Associate Director, R&D and Commercial IT
About The Position
The Associate Director, R&D and Commercial IT partners with R&D and Commercial stakeholders to select, implement, and support systems used for clinical development, regulatory, safety, and commercial operations. This is an individual contributor role that works in collaboration with managed services partners, with a primary focus on R&D and an expectation that the successful candidate will learn and administer Commercial systems. The role leads the transition of regulatory information management from Veeva Vault RIM to Generis CARA and serves as system owner and administrator for a portfolio of validated R&D applications and a set of Commercial applications. Responsibilities also include vendor and stakeholder coordination, systems compliance and validation, application support, documentation, and contributions to portfolio budgets and roadmaps.
Requirements
- 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.
Nice To Haves
- Direct experience with regulatory information management (RIM) implementations or migrations, ideally Generis CARA.
- Experience with Veeva CRM, Network, or PromoMats, or with an LMS such as Magnifi.
- Experience in cell or gene therapy, oncology, or other advanced-therapy environments.
- PMP, Veeva Vault administrator, or similar certifications.
- Familiarity with regulatory submission publishing and eTMF inspection readiness.
Responsibilities
- Lead the Veeva Vault RIM to Generis CARA transition, including scope, timeline, data migration, validation, cutover, vendor and stakeholder coordination, and leadership status reporting.
- 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.
- Administer and serve as business/IT owner for R&D applications, including Generis CARA / Veeva RIM, Veeva eTMF, Argus Drug Safety, DocuBridge, and Magnifi LMS (Clinical).
- Administer 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 requirements.
- Manage user access, security roles, configuration, releases, upgrades, and vendor-driven changes in accordance with change control procedures.
- Ensure systems are validated and maintained in compliance with FDA 21 CFR Part 11, GxP, and applicable data integrity requirements; support audits and inspections as needed.
- Author, review, and maintain system documentation, including validation deliverables, SOPs, work instructions, and configuration specifications.
- Direct the work of a vendor resource by 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.
- Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Director
