Samantha Hornby, Pmp Email & Phone Number

United States

Groton, CT

• Developed and conducted biology strategy for diabetes / obesity drug discovery from chemical discovery through to human studies in a rapidly changing knowledge area with aggressive development timelines.
• Developed novel in vivo models to establish translational strategies, target selection, and predictive biomarkers for future clinical evaluation.
• Provided experimental design, study conduct, and data interpretation resulting in project advancement and scientific publication.
• Initiated and developed standardized data analysis templates to reduce analysis and reporting time by 70%, while also increasing data accessibility.
• Managed multiple projects, in tandem, to meet aggressive goals under tight timelines.
• Trained and mentored team of 15 scientists in the use of electronic data capture system as well as a variety of in vivo methodologies and surgical techniques.

Groton, CT

• Developed, and conducted CNS behavioral studies required for regulatory submission.
• Recognized as toxicology subject matter expert on cross-functional drug discovery teams, ensuring safety issues were identified and risk assessments conducted in a timely manner, to support project development.
• Developed in vivo drug withdrawal model to provide assessment of drug dependency risks for novel mechanisms under development.
• Delivered regulatory studies including experimental design, production of study protocols, data interpretation and analysis, presentation of results, and production of reports / publications to GLP guidelines.

Sandwich, UK

• Drug discovery and clinical development support using in vivo models within the Sexual Health TA. Responsibilities included coordination of a Sexual Health in vivo team, project definition, project conduct, and.
• Supervised a team of 5 in vivo scientists performing a range of pre-clinical models including evaluation of personal and scientific development needs of team members.
• Conducted in vivo models, including large and small animal surgery, investigating cardiovascular safety and erectile effects of both novel pharmaceuticals and marketed products to generate critical data for candidate.
• Chaired a forum of 20 scientists to increase the understanding of the physiology and pathophysiology of sexual function / dysfunction.
• Delivered studies including experimental design, production of study protocols, data interpretation and analysis, presentation of results, and production of reports / publications.

Bothell, WA

• In vivo evaluation of medical devices, bone induction agents, and novel pharmaceuticals, in a wide range of models. The role included responsibility for project definition, project conduct, presentation and.
• Liaised with study sponsors to establish contractual arrangements, protocol content, and project results to ensure productive cost effective study.
• Managed interactions with internal Technical Service providers to ensure high levels of technical excellence.
• Monitored study compliance with GLP and ISO9001 quality assurance guidelines, and responded to internal and sponsor quality assurance audits.
• Performed technical procedures including dosing, surgical procedures, biochemical analysis, histomorphometric analysis, histological evaluation, and biomechanical testing.

• In vivo evaluation of medical devices, bone induction agents, and novel pharmaceuticals in a wide range of in vivo models. The role included responsibility for project definition, project conduct, and.
• Production of study protocols, interpretation and analysis and production of reports/publications.
• Liaison with Technical Services groups, and ensuring high levels of technical excellence.
• Ensuring GLP and ISO9001 quality assurance compliance within the studies, and responding to internal and Sponsor quality assurance audits.
• Discussions with Sponsors involving contractual arrangements, protocol content, and project results.
• Performing technical procedures including dosing, sterile procedures, bone scanning techniques e.g. pQCT and DEXA, biochemical analysis, histomorphometric analysis, histological evaluation, and biomechanical testing.

Responsibilities included staff allocation, ordering of supplies, record keeping, and experimental procedures.

Responsibilities included experimental procedures, animal husbandry, record keeping, and staff allocation in a GLP environment.

Bsc (Hons), Biological Sciences

O Higher National Certificate Science (Animal Technology)

Biomaterials And Biocompatibility

Single MS module completed