Associate Director/Director, IT Business Systems R&D

Role Summary

Lead the design, implementation, and continuous improvement of BridgeBio’s global pharmacovigilance IT systems landscape, with a focus on Veeva Vault Safety and SafetyDocs and secondary support for other Veeva vaults. Define and execute the Safety Systems roadmap to support Commercial and Clinical functions, ensuring data integrity, compliance, and operational continuity. Oversee vendors/Managed Service Providers to ensure validated operations and adherence to GxP, FDA, EMA, and GDPR regulations. This is a US-based remote role with quarterly or as-needed visits to the San Francisco office.

Responsibilities

• Support, administer, maintain IT systems supporting Pharmacovigilance and R&D, including Veeva Vault Safety, SafetyDocs, Quality, RIM and Clinical systems
• Lead and oversee the migration of data and processes from legacy systems to Veeva (e.g., Argus to Veeva Vault Safety) to ensure seamless transition, data integrity, and GxP compliance
• Partner with business leaders to understand their requirements and continuously improve user adoption and implement new systems, integrations, and GxP compliance initiatives
• Partner with Safety, Quality, Regulatory, and Clinical leaders to support business needs, implement roadmaps, identify, recommend solutions (e.g., Artificial Intelligence) to drive business value and accelerate innovation
• Work with Managed Service providers and internal IT teams for supporting and monitoring GxP-regulated systems to ensure high-quality service delivery
• Collaborate with CSV QA and compliance functions to validate and ensure alignment with regulatory requirements (e.g., GxP, HIPAA, GDPR)
• Establish governance, documentation, and change control procedures for safety systems to ensure sustained compliance and operational excellence
• Drive continuous improvement across the safety systems landscape by assessing emerging technologies and optimizing workflows that support BridgeBio’s DSPV strategy

Qualifications

• Bachelor’s degree in information technology, Computer Science, Business Administration, or related field; advanced degree preferred
• 7+ years of progressive IT experience within biotech/pharma, including at least 5 years supporting Drug Safety and Pharmacovigilance (DSPV) systems
• Demonstrated expertise in implementing, configuring, and maintaining Veeva Vault Safety and SafetyDocs, including system integrations, upgrades, and data migrations (e.g., Argus to Veeva)
• Hands-on experience administering and supporting Veeva Vault Quality systems including QMS, Training, RIM, and eTMF is strongly preferred
• Proven track record of managing validated GxP systems in compliance with FDA, EMA, and ICH guidelines, ensuring audit readiness and data integrity
• Strong understanding of pharmacovigilance processes, including AE intake, case management, and safety data exchange with CROs and affiliates
• Skilled in leading cross-functional collaboration across DSPV, Quality, Regulatory, and Clinical teams to ensure system alignment and process harmonization
• Experienced in vendor and Managed Service Provider oversight to ensure reliable, compliant, and high-quality system performance
• Strong communication, leadership, and stakeholder management skills with the ability to translate technical concepts into business outcomes

Education

• Bachelor’s degree in information technology, Computer Science, Business Administration, or related field; advanced degree preferred