Remote Associate Director, R&D & Commercial IT (Veeva/CARA)

Iovance Biotherapeutics, Inc.; United States; Remote; USD 175,000 - 200,000; Full time

Job summary

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

This is a remote, individual-contributor role working with managed services partners. You will own the transition from Veeva Vault RIM to Generis CARA, administer both R&D and Commercial applications, manage vendor relationships, ensure 21 CFR Part 11 compliance, and collaborate with multiple

Qualifications

• Bachelor's degree in IT, life sciences, or related field or equivalent experience.
• 10+ years IT experience in biotech, pharma, or life sciences, with 5+ years supporting R&D or clinical/regulatory systems.
• Hands-on experience administering Veeva Vault (RIM/eTMF) or Argus Safety.
• Working knowledge of GxP and 21 CFR Part 11; experience with computer system validation.
• Experience leading system implementations or migrations.

Responsibilities

• Lead the Veeva Vault RIM to Generis CARA transition, including scope, data migration, validation, cutover, vendor and stakeholder coordination.
• Partner with Clinical Data Management, Clinical Operations, Regulatory Affairs, Drug Safety and Biometrics to translate needs into IT solutions.
• Serve as system administrator and owner for R&D apps (Generis CARA/Veeva RIM, Veeva eTMF, Argus Safety, DocuBridge, Magnifi LMS).
• Serve as system administrator for Commercial applications (Veeva CRM, Network, PromoMats, Magnifi LMS) and partner on enhancements.
• Manage user access, security roles, configuration, releases, upgrades, and change control procedures.
• Ensure systems validated and compliant with FDA 21 CFR Part 11, GxP; support audits and inspections.

Skills

Veeva Vault

Generis CARA

Veeva CRM

RIM eTMF

GxP

21 CFR Part 11

Vendor management

Project management

Stakeholder mgmt

Communication

IT leadership

Education

Bachelor's degree in Information Systems, Computer Science, Life Sciences, or related field

Tools

Veeva Vault

Generis CARA

Veeva CRM

Argus Safety

DocuBridge

Magnifi LMS

Job description

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

This is a remote, individual-contributor role working with managed services partners. You will own the transition from Veeva Vault RIM to Generis CARA, administer both R&D and Commercial applications, manage vendor relationships, ensure 21 CFR Part 11 compliance, and collaborate with multiple