Associate Director, R&D and Commercial IT

The role

The Associate Director, R&D and Commercial IT partners with stakeholders to select, implement, and support systems for clinical development, regulatory, safety, and commercial operations. This individual contributor role leads the transition of regulatory information management from Veeva Vault RIM to Generis CARA and serves as a system owner for R&D and Commercial applications.

What you will do

• Lead the Veeva Vault RIM to Generis CARA transition.
• Partner with R&D and Commercial stakeholders to deliver IT solutions.
• Serve as system administrator and business/IT owner for R&D applications.
• Serve as system administrator for Commercial applications.
• Manage user access, security roles, configuration, releases, and upgrades.
• Ensure systems are validated and maintained in compliance with FDA 21 CFR Part 11 and GxP.
• Author, review, and maintain system documentation.
• Direct the work of a vendor resource.
• Manage vendor and managed-service relationships.
• Provide escalation support for incidents and problems.

Required qualifications

• Bachelor's degree in Information Systems, Computer Science, Life Sciences, or a related field, or equivalent experience.
• 10+ years of IT experience in biotech, pharmaceutical, or life sciences.
• 5+ years supporting R&D or clinical/regulatory systems.
• Hands-on experience administering and configuring one or more of: Veeva Vault (RIM, eTMF, or other), Argus Safety, or comparable regulated R&D applications.
• Working knowledge of GxP, 21 CFR Part 11, and computer system validation.
• Experience leading system implementations or migrations through the full lifecycle.
• Experience managing vendors and consultants.
• Strong understanding of at least two R&D functions: Clinical Operations, Clinical Data Management, Regulatory Affairs, Drug Safety/Pharmacovigilance, or Biometrics.
• Strong communication, stakeholder management, and project management skills.
• Willingness to learn and administer Commercial systems.

Nice to have

• Direct experience with regulatory information management (RIM) implementations or migrations, ideally Generis CARA.
• Experience with Veeva CRM, Network, or PromoMats, or with an LMS such as Magnifi.
• Experience in cell or gene therapy, oncology, or other advanced-therapy environments.
• PMP, Veeva Vault administrator, or similar certifications.
• Familiarity with regulatory submission publishing and eTMF inspection readiness.

About the company

Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. The company operates as an end-to-end cell therapy company with centralized U.S.-based manufacturing.