The Global Center for Clinical Trial Safety Data Review (TRISARC) is a department in the Global Research & Development (R&D) function of AstraZeneca Warsaw. TRISARC team is responsible for the remote review of clinical data related mainly to safety flowing through the clinical trial environment to in order to ensure patient data is complete and medically accurate allowing efficient data interpretation in cooperation with study physicians and scientists. 

The Associate Director Clinical Trial Safety (ADCTS) is a management role within AstraZeneca Global Development Operations reporting directly the Head of the Global Center for Clinical Trial Safety Data Review (TRISARC). The role will combine the line management accountabilities and input to department management with expert collaboration with medics accountable for medical review of data collected in the process of clinical studies. The individual will lead and manage teams of Clinical Trial Safety Scientists and Specialists who are responsible for reviewing important clinical data related mainly to safety during clinical trials in R&D. The ADCTS must be science-driven individual with relevant therapeutic area experience (i.e. Oncology, Immuno-oncology, Respiratory, CVMD, etc.).

Typical Accountabilities

• Accountable for Clinical Trial Safety Scientists & Specialists performing the review of critical clinical data related to safety for medical completeness and medical accuracy
• Contribute to study start-up activities such as the generation of the Safety Management Plan and Safety Handling Plan
• Work collaboratively as a member of Global Development Operations
• Support the Director 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 to establish standards for review of important clinical data related to safety, quality metrics including aggregate safety reports and patient narratives
• Ensure and maintain appropriate training for self and staff, SOPs, and processes
• Ensure alignment with important functions involved with handling and interpretation of clinical data related to safety (Global Therapeutic Area, Data Management functions, Patient Safety) and appropriate training recommendations
• Ensure transfer of learnings between studies within the Therapeutic Area
• Accountable for the resourcing, training, and goal-setting, and performance management of TRISARC personnel assigned to the team

Requirements:

Essential:

• Medical or life science degree
• Minimum 8 years of experience working with clinical studies, pharmaceutical development, patient safety or pharmacovigilance across multiple therapeutic areas
• Experience as a line manager with a track record of developing direct reports in their professional growth
• Extensive knowledge of applicable regulations and guidelines related to clinical development
• Good level of medical knowledge in relevant therapeutic area (i.e. Oncology, Immuno-oncology, Respiratory, CVMD).
• Risk management experience
• Ability to manage change
• Excellent stakeholder management skills
• Creativity, innovation, 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
• Exhibit of AZ Values and Behaviours

Desirable :

• Experience using data review tools such as 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
• Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information
• Good understanding of clinical data flow
• Computer proficiency

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.