Kenneth Sutton Email & Phone Number

Brentford, England, Gb

• Driving ViiV Healthcare clinical development programs through support of matrix study team.• HIV clinical development experience across phases 1-4• Accountable for the development, finalization, and amendments of study protocols with appropriate internal/external stakeholder input while ensuring protocol fulfills strategic objective of clinical development/ integrated evidence plan• Liaises with Medical, Commercial, and Asset Leads to ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursability where possible.• Provides scientific oversight of clinical studies, including assurance that data collection and study analysis plans are aligned with protocols, thereby allowing for intended scientific interpretation of study data and results.• Works with operations colleagues and matrix study team to ensure that all regulatory reporting requirements are met.• Co-ordinates with physicians and other study team members and stakeholders to enable appropriate review of safety data. Works closely with study physician(s) to help monitor safety and benefit/risk for studies.• Leads in generation of evidence and scientific outputs including content of investigator meeting, clinical study reports, preparation of study results for scientific meetings, congresses, and external journal publications, preparation regulatory documents, and other relevant study documents.• Partners with operations colleagues to ensure optimal delivery of study while maintaining close collaborations with other functions supporting the study.• Contributes to quality assurance and inspection readiness activities.

Brentford, England, Gb

Serve as a clinical investigation leader on global and regional teams.• HIV clinical development experience across phases I-III.• Create and foster strong strategic partnerships with colleagues that include others in Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, and Study Monitoring.• Lead the design, implementation, and interpretation of clinical trials.• Lead the writing of protocols, clinical study reports and regulatory-related documents.• Ensure trials are conducted effectively, reach target enrollment, and are conducted within budget- and time-constraints, in partnership with CROs and GSK regional and in-country groups, to deliver submission-quality data.• Demonstrate substantial and relevant knowledge of scientific and medical literature in HIV and its application to strategic design and operational achievements.• Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.• Proactively generate ideas for improvements and takes actions to solve problems and achieve goals beyond what is required. • Key skills include verbal and written communications, with the ability to present to internal department meetings and external investigator meetings.• Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP)

Brentford, Middlesex, Gb

• Serve as a clinical investigation leader on global and regional teams.• HIV clinical development experience across phases I-III.• Create and foster strong strategic partnerships with colleagues that include others in Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, and Study Monitoring.• Lead the design, implementation, and interpretation of clinical trials.• Lead the writing of protocols, clinical study reports and regulatory-related documents.• Ensure trials are conducted effectively, reach target enrollment, and are conducted within budget- and time-constraints, in partnership with CROs and GSK regional and in-country groups, to deliver submission-quality data.• Demonstrate substantial and relevant knowledge of scientific and medical literature in HIV and its application to strategic design and operational achievements.• Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.• Proactively generate ideas for improvements and takes actions to solve problems and achieve goals beyond what is required. • Key skills include verbal and written communications, with the ability to present to internal department meetings and external investigator meetings.• Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP)

Brentford, Middlesex, Gb

•Responsible for providing experimental and consultative data generation support for Genetics experimental projects, including recommendations on technology and platform, and the definition and implementation of the data QA/QC plan.•Responsible for providing technical expertise for DNA interrogation methods/platforms to the Genetics and Clinical organizations. This includes single and multiplex genotyping assays, WGS, HLA typing, Molecular Diagnostic and Next Generation Sequencing platforms•Accountable for the delivery of genotype or sequence data using external or internal platforms to support projects within Genetics. This may include assay design, primer ordering, assay validation, data generation, loading of internal and external data and quality assessment.•Accountable for maintaining knowledge of current and new genotyping technologies.•Accountable for the presentation of brief oral or written summaries of results with interpretation for Data Generation and Quality projects and activities.•Accountable for the maintenance of project related data in accordance with company policy and data integrity standards.•Manage matrix interactions and influencing with Sample Management and Data Management to seamlessly deliver genetic data with high integrity and quality.•Regular interface with TA Specialists, analysts, and other members of Genetics project teams.•Demonstration of excellent organizational skills and a great attention to detail. •Competent in planning and executing multiple tasks.•Strong emphasis on compliance aspects of Data Generation and Quality supporting GSK clinical trial studies and storage and access of human biological samples as a result of GSK HBSM policies.

Brentford, Middlesex, Gb

•US Genotyping Specialist for Genetics Division. •Ability to create and validate TaqMan and Amplifluor assays•Identify genetically associated targets for drug development.•Great working knowledge of the FAST assay, which utilizes a multiplex PCR coupled with single base chain extension (SBCE) to make genotyping more efficient and cost effective, TaqMan assay (Custom made or Assay on Demand), and Amplifluor assay. •Representative for Custom Genotyping on PGx Rapid Response team. •Ability to develop and implement procedures and protocols to improve efficiency and effectiveness.•Demonstration of full commitment to Safety principles and guidelines•Thorough operational knowledge of laboratory instrumentation, automation and computer based programs. •Awarded GR Star seven times for going beyond the call of duty and being a team player.•Awarded Exceptional Science Award for contributions to the scientific advancements of Alzheimer’s Disease

•Adhered to appropriate protocols and changes to protocols•Aided in the maintenance of the lab area, including replenishing of reagents, emptying of waste receptacles, and decontamination of lab equipment.•Surveyed work productivity throughout the week to make sure deadlines are met•Continued and mastered use of laboratory instrumentation and automation•Strong familiarity of the genotyping LIMS system and other software such as Genoportal, Spotfire, and JFASTGENO.•Strong communication with other groups in Discovery and Pipeline Genetics•Use of the FAST assay•ACC Staffing Advisory Board member•Two-time recipient of the “Atta Job” award for excellence in the workplace

Master'S Degree, Genetics

Bachelor Of Science (B.S.), Biology, General