Clinical Ai Informatics Jobs in California (NOW HIRING)

The Opportunity:

The Senior Director of Clinical Data Management (CDS OpsEx) provides high-level leadership for Data Management and functions within clinical development including Information Operations, Data Products, and Clinical Data systems, focusing on strategic development, operational execution and excellence, and regulatory compliance to ensure data integrity for clinical trials. Key responsibilities include leading and managing data management and cross-functional teams, establishing and enforcing data management policies and procedures, overseeing departmental budgets, collaborating with cross-functional stakeholders and vendors, and ensuring data management processes, systems and systems integrations meet regulatory standards. This role requires extensive experience in the clinical data management setting, strong leadership and communication skills, expertise in clinical trial methodologies and systems, and a deep understanding of regulatory requirements including submissions and data management systems.

Required Skills, Experience and Education:

• MS, BS/BA degree, or other suitable qualification with relevance to the field.

• 17 or more years' direct experience in clinical data management in the biotechnology OR Pharmaceutical industry.

• Help define and implement the overall vision, strategy, and goals for the clinical data management department, including developing and enforcing departmental SOPs, with a focus on data standards, systems, system integration and operational excellence and efficiency.

• Extensive experience in clinical data management processes and systems, with proven leadership experience in oncology therapeutic area.

• Proficient knowledge of EDC systems (e.g., Medidata Rave), CDISC standards, and clinical trial processes.

• Proven track record of developing and implementing clinical data standards and governance, with a focus on Oncology data standards.

• Automation and digital transformation initiatives to improve data quality and efficiency (e.g., IXRS, AI/ML tools, RBQM platforms, RSG implementation/E2B, in-house coding implementation, in-house CTMS development support, other clinical development systems implementation and integrations).

• Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency.

• Experience focused on people, process, technology, and cost optimization, with a strong emphasis on data standards, process simplification, AI-driven automation, and building high-performing teams while reducing costs.

• Demonstrated ability to lead, motivate, and develop teams.

• Lead, manage, and develop data management teams, handling resource planning, staff training, and performance reviews.

• Develop and monitor KPIs for data quality and operational performance.

• Manage relationships with Contract Research Organizations (CROs) and other data management vendor partners, ensuring they meet quality and performance standards.

• Forecast, manage, and provide oversight for departmental budgets, including internal and external expenditures.

• Ensure data integrity, quality, and compliance with regulatory requirements (e.g., FDA, ICH, GCPs) and internal company policies.

• Experience with global trials and regulatory submissions (FDA, EMA).

• In-depth understanding of industry standards related to clinical data management (e.g., medical dictionary coding).

• Guide data management activities for regulatory submissions and represent the department during regulatory inspections and internal audits.

• Serve as a key liaison and collaborate effectively with cross-functional teams (e.g., Clinical, Quality, Regulatory) and key external stakeholders.

• Excellent communication and interpersonal skills to effectively collaborate with diverse teams and stakeholders.

• Strong problem-solving and decision-making abilities to resolve complex issues and drive solutions.

Preferred Skills:

• A degree in life science, health informatics, or a related field.

• Exposure to real-world data (RWD) and decentralized trial models.

• Experience building psychological safety across the Clinical Data Management team, stakeholders and partners to foster collaboration, encourage open communication, and improve team performance.

• Experience developing a low-cost FSP model.

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