Senior Director, Clinical Data Management and Analytics

Location: Remote

Iovance Biotherapeutics aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach by harnessing the human immune system to recognize and attack diverse cancer cells. Our TIL platform has demonstrated promising clinical data across multiple solid tumors.

We are committed to continuous innovation in cell therapy, including gene-edited therapies, offering promising treatment options for patients with cancer.

Overview

The Senior Director, Clinical Data Management and Analytics provides leadership to the Clinical Data Management and Analytics Department and influences the broader Clinical Development organization. This role ensures data integrity, supports regulatory compliance, and enables strategic decision-making through advanced analytics, visualization, and data integration.

The position involves hands-on leadership, development of tools and processes, collaboration with cross-functional teams, and building a high-performing data management team.

Key Responsibilities

• Define and execute the vision, strategy, and goals for clinical data management.
• Lead, manage, and develop data management teams, including training and performance reviews.
• Ensure data integrity, quality, and compliance with regulatory requirements (FDA, ICH, GCP).
• Support global clinical trials and regulatory submissions (FDA, EMA).
• Generate insights through advanced analytics and data visualization.
• Collaborate across departments to support clinical development and decision-making.
• Maintain high-quality standards in analysis, reporting, and compliance.
• Drive innovation through new technologies and improved data processes.
• Develop and maintain complex data systems and tools.
• Provide technical guidance to internal teams and external partners.
• Identify efficiency improvements and support continuous improvement initiatives.
• Adhere to company values, policies, and ethical standards.

Required Qualifications

• Extensive experience in clinical data management, preferably in oncology.
• Strong leadership experience in biotech or pharmaceutical industries.
• Proficiency in EDC systems (e.g., Medidata Rave) and CDISC standards.
• Deep understanding of clinical trial processes.
• Excellent communication and interpersonal skills.
• Strong problem-solving and decision-making abilities.
• Bachelor’s, Master’s, or equivalent qualification in a relevant field.
• 13+ years of experience in clinical data management.
• Ability to explain complex technical concepts to non-technical audiences.
• Ability to thrive in a fast-paced, dynamic environment.
• Strong organizational and budget management skills.

Preferred Qualifications

• Experience with AI applications in data management.

Physical Requirements

• Ability to sit or stand for extended periods.
• Ability to lift or move light objects when necessary.
• Visual ability to analyze data and work on screens.
• Repetitive hand and wrist movements.
• Effective verbal communication skills.

Work Environment

This role operates in a professional or remote office environment using standard office equipment.

Salary

$270,000 – $315,000 USD annually

Equal Opportunity

Iovance is committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration without regard to race, religion, gender, age, disability, or any protected characteristic.

For accommodations, contact: careers@iovance.com