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Lead the development and execution of clinical quality strategy, ensure compliance with GCP/GLP/GVP standards, and manage audit programs. Provide oversight and support for GLP/non-clinical and clinical development, including quality improvement and risk management.

The Associate Director, Trial Optimization Lead will enhance patient and site engagement strategies for clinical trials, collaborating with various teams to optimize operations and ensure effective enrollment.

The successful candidate will develop translational models to guide drug optimization, participate in multidisciplinary teams, and support regulatory interactions.

Lead statistical efforts of clinical programs, oversee regulatory submissions, develop analysis plans, and manage CRO relationships while ensuring compliance with global standards.

The Associate Director or Director, Bioanalytical will lead bioanalytical projects, engaging with internal and external teams to ensure effective execution and compliance. Responsibilities include method development, data review, and collaboration with CROs.