Associate Director, R&D and Commercial IT
Iovance Biotherapeutics
WorldwideFully remoteFull TimeMid Level, SeniorInformation Technology
USD 175,000–200,000 a yearPosted 3 hours ago3h agoApply link checked 2 hours ago
Why we think you can apply
- Hiring model
- Open worldwide · the employer states no country restriction
- Work from
- Anywhere, the UAE included
Posted 3 hours ago · apply link checked 2 hours ago
About the role
Responsibilities
- Lead the Veeva Vault RIM to Generis CARA transition, including validation and cutover
- Partner with Clinical, Regulatory, Safety and Biometrics stakeholders to translate needs into IT solutions
- Serve as system administrator and business/IT owner for R&D applications
- Serve as system administrator for Commercial applications such as Veeva CRM and PromoMats
- Manage user access, configuration, releases and vendor-driven change under change control
- Ensure systems are validated and compliant with FDA 21 CFR Part 11 and GxP
- Author and maintain validation deliverables, SOPs and configuration specifications
- Direct a vendor resource and manage managed-service relationships and SLAs
- Provide escalation support and drive root-cause analysis and corrective actions
- Contribute to budgets and roadmaps for the R&D and Commercial application portfolio
Requirements
- Bachelor's degree in Information Systems, Computer Science, Life Sciences or related field, or equivalent experience
- 10+ years IT experience in biotech, pharma or life sciences, including 5+ years supporting R&D or regulatory systems
- Hands-on administration of Veeva Vault, 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 communication, stakeholder management and project management skills
- Willingness to learn and administer Commercial systems
Preferred Qualifications
- Experience with regulatory information management implementations, ideally Generis CARA
- Experience with Veeva CRM, Network or PromoMats, or an LMS such as Magnifi
- Experience in cell or gene therapy, oncology or advanced-therapy environments
- PMP or Veeva Vault administrator certification
About the Company
- Global leader in tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with fully owned U.S.-based manufacturing.
What we look for
- Bachelor's degree in Information Systems, Computer Science, Life Sciences or related field, or equivalent experience
- 10+ years IT experience in biotech, pharma or life sciences, including 5+ years supporting R&D or regulatory systems
- Hands-on administration of Veeva Vault, 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 communication, stakeholder management and project management skills
- Willingness to learn and administer Commercial systems
- Experience with regulatory information management implementations, ideally Generis CARA
- Experience with Veeva CRM, Network or PromoMats, or an LMS such as Magnifi
- Experience in cell or gene therapy, oncology or advanced-therapy environments
- PMP or Veeva Vault administrator certification
Project Managementvendor managementStakeholder ManagementVeeva VaultGxPVeeva CRMArgus SafetyComputer System Validation21 CFR Part 11Generis CARA
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Iovance Biotherapeutics
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