Director, Clinical Trial Safety TRISARC
Clinical Data and Insights is a function within Development Operations. We work across the R&D portfolio and lead the delivery of clinical data and insights, through simplification, quality by design and collaboration. Our scope includes data management, centralized monitoring, trial safety review, standards, automation & specialized programming, developing data capability and operations. Our vision is to transform our clinical data flows and advance data derived insights, to enable acceleration of life changing medicines to patients.
The Global Center for Clinical Trial Safety Data Review (TRISARC) is a department in the Clinical Data and Insight within Development Operations function of AstraZeneca. The primary remit of the TRISARC is to review large amounts of safety data flowing through the clinical trial environment in order to ensure patient data is complete and medically accurate thus allowing study physicians and scientists to interpret safety data efficiently.
The Director Clinical Trial Safety (DCTS) is a management role within AstraZeneca Development Operations in R&D reporting directly the Senior Director of the Global Center for Clinical Trial Safety Data Review (TRISARC). The individual will lead and manage teams of Clinical Trial Safety Associate Director Scientists, Senior Scientists, Scientists who are responsible for reviewing important safety data during the course of late stage global clinical trials. The DCTS must be science-driven individual with relevant therapeutic area experience (i.e. Oncology, Respiratory& Immunology, CVRM, etc.).
Oversee the centralized safety data review processes and implementation of fit-for-purpose, GCP compliant data integrity and contribute to inspection readiness supporting the aspiration of zero critical findings from Development Operations activities.
Implements TRISARC department strategy, including capabilities, technology and processes.
Ensure day-to-day team delivery, maintenance, quality management, improvement, and transformation of all standard practices, processes and technology utilized in the group
Accountable for Clinical Trial Safety Associate Director Scientists, Senior Scientists, Scientists
Performing the review of critical safety data for medical completeness and medical accuracy
Contribute to study start-up activities such as review and input into the Medical Oversight Plan
Work collaboratively as a member of TRISARC LT and Clinical Operations
Support the Senior Director of TRISARC to forecast resourcing, utilization, and functional budget
Assist with recruiting and retaining talent, including building effective teams and people that support and complement each other
Align with the respective Therapy Areas (R&D) to establish standards for important safety data review, quality metrics including aggregate safety reports and patient narratives
Ensure and maintain appropriate training for self and staff for relevant therapeutic area, Pharmacovigilance topics, SOPs, processes, systems
Ensure alignment with important functions involved with handling and interpretation of safety data (Patient Safety, Global Therapeutic Area, Data Management, Centralized Monitoring functions) and appropriate training recommendations
Ensure transfer of learnings between studies within the Therapeutic Area
Ensure assessment of service effectiveness is completed for closed and/or terminated studies
Accountable for the resourcing, training, and goal-setting, and performance management of TRISARC personnel assigned to the team
Accountable for Clinical Trial Safety Associate Director Scientists and Senior Scientists team authoring patient narratives
Education, Qualifications, Skills and Experience
University degree in life science discipline, preferably in medicine and experience in medical review, patient safety or pharmacovigilance preferably in relevant therapeutic area
Minimum 8 years of experience working on clinical studies and/or pharmaceutical development across multiple therapeutic areas
Clinical Operations experience within the therapy area of interest
Experience as a line manager with a track record of developing direct reports in their professional growth
Extensive knowledge of applicable regulations and guidelines, including SAE reporting requirements
Excellent stakeholder management skills
Good understanding of clinical data flow
Risk management experience
Ability to manage change and simplification the way of working
Creativity, innovation, strategic thinking and results-oriented
Ability to set and manage priorities, resources, performance targets, and project initiatives in a global environment
Excellent knowledge of spoken and written English
Experience using data review tools such as RAVE, JReview, JMP Clinical or Spotfire
Ability to develop advanced computer skills to increase efficiency in day to day tasks
Experience in medical writing and producing patient narratives
Proven organizational and analytical skills
Adept at building and leading presentations
Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to study delivery operational activities
Analytical skills, and ability to concisely summarize large amounts of complex information
Exhibit of AZ Values and Behaviours
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.