Associate Director, R&D, Commercial IT

Iovance Biotherapeutics, Inc.

. Partner with R&D and Commercial stakeholders to select, implement, and support systems for clinical development, regulatory, safety, and commercial operations .

Posted 11/3/2026full-timeRemote • United StatesSenior💰 $175,000 - $200,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in administering and configuring R&D and Commercial applications, including Veeva Vault and Argus Drug Safety, while ensuring compliance with FDA regulations and managing vendor relationships. Proven ability to lead system implementations and migrations, translating business needs into effective IT solutions.

Highest-signal resume keywords

Veeva Vault AdministrationRegulatory Information Management (RIM)GxP ComplianceClinical Operations ManagementProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Data ManagementRegulatory AffairsDrug SafetyData MigrationSystem ValidationConfiguration ManagementUser Access ManagementSOP AuthoringChange Control ProceduresVendor Management

Soft Skills

Strong CommunicationStakeholder ManagementProblem-SolvingAnalytical ThinkingProject Management Skills

Tools & Technologies

Generis CARAVeeva eTMFArgus Drug SafetyDocuBridgeMagnifi LMSVeeva CRMVeeva NetworkVeeva PromoMats

Certifications & Qualifications

PMPVeeva Vault Administrator

Industry Keywords

BiotechPharmaceuticalLife SciencesClinical DevelopmentFDA 21 CFR Part 11GxPPharmacovigilanceCell TherapyGene TherapyOncology

Tech Stack

Tools & technologies

PMPVault

About the role

Key responsibilities & impact

Partner with R&D and Commercial stakeholders to select, implement, and support systems for clinical development, regulatory, safety, and commercial operations
Lead the transition from Veeva Vault RIM to Generis CARA, including scope, timeline, data migration, validation, cutover, vendor and stakeholder coordination, and leadership status reporting
Translate business needs into system requirements and deliver IT solutions with Clinical Data Management, Clinical Operations, Regulatory Affairs, Drug Safety, and Biometrics
Administer and own R&D applications including Generis CARA/Veeva RIM, Veeva eTMF, Argus Drug Safety, DocuBridge, and Magnifi LMS (Clinical)
Administer Commercial applications including Veeva CRM, Veeva Network, Veeva PromoMats, and Magnifi LMS (ATC Ops)
Manage user access, security roles, configuration, releases, upgrades, and vendor-driven changes under change-control procedures
Ensure validation and compliance with FDA 21 CFR Part 11, GxP, and applicable data-integrity requirements; support audits and inspections
Author, review, and maintain validation deliverables, SOPs, work instructions, and configuration specifications
Direct vendor resources, assign priorities, review deliverables, and monitor statement-of-work performance
Manage vendor and managed-service relationships, including SLAs and statements of work
Provide escalation support, drive root-cause analysis, and implement corrective actions
Contribute to budgets and roadmaps for the R&D and Commercial application portfolio
Adhere to Iovance Biotherapeutics’ values, policies, procedures, and business ethics
Perform miscellaneous duties as assigned

Requirements

What you’ll need

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, including 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
Preferred: Direct experience with regulatory information management (RIM) implementations or migrations, ideally Generis CARA
Preferred: Experience with Veeva CRM, Network, or PromoMats, or with an LMS such as Magnifi
Preferred: Experience in cell or gene therapy, oncology, or other advanced-therapy environments
Preferred: PMP, Veeva Vault administrator, or similar certifications
Preferred: Familiarity with regulatory submission publishing and eTMF inspection readiness
Ability to remain in a stationary position for extended periods
Ability to move about within an office or remote workspace and exert up to 10 pounds of force occasionally
Visual acuity sufficient for preparing and analyzing data, viewing computer screens, and extensive reading
Repetitive motion involving wrists, hands, and/or fingers
Ability to communicate effectively to exchange information
Ability to engage in analytical, conceptual, and problem-solving activities in a dynamic business environment
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion
Ability to handle work-related stress and multiple priorities simultaneously with a sense of urgency
Ability to meet deadlines