Principle Scientist, PMed Operations

Company Overview:

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. Our R&D division is dedicated to discovering and delivering transformational vaccines and medicines that prevent and change the course of disease. We are leveraging cutting-edge science and technology to build a deeper understanding of patients, human biology, and disease mechanisms, transforming medical discovery. We are revolutionizing the way we conduct R&D by uniting science, technology, and talent to get ahead of disease together.

Job Description:

As Principle Scientist PMed Operations specialising in Scientific Operations (SciOps), you will provide operational expertise to consistently implement the operational delivery of biomarker strategies developed by Clinical Biomarker and Virology leads within clinical trials, ensuring audit readiness at all times. You will be responsible for ensuring the appropriate level of sample quality, defining corrective actions if necessary, and escalating issues when appropriate. In larger programs you may work closely with an assigned Associate Director of Operations to ensure that program-level operational strategy is deployed within assigned studies. This position can sit in the Upper Providence, Waltham or Stevenage UK location.

Key Responsibilities:

• Provide operational expertise to implement biomarker strategies within clinical trials, ensuring audit readiness.
• Ensure appropriate sample quality, define corrective actions for study issues, and escalate issues as necessary.
• Where assigned collaborate with an Associate Director Scientific Operations to deploy program-level operational strategies within assigned studies.
• Accountable for sample management strategy deployment or definition and manage key activities with laboratory partners, including technical qualification, sample analysis plans, validations, and analytical reports.
• Ensure all activities are completed within time, quality, and budget requirements, aligned with agreed sample management strategy.
• Provide regular study-level status updates for areas of accountability/responsibility to key stakeholders.
• Provide expert input into Clinical Trial documentation, including Protocols, Informed Consent Forms, data transfer agreements, lab manuals, and central lab specifications.
• Ensure alignment of biomarker outputs with Data Management, Biostatistics, and modeling/simulation requirements, and provide expert input into data transfer agreements.
• Work with Clinical Operations to draft Site Communications and Training Materials; train CRO and internal teams on sample collection/processing activities as required.
• Accountable for the identification, documentation, and management of risks within assigned projects, in collaboration with the associate director for the program.
• Contribute to functional process and system improvements to ensure operational excellence.
• Support Clinical Pharmacology or other activities as required.
• Foster a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels, by role modeling the GSK values.

Basic Qualifications:

• Bachelors degree in a science or health-related discipline.
• At least 1-year experience in clinical trial specimen management, including collection/processing of diverse sample types, laboratory management, LIMS, and project management.
• At least 1-year of clinical development process, GxP, and global regulatory requirements.

Preferred Qualifications:

• Doctoral degree, Masters degree, or equivalent experience.
• Demonstrated knowledge of global regulatory requirements and expectations for sample analysis, including sample exportation.
• Experience with validation and implementation of biomarkers.
• Excellent communication skills, interpersonal skills, and matrix working skills.
• Self-motivated with the ability to work independently, as well as a highly motivated team player with a proactive attitude and ability to interact effectively within a multi-disciplinary team, including internal and external technical and business experts.

Please visit GSK US Benefits Summary t o 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 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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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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