Summary
Quote
Overview
Work History
Education
Skills
Certification
Modalities
Timeline
Accomplishments
Software
Interests
Work Availability
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David Henry

Associate Director - Toxicology Study Monitor
Peterborough,Cambridgeshire

Summary

Dedicated regulatory toxicology in vivo study manager with history of meeting company goals, utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. Dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Quote

Don’t postpone joy until you’ve learned all your lessons. Joy is your lesson.
Alan Cohen

Overview

11
11
years of professional experience
10
10
years of post-secondary education
1
1
Certificate
2
2
Languages

Work History

Study Monitor

AstraZeneca
Melbourne, Melbourne Science Park, Hertfordshire
04.2019 - Current
  • Monitoring of in-life phases and deliver regulatory outsourced CRO reports of ~50 studies/year to internal stakeholders within specific time frames to support internal governance milestones and regulatory submissions.
  • Providing in vivo data to project teams
  • Assisting early discovery teams with in vivo study designs and aiding with outsourcing activities, by understanding biology of compounds and objectives of studies
  • Ensuring efficient study designs with pre-study meetings to provide project context to external SD's and allow contribution to study design with relevant compound information shared with CRO
  • Used Microsoft Word and other software tools to create slide decks and other communications (data visualizations) to update project teams.
  • Proved successful working within tight deadlines and fast-paced atmosphere for highly prioritized programs.
  • Demonstrated respect, friendliness and willingness to help wherever needed by supporting team/project members.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Led projects and analyzed data to identify opportunities for improvement - e.g. automated data dashboard of external data.
  • Developing collaborative relationships with key stakeholders at external CROs.

Study Director

Envigo
Huntingdon, Cambridgeshire, UK
01.2014 - 04.2019
  • Directed and managed successful commencement, day to day running, completion, reporting and archiving of studies for great number and classes of studies
  • Liaised with internal and external customers to ensure prompt and proper action on all aspects of study plans
  • Attended and, where appropriate, assist in key elements of work of assigned studies
  • Compiled high quality GLP data and reports for regulatory submissions

Licensed Animal Technician

Envigo
Huntingdon, Cambridgeshire
06.2011 - 01.2014
  • Developed good data recording skills by understanding GLP requirements and objectives of studies
  • Performed various licenced and non-licenced procedures on rodents, dogs, old world primates, minipigs and farm animals
  • Implemented good animal training and husbandry skills to obtain high quality animal data
  • Identified and understood clinical signs observed in relation to class of compounds
  • Prepared equipment and materials for use on studies, which provided good knowledge of procedures and equipment
  • Performed all procedures to GLP to ensure that studies were fully compliant
  • Increased customer satisfaction by resolving issues.
  • Maintained excellent attendance record, consistently arriving to work on time.
  • Identified issues, analyzed information and provided solutions to problems.
  • Developed team communications and information for meetings.

Education

Study Director Training Programme - Study Director Training

Envigo
Huntingdon
07.2014 - 12.2016

Diploma - Modules 1 To 3

Institute of Animal Technology
Envigo
06.2011 - 06.2014

Bachelor of Science - Animal And Agricultural Sciences

University of Pretoria
South Africa
01.2006 - 12.2010

Skills

Excellent Communication

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Certification

BTS ACT Toxicology Course

Modalities

  • Adeno-associated viruses
  • Viral vectors
  • HVP cell therapies
  • CAR T Cell therapies
  • Self-amplifying mRNA compounds
  • Small interfering mRNA compounds
  • Monoclonal antibodies
  • Antidrug conjugates
  • Small molecules
  • Vaccines

Timeline

BTS ACT Toxicology Course

10-2022

Study Monitor

AstraZeneca
04.2019 - Current

Study Director Training Programme - Study Director Training

Envigo
07.2014 - 12.2016

Study Director

Envigo
01.2014 - 04.2019

Licensed Animal Technician

Envigo
06.2011 - 01.2014

Diploma - Modules 1 To 3

Institute of Animal Technology
06.2011 - 06.2014

Bachelor of Science - Animal And Agricultural Sciences

University of Pretoria
01.2006 - 12.2010

Accomplishments

Pristima implementation - responsible for the implementation of a Data Capturing System


Wiseguyz Workshops - facilitated and conducted workshops during a company merger


Minipig Blood Sampling - investigated the minipig blood sampling procedures to improve sample quality and animal welfare


Developed and implemented an automatize dashboard for visualising in vivo data from external CRO's by identifying data to visualized, developing infrastructure of the visualizations, assessing improvements to the dashboard and brainstorming new functionality

Software

Microsoft Office

Microsoft Power BI

Spotfire

Interests

Trail Running

Field Hockey

Horticulture

Reading

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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David HenryAssociate Director - Toxicology Study Monitor