Associate Director, IT Business Partner – Pharmaceutical Development

🕒 5 dias atrás

🌲 North Carolina, Massachusetts – Remoto

🌲 North Carolina – Remote 🍂 Massachusetts – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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BioCryst Pharmaceuticals, Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $450.000.000 Post-IPO Debt - BioCryst Pharmaceuticals em 2023-04

Healthcare • Consulting • Logistics

A BioCryst Pharmaceuticals, Inc. é uma empresa global de biotecnologia focada na descoberta, desenvolvimento e comercialização de novos tratamentos orais com pequenas moléculas e proteínas para doenças raras, notadamente o angioedema hereditário (AEH). Fundada em 1986, a BioCryst utiliza design de medicamentos guiado por estrutura, química medicinal e tecnologias avançadas para desenvolver medicamentos de primeira classe ou superiores, e trabalha em estreita colaboração com pacientes, grupos de apoio e parceiros globais para levar os tratamentos ao mercado.

Descrição

• Serve as the primary IT Business Partner and trusted technology advisor for Development and R&D functions • Build partnerships with functional leaders and subject matter experts to understand strategies, capabilities, pain points, risks, and priorities • Translate business priorities into multi-year technology roadmaps, business cases, demand plans, and sequenced delivery portfolios • Lead demand intake, discovery, requirements definition, solution evaluation, prioritization, implementation, adoption, and value realization for Development technology initiatives • Provide subject matter expertise for selecting, implementing, enhancing, integrating, and supporting Development applications and data capabilities • Partner with business and IT stakeholders to optimize Veeva RIM, Veeva CTMS, ReadCube, clinical data visualization and analytics solutions, Oracle Argus, and related systems • Develop understanding of Development processes and data flows across clinical study operations, regulatory submissions, safety and pharmacovigilance, biometrics, non-clinical activities, and medical information or evidence generation • Collaborate with Enterprise Architecture, Data and Analytics, Information Security, Infrastructure, Integration, and IT Compliance teams to design scalable, secure, reliable, supportable solutions • Ensure GxP and other regulated applications meet validation, data integrity, privacy, security, change control, and records-management requirements • Oversee system lifecycle activities including application ownership, release management, vendor upgrades, incident and problem management, access governance, business continuity, disaster recovery, and application retirement • Promote consistent master data, system interoperability, and integrated data flows across internal platforms, CROs, service providers, and Development partners • Improve access to trusted study information and strengthen clinical data visualization, reporting, and decision support • Lead cross-functional programs and projects, managing scope, schedule, budget, resources, risks, dependencies, decisions, communications, and executive-level status reporting • Manage strategic technology vendors and managed service providers, including performance, service levels, delivery quality, contracts, and issue escalation • Drive user adoption through stakeholder engagement, communications, training, process documentation, and change-management activities • Monitor emerging technologies including automation, analytics, and responsible AI, and recommend opportunities supporting Development priorities and compliance expectations • Lead and manage MSPs, contractors, vendors, and consultants for project implementation, delivery, and ongoing system support • Contribute to IT standards, policies, procedures, governance practices, and continuous-improvement efforts • Perform other duties as assigned

🎯 Requisitos

• Bachelor’s degree in information technology, computer science, business, life sciences, or a related discipline, or an equivalent combination of education and experience • At least 8–10 years of progressive experience delivering and managing information technologies and services in a corporate environment, preferably in the pharmaceutical, biotechnology, or broader life sciences industry • Demonstrated experience as an IT Business Partner, product owner, application leader, program manager, or similar role supporting Development or R&D business functions • Strong knowledge of business processes and information needs across several Development and R&D areas • Experience managing, enhancing, integrating, or supporting Veeva RIM and Veeva CTMS or comparable regulatory and clinical platforms • Knowledge of Oracle Argus or a comparable pharmacovigilance and safety system • Knowledge of SAS (LSAF) and A2Ai • Knowledge of ReadCube or comparable scientific literature and reference-management solutions • Knowledge of clinical data sources, standards, reporting, and visualization approaches used to support study oversight and Development decision-making • Experience with regulated GxP computerized systems, including validation, data integrity, audit trails, electronic records and signatures, security, change control, and inspection readiness • Experience leading application implementations and lifecycle management in cloud-based, client-server, and web-based environments • Experience with system integrations, data flows, vendor-hosted platforms, and external partners such as CROs and managed service providers • Strong business analysis, process-improvement, solution-evaluation, program and project management, resource planning, and vendor-management skills • Demonstrated ability to develop technology roadmaps, investment proposals, implementation plans, operating models, and measurable outcomes • Experience leading contractors and external partners in a matrixed and cross-functional environment • Strong interpersonal, written, verbal, facilitation, and presentation skills • Ability to manage multiple priorities, navigate ambiguity, influence without direct authority, and work effectively both as a leader and as a contributing team member

🏖️ Benefícios

• Equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities