About Eidos Therapeutics & BridgeBio Pharma
Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.
To learn more about our story and company culture, visit us at eidostx.com/ | https://bridgebio.com
Who You Are
We are looking for a Director of I.T. Business Systems (R&D) to manage GxP Systems implementation, upgrade, support, and compliance across the enterprise and will be responsible, in collaboration with cross-functional partners, to craft and develop solutions in the areas CMC, Clinical Operations, Regulatory Affairs. The ideal candidate should have a solid technical background, be well-organized and independent, and possess a “can-do” attitude with excellent customer service.
The individual will be responsible for implementing and managing enterprise applications, continuously improving business processes, building strategic and functional business relationships, and overall compliance of the systems to regulatory standards.
Responsibilities
- Responsible for Veeva (Quality, QMS, RIM, eTMF, and Training) and other GxP systems
- Coordinate and execute in-depth tests, including end-user reviews and other post-implementation support of GxP systems and processes
- Develop and own the applications roadmap that aligns with business strategy
- Generates SOPs, work instructions, or business documents to outline workflows for GxP systems
- Create training plans and train others as needed to support GxP systems
- Support GxP team members lead and track day-to-day resolution of systems issues partnering with Veeva Managed Services
- Support planning, design, development, and launch of other business processes and operations systems supporting GxP activities. This includes gathering and analyzing data supporting business cases, proposed projects, and systems requirements
- Key business partners with the different Business teams in the U.S. and E.U. to meet the regulatory requirements
- Collaborate with I.T., Internal Auditors, and External Auditors for ongoing GxP SOX audits to ensure information and systems’ security, integrity, and reliability
- Provide architecture discipline and guidance to lead the technology delivery of the I.T. Portfolio
- Lead the implementation and transformation of application platforms to drive business efficiencies and improvements in partnership with the business stakeholders
- Develop and manage plans, requirements, architecture standards, and SDLC processes to support the application roadmap and strategy implementation
- Take ownership and lead overall governance of the GxP and ITGC controls for GxP/SOX Compliance, partnering with internal business partners, auditors, and peers to maintain the compliance program, including SOX, GxP, 21 CFR Part 11, GDPR for enterprise applications
- Lead the roadmap implementation supporting B.I. / Analytics platforms, providing dashboards, reporting, and data analytics to meet the R&D business requirements
- Ensure that all service level agreements are met, and SOP and/or processes are being followed
- Lead process improvement initiatives and assist with improving team efficiency, quality, and performance
- Develop key performance indicators and reporting to drive service optimization through SLAs
- Prepare system configuration and deployment cost estimates, budgets, and schedules
- Patient Champions, who put patients first and uphold strict ethical standards
- Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
- Truth Seekers, who are detailed, rational, and humble problem solvers
- Individuals Who Inspire Excellence in themselves and those around them
- High-quality executors, who execute against goals and milestones with quality, precision, and speed
No matter your role at BridgeBio, successful team members are:
Education, Experience & Skills Requirements
- Bachelor’s degree in the field of computer science or information systems or related field, or equivalent combination of education and experience required
- 10+ years working on I.T. implementation/management
- Experience in the Life Sciences industry, including implementation of solutions with a focus on GxP compliance and Computer System Validation
- Experience with Administering Veeva Vault (e.g., Veeva QualityDocs, QMS, RIM, Clinical) is required
- Project management Certification (PMP) or experience
- Understanding of ITIL processes, governance, and I.T. frameworks
- Must be able to troubleshoot, research, and solve technically challenging problems
- Familiar with Software Development Lifecycle (SDLC) in a regulated environment. Ability to lead new system selection processes, including requirement gathering, RFP development, and vendor selection
- Good communication skills and ability to interact with all company-level staff
- Strong interpersonal skills and a demonstrated ability to work effectively independently and in a team environment
- Detail-oriented, well-organized, and able to assume responsibility for project deliverables with limited supervision
- Ability to operate in a cross-functional / matrix environment
- Ability to effectively manage service providers supporting business systems
What We Offer
- Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
- A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
- An unyielding commitment to always putting patients first. Learn more about how we do this here
- A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
- A place where you own the vision – both for your program and your own career path
- A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
- Access to learning and development resources to help you get in the best professional shape of your life
- Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
- Flexible PTO
- Rapid career advancement for strong performers
- Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
- Partnerships with leading institutions
- Commitment to Diversity, Equity & Inclusion
$195,000 – $250,000 a year
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. The anticipated salary range for candidates for this role who will work in California is $195,000 to $250,000/year. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
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