Senior Director - Clinical Compliance and Training

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Cytokinetics

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Description

• The Senior Director, Clinical Compliance & Training will provide GCP/ICH quality leadership and strategic development of quality initiatives • Lead the Clinical Compliance & Training function to promote and maintain GCP compliance for clinical development programs • Be the SME for Development Operations personnel for GCP, non-compliance surveillance, Quality Events, audit/inspection responses and process optimization • Track quality issues, deviations, and corrective actions ensuring effectiveness and delivery • Partner with Development Operations in Root Cause analyses and CAPAs • Drive design, development and execution of training programs for process quality and inspection readiness • Evaluate business unit needs for annual training plans for Clinical Development departments • Manage study-specific training in collaboration with various departments

Requirements

• ICH/GCP expert with a strong understanding of FDA and EMEA regulations related to clinical development • BA/BS in science-related field. 15+ years’ work experience including Clinical Operations and Quality Assurance • Highly experienced as a Trainer, Training Facilitator or similar role • Advanced experience coordinating training events in a corporate setting • Adequate knowledge of learning management systems and web delivery tools • Excellent communication skills (verbal and written), including interpersonal skills with demonstrated successful team participation • Experience in Root Cause Analysis methodologies and CAPA management • Experience in supporting clinical trial GCP compliance/quality management activities and initiative • Strong understanding of drug development and clinical trial execution including cross functional areas involved in clinical trials • Experience in supporting GCP inspection readiness activities and participated in regulatory authority inspections • Strong leadership abilities to inspire and motivate others to achieve results • Strong analytical and problem-solving skills, with the ability to collect and analyze data to inform talent management decisions • Exceptional organizational and project management skills, with the ability to manage multiple priorities and meet deadlines • Ability to adapt to a fast-paced and changing environment and drive change within the organization