
Associate Director – IT Business Systems R&D
BridgeBio
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $216,530 - $245,000 per year
Job Level
Senior
Tech Stack
Vault
About the role
- 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
Requirements
- 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
Benefits
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Veeva Vault SafetySafetyDocsGxP compliancedata migrationsystem integrationQuality Management System (QMS)Regulatory Information Management (RIM)eTMFArtificial Intelligencepharmacovigilance processes
Soft skills
leadershipstakeholder managementcross-functional collaborationcommunicationprocess harmonizationcontinuous improvementuser adoptionproblem-solvingdocumentationchange control
Certifications
Bachelor’s degree in information technologyBachelor’s degree in Computer ScienceBachelor’s degree in Business Administrationadvanced degree preferred