Associate Director/Director, IT Business Systems R&D

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

What You'll Do

As Associate Director/Director, Safety Systems, you will lead the design, implementation, and continuous improvement of BridgeBio’s global pharmacovigilance (PV) systems landscape.  You will play a critical role in the migration of safety data and processes from Argus to Veeva Vault Safety, ensuring data integrity, compliance, and operational continuity.  This role will have a focus on Veeva Vault Safety and SafetyDocs with a secondary support role for other Veeva vaults such as Quality, RIM and eTMF.

In this role, you will define and execute the Safety Systems roadmap to support BridgeBio’s Commercial and Clinical functions—aligning technology, process, and compliance across the enterprise. You will partner closely with Drug Safety and Pharmacovigilance (DSPV), Quality, Regulatory, and Clinical teams to deliver innovative, scalable, and inspection-ready safety systems that protect patient safety and enable regulatory excellence.

You will also oversee vendors and Managed Service Providers to ensure consistent system performance, validated operations, and adherence to GxP, FDA, EMA, and GDPR regulations, while fostering a culture of proactive compliance and continuous improvement.

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

Where You'll Work

This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• 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 e