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This role involves leading the development and delivery of strategic life sciences partnerships for the South West Secure Data Environment (SWSDE). Responsibilities include building relationships with life science organizations, developing commercial models, and ensuring governance and ethical standards are maintained.
This role involves leading patient engagement initiatives in clinical research, ensuring patient perspectives shape clinical trial design and participant experiences. Responsibilities include advising study teams, building relationships with patient advocacy groups, and representing CSL externally to promote patient-centric research.
This role involves leading safety data review and pharmacovigilance activities within clinical trials, ensuring compliance with international regulations such as GxP. The individual will mentor team members, manage CAPAs, support regulatory inspections, and contribute to safety reporting and risk management. Key responsibilities include MedDRA coding, safety data analysis, and developing pharmacovigilance procedures to support global regulatory requirements.
This role focuses on end-to-end quality oversight of external vendors and suppliers involved in regulated R&D activities, ensuring compliance with GLP, GCP, GMP, and GVP standards. The individual will lead vendor qualification, audit management, quality agreement negotiation, and continuous performance monitoring, while collaborating with cross-functional teams including Clinical, CMC, Safety, and Legal. A key aspect is driving compliance, data integrity (ALCOA+), and continuous improvement across third-party partners through risk-based assessments, CAPA follow-up, and QMS integration.
This role involves leading strategic sourcing and evaluation of late-stage external Hematology therapeutic assets, engaging with key opinion leaders, and integrating innovation into portfolio planning. The position requires deep clinical expertise, a proven track record in deal-making, and strong collaboration with cross-functional teams.
