Senior Director, Clinical Trial Safety

Job Title: Senior Director Clinical Trial Safety

Are you ready to lead the charge in clinical trial safety As the Senior Director of Clinical Trial Safety at AstraZenecas Trial Safety Review Centre (TRISARC) youll be at the forefront of ensuring the integrity and accuracy of critical clinical data. TRISARC plays a pivotal role in the Clinical Data and Insights (CDI) organization providing firstline medical review to support highquality decisionmaking throughout the clinical trial lifecycle. Your leadership will drive the strategic development and continuous improvement of safety data review processes across all therapeutic business units ensuring AstraZeneca maintains its commitment to excellence in drug development.

Accountabilities

• Develop and execute the strategy and longterm vision for TRISARC including capabilities technology and processes.
• Lead the clinical and safety data review strategy ensuring delivery of highquality consistent services.
• Build strong partnerships with Therapeutic Area Heads and physician leaders to align TRISARC services with project needs.
• Oversee TRISARC personnel performance and development equipping them for comprehensive data evaluation.
• Design centralized clinical/safety data review processes to support GCP compliance and inspection readiness.
• Serve as a leader within Global Development Operations interacting with key stakeholders across AstraZeneca.
• Manage performance based on key performance indicators and ensure daytoday delivery and quality management.
• Communicate TRISARCs vision internally and externally serving as an ambassador for CDI/TRISARC.
• Align with Therapy Area Heads to standardize clinical/safety data review and drive continuous improvement.
• Ensure TRISARC remains inspectionready and accountable for resourcing training and performance of personnel.
• Foster a positive work environment promoting teamwork creativity and courageous leadership.

Essential Skills/Experience

• University degree in related discipline preferably in life science or equivalent
• Min 9 years of experience in biopharmaceutical industry preferably in clinical development
• Significant experience in medical/safety data review pharmacovigilance pharmacy or nursing
• Experience as line manager with a track record of developing direct reports in their professional growth
• Excellent understanding of the skills and knowledge required for the successful delivery of drug development project e.g. ICH/GCP
• Excellent knowledge of international regulations
• Expert stakeholder management skills on a functional and enterprise level
• Proven negotiation collaboration interpersonal problem solving and conflict resolution skills
• Risk management experience
• Experience leading change at the enterprise level
• Demonstrated success and delivery of results through leading global teams
• Demonstrated ability to influence broadly within and outside the organisation
• Demonstrated teamwork and ability to work collaboratively across a wide range of disciplines
• Demonstrated ability to challenge the status quo and promote motivation and empowerment of others in order to accomplish individual team and organizational objectives
• Positive approach to individual team and business changes perceived as opportunity to improve performance and add value to the business
• Excellent communication skills in both spoken and written English (including scientific and business language)

Desirable Skills/Experience

• International working experience
• MD PharmD or Nursing educational background is a definite asset

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca we are driven by our passion for science and our commitment to making a difference. We are fusing data and technology with scientific innovations to achieve breakthroughs that redefine whats possible. Our inclusive environment encourages collaboration across academia biotechs and industry to create swift impacts on disease. With opportunities for lifelong learning and career development we empower our team to explore new ways of handling complex diseases. Join us as we push the boundaries of science to deliver lifechanging medicines.

Ready to make an impact Apply now to join our team at AstraZeneca!

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 industryleading 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 nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.