[Hiring] Senior Director, Clinical Data Management and Analytics @Iovance Biotherapeutics

Role Description

Senior Director, Clinical Data Management and Analytics, provides leadership to the Clinical Data Management and Analytics Department and provides influence across the Clinical Development organization. As a leader of the Clinical Data Management and Analytics organization, and part of a cross-functional team of drug development scientists focused on providing hands-on skills, expertise, and tools to facilitate strategic development, operational execution, and regulatory compliance to ensure data integrity for clinical trials, in addition to integration, visualization, and exploratory analysis of complex and diverse data in support of clinical development activities and decisions.

• 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.
• Build successful partnerships and seamless interfaces within the department and the broader research and development organization.
• Communicate proactively and effectively across several teams with diverse subject matter expertise.
• Ensure quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs, and work practices.
• Drive the development and implementation of innovative strategies and technologies.
• Independently develop, troubleshoot, and maintain complex programs and utilities in accordance with predefined specifications.
• Provide technical guidance to external partners concerning project and data standards, and analysis practices.
• Identify opportunities for increased efficiency and consistency within the organization.
• Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Qualifications

• 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.
• 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.

Requirements

• Experience with AI applications in the data management space is highly desirable.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
• Ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment

• This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.