Director, IT Business Partner - R&D & GxP Systems

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About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients - realizing a world where people with immune-mediated diseases can live life fully. Job Summary: The Director, IT Business Partner - R&D & GxP Systems is responsible for shaping and executing the technology strategy that enables Beeline's clinical development programs. This role serves as the primary IT leader for all R&D-facing functions - Clinical Operations, Regulatory Affairs, Pharmacovigilance, Quality Assurance, CMC/Technical Operations, and Data Science - translating business needs into compliant, scalable technology solutions across the company's regulated systems portfolio. This is an ownership role. You will own the R&D systems roadmap, set the direction for GxP computerized system assurance, govern the company's Veeva Vault platform and GxP document management systems, and serve as the strategic technology partner to functional leaders across R&D. You will design the validation strategy, decide what level of assurance each system requires, and defend those decisions to regulators. You will represent IT in all regulatory audits and inspections, serving as the company's subject matter expert on GxP computerized systems. You define the work, set the priorities, and own the outcomes. This is a key leadership position within a small, high-impact IT team at a clinical-stage biopharma advancing through clinical development. You will build the GxP systems program from the ground up as the company grows. The role reports to the VP of IT and works in close partnership with the Head of Quality under the established principle: Quality owns validation governance, IT contributes technical leadership. Work Arrangement & Location: Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week - currently designated as Tuesday and Wednesday . Additional on-site days may be required based on business needs, team priorities, or leadership direction. Essential Duties and Responsibilities: R&D Technology Strategy & Ownership. Own the R&D technology roadmap across Clinical Operations, Regulatory Affairs, Pharmacovigilance, Quality Assurance, CMC/Technical Operations, and Data Science. Evaluate, recommend, and implement technology solutions that advance clinical programs while meeting GxP, FDA, and EMA regulatory requirements. You set the systems strategy for R&D - not just execute on someone else's plan. GxP Platform Governance. Serve as System Owner (per GAMP 5) for company-owned GxP platforms, including Veeva Vault (eTMF, RIM, QMS, QualityDocs) and Egnyte (GxP EDMS). Own the technical architecture, security configuration, environment management, integration design, user provisioning, disaster recovery, and vendor technical relationships for these platforms. You are accountable for these systems - their reliability, compliance, and evolution. Computer System Validation & Assurance. Lead the company's IT contribution to computer system validation and assurance under GAMP 5 Second Edition and the FDA's Computer Software Assurance (CSA) guidance. Author risk-based validation strategies, execute infrastructure qualification and technical IQ/OQ, conduct 21 CFR Part 11 and EU Annex 11 compliance assessments, and contribute to periodic reviews. Work within the Quality-owned validation framework while bringing the technical judgment that determines what to test, how deeply, and why. CRO & Partner Technology Oversight. Manage technology relationships with CROs, CDMOs, and external partners. Evaluate CRO technology capabilities during vendor selection, negotiate data transfer agreements, ensure CRO-managed systems (EDC, RTSM, eCOA, safety database) interface correctly with company-owned platforms, and provide IT input to quality agreements. Own the sponsor side of all cross-system data integrations, including clinical data reconciliation and regulatory submission data flows. Vendor Security & Qualification. Provide IT security assessments for GxP vendor qualification, feeding into Quality's supplier qualification record. Evaluate vendor SOC reports, ISO certifications, Part 11 compliance, and data handling practices. Contribute to the company's third-party risk management process for R&D technology vendors in coordination with the

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