Associate Director, R&D, Commercial IT

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with R&D and Commercial partners to choose, implement, and maintain systems for clinical development, regulatory, safety, and commercial operations.

• Lead the migration from Veeva Vault RIM to Generis CARA, covering scope, timeline, data migration, validation, cutover, vendor coordination, and stakeholder leadership reporting.

• Convert business needs into system requirements and provide IT solutions to Clinical Data Management, Clinical Operations, Regulatory Affairs, Drug Safety, and Biometrics.

• Manage and oversee R&D applications such as Generis CARA/Veeva RIM, Veeva eTMF, Argus Drug Safety, DocuBridge, and Magnifi LMS (Clinical).

• Oversee Commercial applications including Veeva CRM, Veeva Network, Veeva PromoMats, and Magnifi LMS (ATC Ops).

• Control user access, security roles, configuration, releases, upgrades, and vendor-driven modifications following change-control protocols.

• Ensure validation and compliance with FDA 21 CFR Part 11, GxP, and relevant data-integrity standards; assist with audits and inspections.

• Create, review, and maintain validation documentation, SOPs, work instructions, and configuration specifications.

• Direct vendor resources, prioritize tasks, review outputs, and track statement-of-work performance.

• Manage vendor relationships and managed-services, including SLAs and statements of work.

• Provide escalation support, facilitate root-cause analysis, and implement corrective measures.

• Contribute to budgeting and planning for the R&D and Commercial application portfolio.

• Uphold Iovance Biotherapeutics’ values, policies, procedures, and ethical standards.

• Perform various other responsibilities as assigned.

⛳️ Requirements

• Bachelor’s degree in Information Systems, Computer Science, Life Sciences, or a related field, or equivalent experience.

• Over 10 years of IT experience in biotech, pharmaceutical, or life sciences, with at least 5 years supporting R&D or clinical/regulatory systems.

• Hands-on experience in managing and configuring one or more of the following: Veeva Vault (RIM, eTMF, etc.), Argus Safety, or similar regulated R&D applications.

• Familiarity with GxP, 21 CFR Part 11, and computer system validation.

• Experience in leading system implementations or migrations throughout the entire lifecycle.

• Experience in vendor and consultant management.

• Strong knowledge of at least two R&D functions: Clinical Operations, Clinical Data Management, Regulatory Affairs, Drug Safety/Pharmacovigilance, or Biometrics.

• Excellent communication, stakeholder management, and project management abilities.

• Willingness to learn and manage Commercial systems.

• Preferred: Direct experience with regulatory information management (RIM) implementations or migrations, ideally with Generis CARA.

• Preferred: Experience with Veeva CRM, Network, or PromoMats, or with an LMS such as Magnifi.

• Preferred: Background in cell or gene therapy, oncology, or other advanced-therapy settings.

• Preferred: PMP, Veeva Vault administrator, or similar certifications.

• Preferred: Knowledge of regulatory submission publishing and eTMF inspection readiness.

• Ability to remain in a stationary position for prolonged periods.

• Capability to navigate within an office or remote workspace and occasionally exert up to 10 pounds of force.

• Visual acuity sufficient for data preparation and analysis, computer screen viewing, and extensive reading.

• Repetitive motion involving wrists, hands, and/or fingers.

• Proficient communication skills for effective information exchange.

• Ability to engage in analytical, conceptual, and problem-solving tasks in a dynamic business environment.

• Clear conceptual thinking ability; strong judgment, troubleshooting, problem-solving, analytical skills, and discretion.

• Capacity to manage work-related stress and multiple priorities simultaneously with urgency.

• Ability to meet deadlines.

🏝️ Benefits

• Comprehensive health benefits package.

• Competitive salary and performance bonuses.

• Opportunities for professional development and training.

• Flexible work arrangements.

• Supportive and inclusive company culture.