Scott Davenport

• Perform study conduct preparation procedures including creating data collection system protocols based on the study design of the written protocol, performs in vivo study procedures, plans and coordinates the study conduct following the study protocol, Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP) regulations, Environmental Health and Safety (EHS) standards, animal welfare regulations, and departmental policies/procedures.
• Responsible for assuring that all study data and materials are organized, data quality control review is completed, and prepares in-life data for archiving.
• Provides planning, study conduct expertise, and analysis to support data interpretation of toxicology studies in laboratory animals under the direction of Contributing Scientists, Drug Safety Team Leads (DSTLs), and Study Directors
• Coordinate the generation, compilation, quality control review and/or submission of SEND deliverables for internal or external (CRO) studies.

Study Director Responsibilities:

• Perform all regulatory responsibilities in compliance with applicable regulatory standards.
• Responsible for overall technical conduct of in vivo toxicology and/or safety studies, as well as for the overall interpretation of the studies as described in 21 CFR 58.33., while ensuring compliance with applicable SOPs and guidelines, and Animal Use Protocols.
• Responsible for communicating with the DSTL to understand study design, including variation from standardized protocol outlines.
• Decision-making responsibilities include:
• Final call on interpretation of study findings including overall study conclusion
• Major modification to study design (e.g. discontinuation, dose changes, etc.)
• Handling study deviations and amendments, and responses to MQA
• Responsible for dose selection in conjunction with the DSTL and Study Director Management
• Timely reporting of the study to agreed timelines and, on completion of the study, ensuring that all study materials are promptly archived.

• Responsible for laboratory-based GLP activities to support the goals of DSRD and WRD
• Responsible for evaluation of fetal specimens for morphological development in both Rat and Rabbit Embryo-Fetal Development Studies.

• Perform study conduct preparation procedures including creating data collection system protocols based on the study design of the written protocol, performs in vivo study procedures, plans and coordinates the study conduct following the study protocol, Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP) regulations, Environmental Health and Safety (EHS) standards, animal welfare regulations, and departmental policies/procedures.
• Responsible for assuring that all study data and materials are organized, data quality control review is completed, and prepares in-life data for archiving.
• Provides planning, study conduct expertise, and analysis to support data interpretation of toxicology studies in laboratory animals under the direction of Contributing Scientists, Drug Safety Team Leads (DSTLs), and Study Directors

· Coordinate the generation, compilation, quality control review and/or submission of SEND deliverables for internal or external (CRO) studies.

RESPONSIBILITIES:

• Conducted all phases of Ion Channel Q-Patch assay activities, data collection, analysis, tabulation, QC review, and participated in data interpretation
• Performed cell line maintenance on all cIPA cell lines.
• Participated in routine equipment maintenance and instrument and/or assay troubleshooting

RESPONSIBILITIES:

• Responsible for protocol development, design, conduct, data interpretation and reporting of exploratory, mechanistic and screening stem cell assays.
• Responsible for technical conduct of the study, as well as for the overall interpretation and predictive statistical modeling.

• Responsible for all phases of GLP study conduct, scheduling, protocol development, in-life animal room procedures (dosing, clinical signs, blood collection) as well as post-mortem lab procedures (c-section, necropsy both maternal and fetal. Fetal external, internal and skeletal examinations.
• Was responsible for producing DART study data through the Teratostat statistical program.
• Post-study work included drafting study reports and addressing Quality Assurance audit findings.

• Husbandry, dose administration and all in-life study activities on GLP Toxicology studies.