicines, and successful lifecycle management
- May support regulatory interactions including contributing to briefing documents, presentations, addressing questions and responses
- Provides support of evidence generation activities to assure patient safety and study delivery
- Contributes to the awareness of the local healthcare environment and customer needs (providers, institutions, payers, patients, consumers
Creating Innovative Scientific and Technical Solutions
- Demonstrates creativity, intellectual curiosity and a growing interest in the use of digital tools to solve problems
- Embraces innovative improvements and takes actions to solve problems and achieve goals; suggests new ways to apply existing knowledge
Closing Date for Applications: 8th July 2022, COB
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application, you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
- Bachelor’s degree in a science related field and/or PharmD or PHD
- Experience of prior clinical training and/or relevant clinical development experience; good understanding of the overall clinical development process including planning and running clinical trials from concept study idea to publication
- An 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
- Knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area
- Developing leadership, influencing, collaboration skills; ability to take smart/calculated risks, excellent written and communication skills.
- Utilises inductive and deductive reasoning, data visualisation, and statistical methods to analyse information to answer questions or solve problems.
- Develops new ideas and solutions to specific issues and offer contrasting points of view in individual / group settings.
- Ability to respond with confidence to straightforward questions applying sound judgment.
- Awareness of the importance of work undertaken in support of the medicine vision and lifecycle management plan, contributing as required.
- Developing experience of managing projects and working collaboratively with multiple stakeholders.
- Ability to make decisions based on facts, common sense, and previous experience with the ability to explain the reasoning behind decisions.
- Excellent team player with a “can-do” approach with proven experience of developing and maintaining excellent working relationships and effective strong collaboration with cross-functional teams.
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.
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.
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. This ensures that all qualified applicants will receive equal consideration for employment without regard to 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.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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