Senior Director, Clinical Data Management and Analytics

Role Overview

• Define and implement the overall vision, strategy, and goals for the clinical data management department.
• Lead, manage, and develop data management teams, handling resource planning, staff training, and performance reviews.
• 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).
• Generate novel insights from data and present them via rich and intuitive visualizations.
• Builds successful partnerships and seamless interfaces within the department and the broader research and development organization. Communicates proactively and effectively across several teams with diverse subject matter expertise.
• Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs, and work practices.
• Drives the development and implementation of innovative strategies and technologies.
• Independently develops, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and build upon existing Iovance standards.
• Provides technical guidance to external partners concerning project and data standards, and analysis practices to ensure efficient and integrated project strategies.
• Identifies opportunities for increased efficiency and consistency within the organization and provides SME support to continuous improvement initiatives.
• Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Performs miscellaneous duties as assigned.

Requirements

• Extensive experience in clinical data management 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.
• Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency.
• Demonstrated ability to lead, motivate, and develop teams.
• 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.
• MS, BS/BA degree, or other suitable qualification with relevance to the field.
• 13 or more years’ direct experience in clinical data management in the biotechnology OR Pharmaceutical industry.
• Excellent verbal and written communication skills and strong interpersonal skills are required.
• Demonstrated ability to develop and lead a team of individuals with diverse experience and expertise.
• Ability to explain technically complex information for a non-technical audience.
• Strong positive attitude, thrives in a dynamic, fast paced environment with many simultaneous projects.
• Demonstrates the ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.

Benefits

• Reasonable accommodations may be made upon request to enable individuals to perform essential functions.