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Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.
Position Summary
This role within Global Clinical Oncology R&D will serve as a clinical sciences leader on global oncology studies and contribute to program-level activities. Responsible for the delivery of quality study strategy and design, understanding the analysis and interpretation of data throughout the study, including leading clinical data review ongoing throughout study conduct. Responsible for the end to end of writing protocols (protocol concept to final study report) delivery. Contributor to informed consent forms development and other study related documents.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Review and/or enhance the technical and scientific robustness of project level clinical development plans.
May support regulatory interactions, including contributing to briefing documents, presentations, addressing questions and responses.
Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
Contribute to development of end-to-end clinical development strategy.
Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review.
Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
Participate in blinded review of data packages intended for IDMCs
Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
Actively partner to build relationships and collaborate with oncology aligned staff in other global functions.
Responsible for cultivating strong relationships and robust communication among the clinical study/project team and GSK’s
Oncology Clinical Development Organization. This includes training, education, onboarding as well as problem solving in the conduct of clinical trials.
Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
Study design and interpretation of study results that provide data to adequately address questions concerning efficacy/effectiveness, safety, applicability to targeted patient population, and clinical and commercial value that are consistent with the compounds’ phase of development while ensuring that patient safety is of paramount concern and that regulatory requirements are incorporated through:
1. Accountability for Study Team members/stakeholders, as appropriate and regulatory reporting at the study level by providing leadership at study level to assure overall safety of the study subjects.
2. Drive/Contributing to clinical components of the IB, and documents for regulatory submissions and advisory requirement, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents.
3. Serving as a product, protocol and project subject matter expert to support internal and external customers.
4. Working with external experts to develop abstracts, manuscripts and study design presentations.
Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals
Bachelor’s degree in life sciences or related discipline
3+ years of experience in pharmaceutical/biotechnology industry or related clinical experience
Experience in a pharmaceutical industry or CRO environment in the clinical development process
Oncology clinical development experience, particularly in the area of immuno-oncology
In depth experience with 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, site staff, external experts, Contract Research Organizations and vendors
Preferred Qualification
If you have the following characteristics, it would be a plus
Advanced degree (MS, PharmD, PhD) or equivalent clinical research experience. Clinical development experience across all phases of development (I-IV).
Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
Excellent influencing and negotiation skills
Excellent leadership skills
#GSK-LI
Skills
Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Cross-Departmental Collaboration, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Scientific Presentations
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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