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Senior Director, Clinical Data Management
Gilead Sciences - Santa Monica, CA
posted 2 months ago
About the position
The Senior Director, Clinical Data Management at Kite Pharma is a leadership role responsible for overseeing the Data Management function within the organization. This position involves strategic and tactical capabilities, focusing on excellence in business processes while managing a team of data management professionals. The role requires collaboration with various cross-functional leaders to ensure effective data management for clinical studies, including database programming, data collection, and regulatory guidance.
Responsibilities
- Oversee all aspects of the Data Management and Clinical Programming teams including resource planning, deliverables, staff training, staff appraisals, performance reviews, and annual salary reviews
- Develop Data Management Departmental SOPs and ensure staff adherence to company policies, SOPs, federal guidelines and GCPs
- Forecast and manage the department budget both for external and internal spend
- Work closely with Quality and Clinical Compliance to ensure quality and continuous process improvement within clinical trial data management
- Effectively represent Data Management departments at project review meetings, quality review meetings, and other stakeholder meetings
- Lead and provide oversight for the execution of data management for all programs and studies of the company and accountable for all data management and clinical programming activities
- Accountable for delivery of departmental infrastructure projects
- Responsible for managing a highly effective team of Managers and Clinical Data Associates supporting highly complex clinical data management
- Has extensive knowledge and understanding of the business beyond the functional area
- Responsible for instructing the implementation of new or advanced systems, processes and resources to increase productivity
- Guides data management activities for regulatory submissions
- Guides CDM organizational strategy and implements departmental change
Requirements
- Doctorate and 10+ years of data management experience
- OR Master's and 12+ years of data management experience
- OR Bachelor's and 14+ years of data management experience
- OR High School Diploma/GED and 18+ years of data management experience
Nice-to-haves
- 16 years of experience in clinical data management in pharmaceutical industry
- Scientific career background
- Experience in oncology therapeutic area; cellular therapy in oncology experience
- 12 years of managerial experience in data management function and experience in leading mid- to large group of data managers
- Experience in clinical trial database build, case report form design and familiar with CDISC and regulatory requirements
- Excellent oral and written communication skills, project and personnel management skills and organizational skills
Benefits
- Company-sponsored medical, dental, vision, and life insurance plans
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
