Associate Director/Director, IT Business Systems R&D jobs in United States
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BridgeBio · 1 day ago

Associate Director/Director, IT Business Systems R&D

BridgeBio is a biotech company focused on developing life-changing medicines for patients with unmet needs. As the Associate Director/Director of IT Business Systems for R&D, you will lead the design and implementation of pharmacovigilance systems and ensure compliance with regulatory standards while collaborating with various teams to enhance safety systems.

BiotechnologyHealth CareLife ScienceMedicalPharmaceutical
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Growth Opportunities
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H1B Sponsor Likelynote

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

Qualification

Veeva Vault SafetyPharmacovigilance systemsGxP complianceData migrationCross-functional collaborationStakeholder managementLeadership skillsCommunication skills

Required

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)
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

Preferred

Hands-on experience administering and supporting Veeva Vault Quality systems including QMS, Training, RIM, and eTMF is strongly preferred

Benefits

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
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
Market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits

Company

BridgeBio

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BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.

H1B Sponsorship

BridgeBio has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (4)
2022 (4)
2021 (1)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$4.35B
Key Investors
Blue OwlQatar Investment AuthorityKohlberg Kravis Roberts
2025-02-25Post Ipo Debt· $500M
2024-03-04Post Ipo Equity· $250M
2024-01-18Post Ipo Debt· $1.25B

Leadership Team

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Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
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Neil Kumar
CEO and Founder
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Company data provided by crunchbase