Associate Director, IT Business Partner – Pharmaceutical Development

🕒 vor 1 Monat

🌲 North Carolina, Massachusetts – Remote

🌲 North Carolina – Remote 🍂 Massachusetts – Remote

⏰ Vollzeit

🔴 Experte

👔 Direktor

👻 Geisterscore 10%

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• Seit 41 Tagen offen.
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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAlle Stellen

501 - 1000 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

💰 €450.000.000 Post-IPO Debt - BioCryst Pharmaceuticals im 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. ist ein global tätiges Biotechnologieunternehmen, das sich auf die Entdeckung, Entwicklung und Vermarktung neuartiger oraler kleiner Moleküle und Proteintherapeutika für seltene Krankheiten, insbesondere hereditäres Angioödem (HAE), konzentriert. Seit seiner Gründung im Jahr 1986 nutzt BioCryst strukturgeleitetes Wirkstoffdesign, medizinische Chemie und fortschrittliche Technologien, um erstklassige oder best-in-class Medikamente zu entwickeln, und arbeitet eng mit Patienten, Interessengruppen und globalen Partnern zusammen, um Behandlungen auf den Markt zu bringen.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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

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