About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics, Inc. 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, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com.

Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.

Overview

The Associate Director, R&D and Commercial IT partners with R&D and Commercial stakeholders to select, implement, and support the systems that run Iovance's clinical development, regulatory, safety, and commercial operations. This is an individual contributor role in collaboration with managed services partners. This role is responsible for leading the transition of regulatory information management from Veeva Vault RIM to Generis CARA. Additionally, it serves as system owner and administrator for a portfolio of validated R&D applications and a set of Commercial applications. The role carries a primary R&D focus, and the ideal candidate has R&D domain expertise and is open to learning and administering the Commercial systems.

Essential Functions and Responsibilities

Lead the Veeva Vault RIM to Generis CARA transition, including scope, timeline, data migration, validation, cutover, vendor and stakeholder coordination, and status reporting to leadership.
Partner with Clinical Data Management, Clinical Operations, Regulatory Affairs, Drug Safety, and Biometrics to understand business needs, translate them into system requirements, and deliver IT solutions.
Serve as system administrator and business/IT owner for R&D applications, including Generis CARA / Veeva RIM, Veeva eTMF, Argus Drug Safety, DocuBridge, and Magnifi LMS (Clinical).
Serve as system administrator for Commercial applications, including Veeva CRM (event management and ENGAGE), Veeva Network, Veeva PromoMats, and Magnifi LMS (ATC Ops), and partner with Commercial stakeholders on enhancements and new requirements.
Manage user access, security roles, configuration, releases, upgrades, and vendor-driven change in line with change control procedures.
Ensure systems are validated and maintained in compliance with FDA 21 CFR Part 11, GxP, and applicable data integrity requirements, and support audits and inspections as needed.
Author, review, and maintain system documentation, such as validation deliverables, SOPs, work instructions, and configuration specifications.
Direct the work of a vendor resource that supplements the internal team, including assigning priorities, reviewing deliverables, and monitoring performance against the statement of work.
Manage vendor and managed-service relationships, including SLAs and statements of work.
Provide escalation support for incidents and problems, and drive root-cause analysis and corrective actions.
Contribute to budgets and roadmaps for the R&D and Commercial application portfolio.
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.