Iovance Biotherapeutics, Inc.

Senior Director, Clinical Data Management and Analytics

Iovance Biotherapeutics, Inc.

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical data managementEDC systemsCDISC standardsdata integritydata qualityregulatory compliancedata visualizationprocess improvementprogram developmenttroubleshooting
Soft Skills
leadershipteam developmentcommunicationinterpersonal skillsproblem-solvingdecision-makingcollaborationmotivationadaptabilitypositive attitude
Certifications
MS degreeBS/BA degree