Associate Director, R&D and Commercial IT
Iovancebiotherapeutics · Remote
About this role
**Associate Director, R&D and Commercial IT** **About the Company** Iovance Biotherapeutics is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved treatment for previously treated advanced melanoma. **Role Overview** Partner with R&D and Commercial stakeholders to select, implement, and support systems running clinical development, regulatory, safety, and commercial operations. Lead the transition from Veeva Vault RIM to Generis CARA, and serve as system owner/administrator for R&D and Commercial applications. **Key Responsibilities** • Lead Veeva Vault RIM to Generis CARA transition (scope, timeline, data migration, validation, cutover) • Partner with Clinical Data Management, Regulatory Affairs, Drug Safety, and Biometrics teams • Administer R&D applications: Generis CARA, Veeva eTMF, Argus Drug Safety, DocuBridge, Magnifi LMS • Administer Commercial applications: Veeva CRM, Veeva Network, Veeva PromoMats, Magnifi LMS • Manage user access, security roles, configuration, releases, and upgrades • Ensure FDA 21 CFR Part 11 and GxP compliance • Author and maintain system documentation and validation deliverables • Direct vendor resources and manage vendor relationships • Provide escalation support and drive root-cause analysis **Required Qualifications** • Bachelor's degree in Information Systems, Computer Science, Life Sciences, or related field • 10+ years IT experience in biotech/pharma/life sciences • 5+ years supporting R&D or clinical/regulatory systems • Hands-on experience with Veeva Vault, Argus Safety, or comparable regulated applications • Working knowledge of GxP and 21 CFR Part 11 • Experience leading system implementations/migrations • Vendor management experience • Understanding of Clinical Operations, Data Management, Regulatory Affairs, Drug Safety, or Biometrics • Strong communication and project management skills **Preferred Qualifications** • RIM implementation/migration experience (ideally Generis CARA) • Experience with Veeva CRM, Network, PromoMats, or Magnifi LMS • Cell/gene therapy or oncology background • PMP or Veeva Vault certifications • eTMF inspection readiness knowledge **Compensation** $175,000 – $200,000 USD **Work Environment** Remote-eligible professional office environment. Standard office equipment and keyboards required. **Equal Opportunity** Iovance is an equal-opportunity employer committed to diversity and inclusion.
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