R&D & Commercial IT Lead — CARA Transition

Iovance Biotherapeutics, Inc.; Philadelphia (Philadelphia County); À distance; USD 140 000 - 190 000; Plein temps

Résumé du poste

Iovance Biotherapeutics, Inc. is seeking an Associate Director, R&D and Commercial IT to partner with R&D and Commercial stakeholders and lead the systems that run clinical development, regulatory, safety, and commercial operations.

The role focuses on migrating regulatory information management from Veeva Vault RIM to Generis CARA and owns a portfolio of validated R&D and Commercial applications. As an individual contributor, you will manage system administration, validate compliance with FDA

Qualifications

• Bachelor's degree in Information Systems, Computer Science, Life Sciences, or related field.
• 10+ years IT experience in biotech, pharma, or life sciences including 5+ years supporting R&D or clinical/regulatory systems.
• Hands-on experience administering Veeva Vault (RIM/eTMF) or similar regulated R&D apps.
• Working knowledge of GxP, 21 CFR Part 11, and computer system validation.

Responsabilités

• Lead the Veeva Vault RIM to Generis CARA transition (scope, timeline, data migration, validation, cutover).
• Partner with Clinical Data Management, Clinical Operations, Regulatory Affairs, Drug Safety, and Biometrics to translate needs into system requirements.
• Serve as system administrator and owner for R&D and Commercial apps (CARA/Veeva RIM, eTMF, Argus, DocuBridge, Magnifi LMS).
• Manage user access, security roles, configurations, releases, upgrades, and change control.
• Ensure validation and compliance with FDA 21 CFR Part 11, GxP, and data integrity; support audits/inspections.

Connaissances

IT leadership

RIM / QA systems

Regulatory knowledge

Veeva Vault

PM skills

Formation

Bachelor degree in Information Systems / Life Sciences or related field

Outils

Veeva Vault

Generis CARA

Argus Drug Safety

DocuBridge

Magnifi LMS

Veeva CRM

Description du poste

Iovance Biotherapeutics, Inc. is seeking an Associate Director, R&D and Commercial IT to partner with R&D and Commercial stakeholders and lead the systems that run clinical development, regulatory, safety, and commercial operations.

The role focuses on migrating regulatory information management from Veeva Vault RIM to Generis CARA and owns a portfolio of validated R&D and Commercial applications. As an individual contributor, you will manage system administration, validate compliance with FDA