Senior Manager, TMF Operations

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

The TMF Sr. Manager is a subject matter expert on processes and systems regarding essential eTMF study documents. Responsible for developing and executing procedures related to clinical trial documentation, to ensure GCP compliance and inspection readiness. 

Responsibilities

• Reporting to the Associate Director of Trial Master File Operations, the TMF Sr/Manager will assume responsibility for managing and performing eTMF Document Quality Reviews, Completeness / EDL Reviews and Inspection Readiness associated activities for the cardiorenal TMF operations unit
• Organizing and executing Quality & Completeness reviews and managing remediation and mitigation efforts based on Review outputs
• Collecting and analyzing data and results from Quality Reviews to aide the Trial teams to apply that information to process business and systems improvements
• Coordinating & supporting the EDL (expected document list) maintenance activities across all studies
• Working with Study Team leads and contributors of all levels of system familiarity and experience
• Independently will conduct document Visual inspection and Data analysis to best direct the Trial Master File management program in learning from current and ongoing review of quality indicators
• Partner with study teams to conduct Quality & Completeness checks of the TMF to ensure a constant state of  TMF inspection readiness and compliance with the company’s SOPs and Regulations

No matter your role at BridgeBio, successful team members are:

• 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

Education, Experience & Skills Requirements

• Bachelor’s degree with 6+ years of trial master file direct experience within a biopharmaceutical company or contract research organization, to include document processing, Quality Review, EDL Management and TMF analysis
• Demonstrable evidence of abilities to supervise other individuals, either through direct professional experience, or, clear examples where personally owned contributions led to the change in behavior needed by a peer to achieve the project goals
• Direct working experience of Veeva Vault eTMF (Submission, QC and EDL), as well as MS. Office suite to include MS Excel and MS Outlook primarily, with some MS Word and PowerPoint skills being advisable
• A communication style, both in writing and verbal presentation, that encourages engagement, interaction and conveys credibility and transparency
• A genuine desire to participate in the trial master file operations activities for Bridgebio in this capacity 

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