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

About the role

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.

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 Senior Director, Information Security & Compliance.
• R&D Data Integration & Analytics. 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. Enable R&D leadership to make data-driven decisions through reliable, validated reporting infrastructure.
• Strategic Business Partnership. 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. You are their technology partner, not their vendor.

Qualifications

• Education: Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related discipline; advanced degree preferred.
• Experience: 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).
• Experience: Demonstrated experience as System Owner or technical lead for GxP-regulated platforms such as Veeva Vault, Medidata, IQVIA, or equivalent clinical/regulatory systems.
• Experience: 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.
• Experience: Working knowledge of ICH E6(R2)/E6(R3) GCP requirements, CDISC standards (SDTM/ADaM), and regulatory submission data flows as they affect IT.
• Experience: Experience at a clinical-stage biotech with an outsource-heavy operating model where CROs manage EDC, RTSM, safety databases, and other trial systems.
• Experience: Experience with the Veeva Vault platform across multiple applications (eTMF, RIM, QMS, QualityDocs, CTMS).
• Experience: Strategic technology thinking — evaluates systems in the context of clinical program timelines, regulatory milestones, and company growth trajectory, not just technical requirements.
• Experience: 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.
• Experience: 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.
• Experience: Vendor and integration management — manages complex technology relationships with platform vendors, CROs, and implementation partners across multiple concurrent workstreams.

Pay

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Benefits

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

Equal Employment Opportunity

Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Reasonable Accommodation

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

Privacy

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines