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

Beeline Medicines•Boston, MA

1d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related discipline; advanced degree preferred.
10+ years of IT experience in pharmaceutical, biotech, or other GxP-regulated environment with at least 5 years supporting R&D functions (clinical operations, regulatory affairs, pharmacovigilance, quality, or CMC).
Demonstrated experience as System Owner or technical lead for GxP-regulated platforms such as Veeva Vault, Medidata, IQVIA, or equivalent clinical/regulatory systems.
Hands-on experience with computer system validation (CSV) and/or Computer Software Assurance (CSA), including risk-based validation strategy, GAMP 5 system categorization, infrastructure qualification, and 21 CFR Part 11 / EU Annex 11 compliance.
Working knowledge of ICH E6(R2)/E6(R3) GCP requirements, CDISC standards (SDTM/ADaM), and regulatory submission data flows as they affect IT.
Experience at a clinical-stage biotech with an outsource-heavy operating model where CROs manage EDC, RTSM, safety databases, and other trial systems.
Experience with the Veeva Vault platform across multiple applications (eTMF, RIM, QMS, QualityDocs, CTMS).
Strategic technology thinking — evaluates systems in the context of clinical program timelines, regulatory milestones, and company growth trajectory, not just technical requirements.
Cross-functional partnership — earns credibility with clinical, regulatory, quality, and scientific leaders by understanding their work deeply enough to anticipate technology needs before they become requests.
Strong written and verbal communication skills with the ability to serve as a credible partner to clinical, regulatory, quality, and scientific stakeholders.
Direct experience representing IT or participating in FDA, EMA, or other regulatory inspections and audits involving computerized systems.
Vendor and integration management — manages complex technology relationships with platform vendors, CROs, and implementation partners across multiple concurrent workstreams.

Responsibilities

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.
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.
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.
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.
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.
Design and manage cross-functional data flows, reporting, and analytics across R&D systems.
Own the technology layer for clinical and regulatory dashboards, ensure data integrity across integrated platforms, and support CDISC-compliant data pipelines from EDC through Pinnacle 21 to regulatory submission.
Build and maintain trusted partnerships with R&D functional leaders — VP Quality, heads of Clinical Operations, Regulatory, Pharmacovigilance, CMC, and Data Science.
Attend their governance meetings.
Understand their clinical milestones and regulatory timelines.
Translate their challenges into technology initiatives and advocate for the investments that matter most.
Perform other duties and responsibilities as assigned.