Job purpose

The Senior Director, Clinical Compliance & Training will provide GCP/ICH quality leadership and strategic development of quality initiatives, supporting a quality culture in the execution of Cytokinetics clinical development programs. This person will provide guidance and support forDevelopment Operations including oversight of clinical quality activities and ensure clinical trials are conducted in a manner compliant with SOPs, ICH/GCP/regulatory guidelines and company goals. 

Responsibilities

• Strategically lead the Clinical Compliance & Training function to deliver knowledge, training, oversight, guidance and support, to promote and maintain GCP compliance for the operation and execution of Cytokinetics clinical development programs.
• Be the SME for Development Operations personnel for issues relating to 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 personnel in Root Cause analyses and advises on content of CAPAs and audit/inspection responses
• Drive the design, development and execution of development and training programs to support process quality and inspection readiness
• Evaluate business unit needs to design, develop and implement annual training plans for Clinical Development departments
• Partner with Clinical Operations, Quality Assurance, Data Management, Biostatistics, Statistical Programming, Medical Science, Drug Safety and Pharmacovigilance, and Corporate Compliance to manage study-specific training and ensure adherence to GCP compliance execution
• Partner with Clinical Quality Assurance on remediation of quality issues related to clinical study conduct.  Act as a liaison with Clinical Quality Assurance to ensure coordination and communication of quality driven initiatives, to ensure alignment on compliance decisions and recommended actions implementation

Qualifications

• 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
• This position requires an onsite presence at South San Francisco- remote work not supported.