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COMPANY:
At BioCryst , we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at or follow us on LinkedIn and Instagram .
JOB SUMMARY:
BioCryst is a fast-growing pharmaceutical company seeking an experienced Associate Director, IT Business - Partner Pharmaceutical Development to build and mature strategic partnerships across Development. The role supports Program & Portfolio Management, Clinical Development / Operations, Biometrics, Pharmacology / Non-Clinical, Regulatory, Safety, and Medical Affairs. The IT Business Partner will understand functional strategies and operating needs, translate them into technology roadmaps and prioritized initiatives, and enable compliant, scalable process and system improvements across the development lifecycle. This role serves as a strategic technology advisor and delivery leader, with responsibility for business analysis, program and project leadership, solution design, data and integration strategy, vendor management, adoption, and ongoing application support. The role requires working knowledge of key Development platforms and capabilities, including Veeva RIM, Veeva CTMS, ReadCube, clinical data visualization and analytics solutions, and the Oracle Argus safety system. Please note: this role can be remote working east coast with a strong preference for the Boston, MA area.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Serve as the primary IT Business Partner and trusted technology advisor for Program & Portfolio Management, Clinical Development / Operations, Biometrics, Pharmacology / Non-Clinical, Regulatory, Safety, and Medical Affairs.
Build strong partnerships with functional leaders and subject matter experts to understand strategies, business 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 the selection, implementation, enhancement, integration, and support of Development applications and data capabilities.
Partner with business and IT stakeholders to optimize platforms including Veeva RIM, Veeva CTMS, ReadCube, clinical data visualization and analytics solutions, Oracle Argus, and related Development systems.
Develop a working understanding of Development processes and data flows, including clinical study operations, regulatory information and submissions, safety and pharmacovigilance, biometrics, non-clinical activities, processes, and medical information or evidence-generation needs.
Collaborate with Enterprise Architecture, Data and Analytics, Information Security, Infrastructure, Integration, and IT Compliance teams to design scalable, secure, reliable, and supportable solutions.
Ensure GxP and other regulated applications are implemented and maintained in accordance with applicable 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 other Development partners.
Partner with Clinical, Biometrics, and Data and Analytics teams to 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 practical opportunities that support Development priorities and compliance expectations.
This is an individual contributor role with no direct reports. The role leads and manages MSPs, contractors, vendors, and consultants, as needed, for project implementation, project delivery, and ongoing system support.
Contribute to IT standards, policies, procedures, governance practices, and continuous-improvement efforts.
Perform other duties as assigned.
EXPERIENCE & QUALIFICATIONS:
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 of the following areas: Program & Portfolio Management, Clinical Development / Operations, Biometrics, Pharmacology / Non-Clinical, Regulatory, Safety, and Medical Affairs.
Experience in 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, with the ability to communicate effectively with business leaders, technical teams, end users, and vendors.
Ability to manage multiple priorities, navigate ambiguity, influence without direct authority, and work effectively both as a leader and as a contributing team member.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing 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. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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